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Clene Energy: Nanocrystal Developer Pursues Remyelination vs. MS, ALS

In the Phase II VISIONARY-MS trial (NCT03536559), which evaluated CNM-Au8 in participants with stable relapsing remitting multiple sclerosis (RRMS), CNM-Au8…

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Rob Etherington, President and CEO of Clene Nanomedicine

Rob Etherington drives an electric car with a personalized license plate that reads “CLENE,” as in Clene Nanomedicine, the company he leads as President and CEO: “Many people ask me, is it because it’s kind-of clean energy? And I say, yeah, effectively.”

The license plate, like the company name, uses the Anglo-Saxon spelling for “clean.” The company develops treatments for neurodegenerative diseases through a platform that uses electro-crystal-chemistry to produce highly faceted, clean-surfaced (hence the name) nanocrystals. Those nanocrystals consist of pure transition elements—such as metals whose electrons can form chemical bonds in two shells rather than just one.

“We’ve purposely riffed off the word ‘clean,’ because we theorized from the beginning that we would have clean toxicity from the get-go,” Etherington told GEN Edge. “Our now-therapeutic technology does not use synthetic chemistry. What patients are drinking every morning has clean surfaces, which is to say, no chemistry at all. So that’s one of the reasons we call it clean.”

Clene’s lead product, CNM-Au8®, is a gold nanocrystal suspension being developed to treat amyotrophic lateral sclerosis (ALS), Parkinson’s disease—and multiple sclerosis (MS), for which the company recently announced positive topline Phase II data in a modified intent to treat (mITT) population. Each indication represents a potential commercial opportunity of >$1 billion per indication, Clene told investors last month.

In the Phase II VISIONARY-MS trial (NCT03536559), which evaluated CNM-Au8 in participants with stable relapsing remitting multiple sclerosis (RRMS), CNM-Au8 met its primary endpoint of low contrast letter acuity (LCLA) letter change in the clinically affected eye with a least squares [LS] mean difference of 3.13. CNM-Au8 also met its secondary endpoint of a statistically significant modified Multiple Sclerosis Functional Composite (mMSFC) score vs. placebo after 48 weeks.

Those results were generated from a modified intent-to-treat (mITT) population that excluded what Etherington said was invalid data from a nine-patient site for two reasons. One was because the site mistakenly allowed a patient to change how she navigated the 25-foot timed walk test during the study, from using a cane to using a wheeled walker.

The other reason, according to Etherington, was LCLA testing execution errors: “multiple rooms, different light boxes, variant ambient light conditions, different testers who actually tested the patients. Taken together, that confounded some of the data from the single site.”

“Novel and unique”

“We were attempting to look at patients that were fully controlled, and that’s a very important point: Nobody has ever looked at such a study population as novel and unique,” Etherington said.

Nearly all patients in VISIONARY-MS (92%) were on background therapy, with more than half of them (53%) on monoclonal antibodies.

“We are taking our drug on top of very controlled patients who are generally happy with their MS controls, but unhappy with their functional compromise. We showed in this study that in the modified intent-to-treat population, we had a p-value of p=0.056, showing a statistically significant change in low contrast, letter acuity,” Etherington added.

That p value was just above the FDA statistical significance threshold of p=0.05—though well below the pre-specified threshold for significance set at p=0.01 due to limited enrollment. Clene says it set a high significance threshold due to the challenge of recruiting patients during the COVID-19 pandemic. Clene ended the trial early in February, by which time only 73 participants were enrolled in VISIONARY-MS, just under half the planned 150.

“A whole series of COVID compromises meant that we had to close the study down, and we frankly wondered if we’d see anything at all, because a half-enrolled study is remarkably underpowered,” Etherington acknowledged. “But at p=0.056, we just missed the classical statistical significance by 0.006. Indeed, we were thrilled that the study was positive of the pre-specified mark.”

VISIONARY-MS was designed as a proof-of-concept study to establish that treatment of neuronal and glial energetic failure can support remyelination and neuroprotection in people living with MS.

Restoration through remyelination

Clene is among a number of companies and researchers looking to treat MS by using drugs to restore the myelin that forms around nerves.

Last month, investigators at Heinrich-Heine-University in Düsseldorf, Germany, published a study in eBioMedicine showing that medrysone—a previously marketed ophthalmic anti-inflammatory corticosteroid first approved in 1969—enhanced the repair of myelin in a mouse model of chronic demyelination.

“The application of the corticosteroid medrysone induces a robust myelin regeneration response marked by regulated astrocyte polarization and trophic factor expression,” concluded the research team, led by corresponding author Patrick Küry, PhD. “This drug may be of use as a potential treatment for late-stage MS where regenerative processes increasingly fail.”

Another drug recently studied for its remyelination potential in MS is digoxin, a cardiac glycoside used clinically to treat heart failure and arrhythmias. In July, a multi-institution research team led by Stephen D. Miller, PhD, Professor Emeritus of Microbiology-Immunology at Northwestern University Feinberg School of Medicine, published a study in Glia reporting that digoxin “completely ameliorated clinical disease symptoms and stimulated recovery of OL [oligodendrocyte] lineage cell numbers.”

“These findings provide critical pre-clinical evidence supporting future clinical trials of myelin-specific tolerance with myelin repair/regeneration drugs, such as digoxin, in MS patients,” Miller and colleagues added. Digoxin was first approved in 1954 and is now sold as a generic drug as well as under brand names that include Lanoxin® (Covis Pharma).

Capital challenge

Clene says the results from VISIONARY-MS support advancing CNM-Au8 into a Phase III program in people with MS who are experiencing progression independent of relapse activity.

“For a patient that’s controlled with their DMT [disease-modifying therapy], but still has neurological, functional deficit, these results demonstrated that CNM-Au8 may be the first therapy to potentially ever promote global neurological improvement as an adjunct to whatever drug they are on, and that we did that safely as well has led us to be very encouraged to design a Phase III study now,” Etherington said.

To advance into that Phase III program and continue current operations, Clene will need to surmount the challenge of raising additional capital, the company has acknowledged in its Form 10-Q filing for the second quarter. How much capital has yet to be determined pending the design of the pivotal study—a topic the company has discussed with regulators.

“We do know that it will be significant enough that we will indeed need to raise capital,” Etherington said. “That capital timeline will happen at the appropriate time when market conditions are right and when our data supports such.”

Clene finished the second quarter with $7.25 million in cash and cash equivalents, part of a total $26.28 million in cash and investments that the company told investors last month was sufficient to fund “key milestones in 2022.”

However, in its quarterly filing, Clene also projected that within the next 12 months: “We will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due, and we must obtain additional financing.”

Under a 42-month, up-to-$30 million term loan with Avenue entered into last year, Clene must maintain unrestricted cash and cash equivalents of at least $5 million to avoid acceleration of the full balance of its loan. “These conditions raise substantial doubt about the company’s ability to continue as a going concern,” Clene acknowledged.

Clene finished the second quarter with a net loss of $4.53 million, up from a net loss of $3.35 million in Q2 2021, on revenue that slid to $35 million from $201 million. For the first six months of 2022, Clene more than halved its net loss to $17.89 million from $43.11 million a year earlier.

Seven clinical trials

VISIONARY-MS is one of seven clinical trials focused on evaluating CNM-Au8, of which three are in MS. Clene has completed the first cohort of its Phase II REPAIR-MS trial (NCT03993171) in stable relapsing MS, and is evaluating a second cohort of non-active, progressive MS patients, with data set to read out in the first half of 2023.

Later this year, Clene expects to release topline data from the Healey ALS Platform Trial (NCT04414345  and NCT04297683), designed to assess CNM-Au8 and at least four other potential ALS treatments—zilucoplan (being developed by UCB), verdiperstat (Biohaven Pharmaceuticals, set to be acquired by Pfizer for $11.6 billion), pridopidine (Prilenia Therapeutics), and SLS-005 (also called trelahose injection; Seelos Therapeutics). The 800-patient Phase II/III trial is led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, and being conducted at more than 50 centers nationwide.

Should results from the Healy platform trial prove positive, Etherington said, “It could serve as a new drug application-worthy package that we would take to the FDA and ask for consideration.”

Last year, CNM-Au8 missed its primary endpoint of slowing disease progression as measured by Motor Unit Number Index (MUNIX) and its secondary endpoint (forced vital capacity or FVC) in the Phase II RESCUE-ALS trial (NCT04098406). But Clene insisted it found an efficacy signal for the MUNIX endpoint at week 12, and cited a pre-specified analysis in the subset of limb onset ALS in which, the company said, CNM-Au8 showed a “significant treatment effect” in MUNIX at week 12 and a “trend” for improvement at week 36.

“Befitting of Lou Gehrig, whose legacy is intertwined with the disease, we swung for the fences and ended with a stand-up triple,” Etherington said in a November 2021 statement.

On September 21, Clene presented positive updated survival results from the RESCUE-ALS trial open-label extension (OLE; NCT05299658) showing that, at up to 137 weeks following randomization, patients treated with CNM-Au8 demonstrated an approximately 70% decreased risk of death compared with patients treated with placebo. Last July, Clene reported 14 patients treated with placebo had died in the OLE, compared with five treated with CNM-Au8.

The updated results also showed a significant observed survival benefit with CNM-Au8 vs. predicted median survival derived from the published European Network for the Cure of ALS (ENCALS) prediction model.

CNM-Au8 is also being assessed in ALS through ongoing expanded access programs at the Healey Center (NCT04081714).

Restoring neuronal health

CNM-Au8 is designed to restore neuronal health and function by increasing the human body’s production and use of energy. Patients drink 60 ml consisting of trillions of gold nanocrystals suspended in water—nanocrystals small enough, according to Clene, to cross the blood-brain barrier and travel inside the cells of the human body, whose mitochondrial capacity is improved in response to cellular stresses induced by numerous disease-relevant neurotoxins.

By transmitting thousands of energy-supportive electrons per second per nanocrystal, CNM-Au8 rapidly catalyzes the oxidized form of nicotinamide adenine dinucleotide (NAD+). Once inside cells, CNM-Au8 stimulates production and use of adenosine triphosphate (ATP) while reducing oxidative stress and lowering levels of misfolded proteins harmful to human health.

Clene reasons that it can apply its approach to a variety of nanotherapeutics with unique energy profiles, generating a pipeline of drug candidates with broad applicability across different diseases.

In addition to CNM-Au8, Clene’s pipeline includes:

  • CNM-ZnAg, an ionic solution of zinc and silver that has shown both antiviral and antimicrobial properties. CNM-ZnAg is under study in a Phase II trial (NCT04610138) in symptomatic participants with acute COVID-19 that are not hospitalized at the time of enrollment, with data anticipated by year’s end.
  • CNM-AgZn17, a preclinical-phase topical gel polymer suspension of silver and zinc ions that is being developed to treat infectious diseases and accelerate wound healing.
  • CNM-PtAu7, a research-phase gold-platinum nanotherapeutic that, based on in vitro research, has shown broad-spectrum efficacy across a variety of tumor cell lines, according to Clene.

Clene was founded in December 2012 to discover and develop drugs for neurological diseases and other disorders. The company was formed to commercialize the research of Mark Mortenson, co-inventor of the technology platform behind Clene’s Clean-Surface Nanocrystal (CSN) therapeutics. Mortenson developed an electrocrystallization process to build a nanosuspension system that can serve as an electron donor to living cells–a process protected by more than 150 patents.

In 2020, Clene went public through a special purpose acquisition company (SPAC) merger with Tottenham Acquisition I Ltd.. The deal valued Clene at $542.5 million and generated about $31.9 million, including funds held in Tottenham’s trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Clene shareholders.

Clene’s just over 100 employees are split between its headquarters in Salt Lake City, and its manufacturing and quality operations in the town of North East, MD.

“If CNM-Au8 is positive in the Healy ALA Platform Study, and we’re writing a New Drug Application, and we’re planning for commercialization, and for a manufacturing operation that needs to perfectly scale to supply the drug, then that number will grow quite considerably,” Etherington said.

The post Clene Energy: Nanocrystal Developer Pursues Remyelination vs. MS, ALS appeared first on GEN - Genetic Engineering and Biotechnology News.

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First-ever social responsibility report of Chinese enterprises in Saudi Arabia incorporates BGI Genomics projects

On December 1, 2022, the Social Responsibility Report of Chinese Companies in Saudi Arabia was officially launched, which is the first such report released…

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On December 1, 2022, the Social Responsibility Report of Chinese Companies in Saudi Arabia was officially launched, which is the first such report released by the Contact Office of Chinese Companies in Saudi Arabia. BGI Genomics projects in the Kingdom have been incorporated into this report.

Credit: BGI Genomics

On December 1, 2022, the Social Responsibility Report of Chinese Companies in Saudi Arabia was officially launched, which is the first such report released by the Contact Office of Chinese Companies in Saudi Arabia. BGI Genomics projects in the Kingdom have been incorporated into this report.

This event was attended by around 150 representatives of Chinese and Saudi enterprises, Saudi government officials, experts in the field of sustainable development, CCTV, Xinhua News Agency, Saudi Press Agency, Arab News and other media professionals. This Report presents the key projects and best practices of Chinese enterprises to fulfil their social and environmental responsibilities while advancing the Kingdom’s industry development.

Chen Weiqing, the Chinese ambassador to Saudi Arabia, said in his video speech that the Report highlighted Chinese enterprises’ best practices in serving the local community, safe production, green and low-carbon development and promoting local employment. The release of the Report helps Chinese enterprises in the Kingdom to strengthen communication with the local community, laying a stronger foundation for future collaboration.

Epidemic control and accelerating post-COVID 19 recovery

BGI Genomics has been fulfilling its corporate social responsibilities and worked with the Saudi people to fight the COVID-19 epidemic.

In March 2020, Saudi Arabia was hit by the pandemic. The Saudi government decided to adopt BGI Genomics’ Huo-Yan laboratory solution in April 2020. At the forefront of the fight against the epidemic, the company has built six laboratories in Riyadh, Makkah, Madinah, Dammam and Asir within two months, with a total area of nearly 5,000 square meters and a maximum daily testing throughput of 50,000 samples.

By the end of December 2021, BGI Genomics had sent 14 groups of experts, engineers and laboratory technicians to Saudi Arabia, amounting to over 700 people, and tested more than 16 million virus samples, accounting for more than half of the tests conducted during this period. The company has successfully trained over 400 qualified Saudi technicians, and all laboratories have been transferred to local authorities for the operation.

In the post-epidemic era, the Huo-Yan laboratories can continue to make positive contributions to public health, working with local medical institutions and the public health system to make breakthroughs in areas such as reproductive health, tumour prevention and control, and prevention.

Enhancing genomic technology localization and testing capabilities

In July 2022, BGI Almanahil and Tibbiyah Holdings, a wholly owned subsidiary of the Saudi Faisaliah Group, announced a joint venture (JV) to establish an integrated, trans-omics medical testing company specializing in genetic testing.

This JV company will help improve Saudi Arabia’s local clinical and public health testing and manufacturing capabilities, promote the localization of strategic products that have long been imported, contribute to the implementation and realization of the Kingdom’s Vision 2030 roadmap, and significantly enhance local capacity for third-party medical testing services as well as local production of critical medical supplies.

BGI Genomics attaches great importance to fulfilling its corporate social responsibility and has released its social responsibility report for four consecutive years since 2017. Since its establishment, the company has always been guided by the goal of enhancing health outcomes for all, relying on its autonomous multi-omics platform to accelerate technological innovation, promote reproductive health, strengthen tumour prevention and control, and accurately cure infections, and is committed to becoming a global leader in precision medicine and covering the entire public health industry chain.

The company will continue to work together with all stakeholders to contribute to the Kingdom’s Vision 2030 and the Belt and Road Initiative and looks forward to growing with our partners.

 

About BGI Genomics

BGI Genomics, headquartered in Shenzhen China, is the world’s leading integrated solutions provider of precision medicine. Our services cover over 100 countries and regions, involving more than 2,300 medical institutions. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange.

 


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Alcohol deaths in the UK rose to record level in 2021

Nearly 10,000 people died from alcohol in 2021.

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Deaths from alcohol in the UK have risen to their highest level since records began in 2001, according to the latest data from the Office for National Statistics (ONS). In 2021, 9,641 people (14.8 per 100,000) died as a result of alcohol: a rise of 7.4% from 2020.

The leading cause of alcohol-specific deaths (deaths caused by diseases known to be a direct consequence of alcohol) continues to be liver disease. More than three-quarters (78%) of all alcohol deaths in 2021 were attributed to this cause. The remainder of the deaths were due to “mental and behavioural disorders because of the use of alcohol” and “accidental poisoning by, and exposure to, alcohol”.

Although there is no such thing as a safe level of drinking, and many people would feel the health benefits of reducing consumption, most of the risks of developing health problems and dying are skewed towards those who drink the most.

Between 2012 and 2019 alcohol-specific deaths remained relatively stable. It is no coincidence that deaths rose sharply during the first two years of the pandemic: those that were already drinking at harmful levels increased their consumption further during this period. Although liver disease can take years to develop, this process is accelerated when those drinking at harmful levels increase their consumption further.

Other statistics show that unplanned alcohol-related hospital admissions decreased during this period, which may have meant missed opportunities to provide help for those people experiencing problems with alcohol.

Looking beyond the headline figures, there are important differences in various groups within the population. Alcohol-specific deaths were not spread equally. For example, men were twice as likely to die as women. In 2021, 20.1 men per 100,000 died compared with 9.9 women.

Where you live in the UK matters, too, as deaths in Scotland are the highest, followed by Northern Ireland, Wales then and England – although the gap between the nations seems to be narrowing.

In England, deaths are highest in the north-east of England (20.4 per 100,000), which is twice as high as those in London (10.2 per 100,000). Although rates have increased in all regions; for example, there was a rise of 38% in south-west England from 2019 to 2021. This reflects what is already known about the relationship between deprivation and harm from alcohol. There is a two to fivefold higher risk of dying among lower-income groups compared with those from the higher-income groups.

Reflecting the growing trend of young people drinking less than older age groups, it is those aged 50 to 64 that account for most deaths due to liver disease. In 2021, for example, 39 people aged 25 to 29 died from alcohol-related liver disease, compared with 1,326 of those aged 50 to 59. This is related to a greater number of years of drinking but is also a general reflection that when older adults were younger, they tended to drink more than younger people do now.

Numbers of alcohol-specific deaths, by five-year age group and individual cause. Office for National Statistics – Alcohol-specific deaths in the UK: registered in 2021, National Records of Scotland and the Northern Ireland Statistics and Research Agency

Addressing harms

So what can be done to begin to address alcohol harms? It has been estimated that almost a quarter of drinkers in the UK drink above the recommended low-risk drinking guidelines. So this is a health and social issue that requires a national response. Low-impact initiatives, such as education and awareness raising, may not be enough.

The costs of alcohol to society are significant. A recent review estimated this to be £27 billion annually, with only half of this offset by tax revenue on alcohol products.

Timely access to specialist treatment can help to reduce the health risks associated with alcohol. Unfortunately, there have been significant cuts to funding for this type of intervention.

Around 80% of people classed as dependent on alcohol in England are not currently getting treatment support. While there has recently been extra funding for drug services to try and correct historic cuts, this has not been extended to alcohol. Reversing this by investing in services could help to reduce the rising number dying prematurely from alcohol.

A new strategy is long overdue

The last government strategy for alcohol was published in 2012, so there is a pressing need for a new one. This must address all the ways that the harms from alcohol can be tackled, from marketing and pricing to specialist treatment and recovery services.

A group, led by Liverpool MP Dan Carden, with cross-party support, recently called on the government to initiate an independent review of alcohol harm, along the lines of the review led by Dame Carol Black, which had a significant influence on drug policy and treatment funding.

Without such a review and strategy based on it, the harms caused by alcohol including premature death will continue to rise year after year. So much has changed since the last alcohol strategy in 2012 not least the current cost of living crisis. The outlook for investment in public health looks bleak, added to which this government doesn’t seem willing to curtail the efforts of the alcohol industry in marketing and protecting its products.

Harry Sumnall receives and has received funding from grant awarding bodies for alcohol and other drug research. He sits on grant-awarding funding panels, and is an unpaid scientific adviser to the MIND Foundation.

Ian Hamilton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Alcohol deaths in the UK rose to record levels in 2021

Nearly 10,000 people died from alcohol in 2021.

Published

on

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There has been a record rise in deaths from alcohol in the UK, according to the latest data from the Office for National Statistics (ONS). In 2021, 9,641 people died as a result of alcohol: a rise of 7.4% from 2020.

The leading cause of alcohol-specific deaths (deaths caused by diseases known to be a direct consequence of alcohol) continues to be liver disease. More than three-quarters (78%) of all alcohol deaths in 2021 were attributed to this cause. The remainder of the deaths were due to “mental and behavioural disorders because of the use of alcohol” and “accidental poisoning by, and exposure to, alcohol”.

Although there is no such thing as a safe level of drinking, and many people would feel the health benefits of reducing consumption, most of the risks of developing health problems and dying are skewed towards those who drink the most.

Between 2012 and 2019 alcohol-specific deaths remained relatively stable. It is no coincidence that deaths rose sharply during the first two years of the pandemic: those that were already drinking at harmful levels increased their consumption further during this period. Although liver disease can take years to develop, this process is accelerated when those drinking at harmful levels increase their consumption further.

Other statistics show that unplanned alcohol-related hospital admissions decreased during this period, which may have meant missed opportunities to provide help for those people experiencing problems with alcohol.

Looking beyond the headline figures, there are important differences in various groups within the population. Alcohol-specific deaths were not spread equally. For example, men were twice as likely to die as women. In 2021, 20.1 men per 100,000 died compared with 9.9 women.

Where you live in the UK matters, too, as deaths in Scotland are the highest, followed by Northern Ireland, Wales then and England – although the gap between the nations seems to be narrowing.

In England, deaths are highest in the north-east of England (20.4 per 100,000), which is twice as high as those in London (10.2 per 100,000). Although rates have increased in all regions; for example, there was a rise of 38% in south-west England from 2019 to 2021. This reflects what is already known about the relationship between deprivation and harm from alcohol. There is a two to fivefold higher risk of dying among lower-income groups compared with those from the higher-income groups.

Reflecting the growing trend of young people drinking less than older age groups, it is those aged 50 to 64 that account for most deaths due to liver disease. In 2021, for example, 39 people aged 25 to 29 died from alcohol-related liver disease, compared with 1,326 of those aged 50 to 59. This is related to a greater number of years of drinking but is also a general reflection that when older adults were younger, they tended to drink more than younger people do now.

Numbers of alcohol-specific deaths, by five-year age group and individual cause. Office for National Statistics – Alcohol-specific deaths in the UK: registered in 2021, National Records of Scotland and the Northern Ireland Statistics and Research Agency

Addressing harms

So what can be done to begin to address alcohol harms? It has been estimated that almost a quarter of drinkers in the UK drink above the recommended low-risk drinking guidelines. So this is a health and social issue that requires a national response. Low-impact initiatives, such as education and awareness raising, may not be enough.

The costs of alcohol to society are significant. A recent review estimated this to be £27 billion annually, with only half of this offset by tax revenue on alcohol products.

Timely access to specialist treatment can help to reduce the health risks associated with alcohol. Unfortunately, there have been significant cuts to funding for this type of intervention.

Around 80% of people classed as dependent on alcohol in England are not currently getting treatment support. While there has recently been extra funding for drug services to try and correct historic cuts, this has not been extended to alcohol. Reversing this by investing in services could help to reduce the rising number dying prematurely from alcohol.

A new strategy is long overdue

The last government strategy for alcohol was published in 2012, so there is a pressing need for a new one. This must address all the ways that the harms from alcohol can be tackled, from marketing and pricing to specialist treatment and recovery services.

A group, led by Liverpool MP Dan Carden, with cross-party support, recently called on the government to initiate an independent review of alcohol harm, along the lines of the review led by Dame Carol Black, which had a significant influence on drug policy and treatment funding.

Without such a review and strategy based on it, the harms caused by alcohol including premature death will continue to rise year after year. So much has changed since the last alcohol strategy in 2012 not least the current cost of living crisis. The outlook for investment in public health looks bleak, added to which this government doesn’t seem willing to curtail the efforts of the alcohol industry in marketing and protecting its products.

Harry Sumnall receives and has received funding from grant awarding bodies for alcohol and other drug research. He sits on grant-awarding funding panels, and is an unpaid scientific adviser to the MIND Foundation.

Ian Hamilton does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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