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Minerva Shares Tank 72% As Schizophrenia Drug Misses Trial Goals

Minerva Shares Tank 72% As Schizophrenia Drug Misses Trial Goals

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Shares in Minerva Neurosciences Inc. (NERV) tanked 72% after the company's experimental drug roluperidone tailored for the treatment of schizophrenia did not meet its primary and key secondary endpoints in a Phase 3 trial.

The stock sank 72% to $3.71 on Friday. The clinical-stage biotech company said the trial conducted among 513 patients did not demonstrate “statistically significant difference from the placebo” in narrowing disease symptoms at week 12 of the treatment. However, the study did show that the roluperidone experimental drug was generally well tolerated, the company said.

“Even though this study didn’t achieve its primary and key secondary endpoints, primarily due to a larger than expected placebo effect at Week 12, results obtained with the 64 mg dose including the early onset of effect and functional improvement as measured by PSP suggest roluperidone merits continued investigation for the treatment of primary negative symptoms,” said Remy Luthringer, Executive Chairman and CEO of Minerva. “We intend to consult with the US FDA about the next steps in the development of roluperidone for this indication after we complete the analysis of the study data.”

Roluperidone is being developed as a treatment for the negative symptoms of schizophrenia that can persist chronically throughout patients’ lifetimes and contribute to poor quality of life and functional outcomes. The experimental drug has in the past been shown to potentially block serotonin receptors and sigma receptors, two receptors in the brain that are involved in the regulation of mood, cognition, sleep and anxiety.

In reaction to the announcement, five-star analysts Myles Minter at William Blair and Biren Amin at Jefferies on Friday both cut Minerva's stock to Hold from Buy. Amin, who has a $2 price target on the stock does not believe the FDA will consider benefit on a secondary endpoint when a study fails on a primary endpoint, leaving an unclear path for the drug.

The rest of Wall Street analysts have 3 Buy ratings on the stock adding up to a Moderate Buy consensus. The $15.75 average analyst price target now implies a staggering 325% upside potential in the shares in the coming 12 months. (See Minerva stock analysis on TipRanks).  

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The post Minerva Shares Tank 72% As Schizophrenia Drug Misses Trial Goals appeared first on TipRanks Financial Blog.

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#AAO22: Iveric Bio, undeterred by looming PDUFA for competitor, touts subgroup data on GA drug

CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic…

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CHICAGO — While its competitor is on the cusp of likely securing the first FDA nod, Iveric Bio is trudging ahead with its potential treatment for geographic atrophy, an advanced form of AMD, and has new data to support its upcoming NDA filing.

The biotech said its drug was more favorable than sham across all subgroups in the second Phase III study of the investigational complement C5 protein inhibitor, performing similarly to a previous, smaller late-stage trial.

Dubbed avacincaptad pegol, or Zimura (more on that later), the drug beat out sham across patient groups with differing GA disc areas, patients with varying levels of vision clarity based on how many letters they can correctly read, age groups and gender.

Earlier this month, Iveric said the drug met the primary endpoint in the GATHER2 study, reducing the mean rate of GA lesion growth by 14.3%, a p-value of 0.0064. Avacincaptad pegol also cleared the bar in the GATHER1 study last year at a p-value of 0.007. With those two successes, Iveric claims it was the first to do so in GA.

Competitor Apellis, with a Nov. 26 PDUFA date, only succeeded on that prespecified primary goal in one of its two Phase III studies. But 18- and 24-month follow-ups turned the tide in Apellis’ favor, with the reduction rates improving. Both biotechs, within minutes of each other, presented the new data on their GA drugs at the American Academy of Ophthalmology’s annual conference in the Windy City.

Iveric is also collecting data out to 24 months, with half of the patients receiving the drug every month for the first 12 months and then rerandomized to receive it either monthly or every other month to see if benefit can be maintained.

Dhaval Desai

“We don’t really look at the guys ahead of us to say whether it influences one way or another. It just means there either will be someone there or there won’t be someone there,” Dhaval Desai, Iveric development chief and SVP, told Endpoints News Friday morning.

Desai said Iveric thinks it has a unique asset on its hands with a pegylated RNA aptamer “as opposed to a pure biologic play like some of these other compounds out there for geographic atrophy.”

“When aptamers were first in vogue, a big thing around it is they’re small molecules and they have affinity to the target. But the small molecule piece of this, we didn’t really appreciate the potential benefit until recently,” he continued, referring to the GATHER2 topline data from earlier this month.

Iveric believes the safety side is strong, too, with an “extremely clean safety profile,” Desai said. The serious treatment emergent adverse events were higher in the sham group, at 16.7%, than in the Zimura-treated patients, at 13.3%. For both groups, less than 1% of the serious events were ocular-related in the study eye.

GATHER2 was initially supposed to kick off in the early days of 2020, but the Covid-19 pandemic led Iveric to readjust and hold off on enrolling patients until after the first wave of the virus slowed down with the thought that it would lead to fewer patient no-shows. To track how well they did at retaining patients, Iveric observed “injection fidelity” rates, or the number of injections actually delivered over the number of injections expected to be given in the study. The results: 91% for Iveric’s drug and 94% for the sham group.

To help with patient retention, Desai said Iveric gave extra stipends to sites to help arrange car services for patients to get vaccinated.

With the Phase III data from both studies now out in the world, Iveric’s NDA paperwork will be at the FDA’s doorsteps before the end of the first quarter of 2023. Iveric will try to speed up that six-month timeframe, Desai said. The thought is that patients could be on treatment for five, six or more years, Desai said. The mean age of patients on the drug was 76.3 years and 76.7 years for the sham group.

In the meantime, Iveric is focused on bringing everybody up to speed on the need for treatment, how quickly GA lesions can grow and how big of an impact they have on vision, and what the health economic impact is — diminished eyesight, falling, or losing the ability to get behind the wheel.

“I think the community as a whole nor, very frankly, industry really appreciates that very well right now, so those are all the things that not only do we have to educate the community on, but we have to educate ourselves on,” Desai said.

Internally, Iveric also has to decide whether to stick with the name Zimura, which Desai said came to them via Eyetech Pharmaceuticals, well before he or other leaders arrived.

“We’ll see,” he said.

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Industry groups call to block WTO IP waiver expansion to Covid-19 therapeutics

The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.
While…

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The WTO’s TRIPS Council in mid-October is expected to debate whether to extend the IP waiver for Covid-19 vaccines to therapeutics and diagnostics too.

While the Biden administration backed the original vaccine waiver, which critics note has not done much to expand access to vaccines as demand has dried up, US trade officials haven’t offered any perspective yet on whether to expand the waiver to Covid treatments.

The US Chamber of Commerce, as well as industry groups BIO and EFPIA, this week expressed “strong opposition” to any expansion of the WTO TRIPS waiver to therapeutics or diagnostics, arguing that waived IP protections damage the nation’s ability to innovate and compete.

Kevin O’Connor

Illinois-based IP attorney Kevin O’Connor at Neal, Gerber & Eisenberg told Endpoints News in a phone interview that he doesn’t think the vaccine waiver has done much so far.

“I don’t think it was the right solution for a demand problem,” O’Connor said. And an extension to therapeutics “would double down” on the same concept, except small molecule manufacturing is more straightforward than vaccine manufacturing. There’s also the question of whether there is a need for an extension given the voluntary licensing already in place.

BIO also noted that the expansion of a TRIPS waiver to therapeutics can create problems for therapeutics used for other indications too as these other indications “may be their only path to financial viability and sustained investment to fund future R&D initiatives.”

The industry group also noted the lack of a “supply and demand challenge globally that justifies the extension of an IP waiver” considering the fact that manufacturers are supplying therapeutics at a rate that outpaces demand.

The US Chamber of Commerce also noted that in the case of Covid-19 vaccine IP, “the waiver’s realization came long after its ostensible purpose was mooted by a large and growing surplus of COVID-19 vaccine supplies.”

Peter Maybarduk

But Public Citizen’s Peter Maybarduk told Endpoints these are “specious arguments and scare tactics,” adding, “Pharma is worried and that is a good thing for people.”

WTO members and developing countries pledged support for the waiver extension last summer, according to a read out of a meeting. Some even called for this extension to be discussed “with a sense of urgency given the fact that many least developed countries (LDCs) lack access to life-saving drugs and testing therapeutics.”

But other member countries “cautioned that more time was needed to conduct domestic consultations on a possible extension of the waiver to therapeutics and diagnostics” while:

Some members also flagged the importance of an evidence-based negotiation as there was no evidence that intellectual property did indeed constitute a barrier to accessing COVID-19 vaccines. Some also reiterated the need for members to fully make use of all the flexibilities that already exist in the TRIPS Agreement (including compulsory licensing) before requesting new flexibilities.

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Covid-19 roundup: Swiss biotech halts in-patient PhII study; Houston-based vaccine and Chinese mRNA shot nab EUAs in Indonesia

Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.
Kinarus Therapeutics…

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Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.

Kinarus Therapeutics announced on Friday that the Data and Safety Monitoring Board (DSMB) has reviewed the company’s Phase II study for its candidate KIN001 and has recommended that the study be stopped.

According to Kinarus, the DSMB stated that there was a low probability to show statistically significant results as the number of Covid-19 patients that are in the hospital is lower than at other points in the pandemic.

Thierry Fumeaux

“As many of our peers have learned since the beginning of the pandemic, it has become challenging to show the impact of therapeutic intervention at the current pandemic stage, given the disease characteristics in Covid-19 patients with severe disease. Moreover, there are also now relatively smaller numbers of patients that meet enrollment criteria, since fewer patients require hospitalization, in contrast to the situation earlier in the pandemic,” said Thierry Fumeaux, Kinarus CMO, in a statement.

Fumeaux continued to state that the drug will still be investigated in ambulatory Covid-19 patients who are not hospitalized, with the goal of reducing recovery time and the severity of the virus.

The KIN001 candidate is a combination of the small molecule inhibitor pamapimod and pioglitazone, which is currently used to treat type 2 diabetes.

The news has put a dampener on the company’s stock price $KNRS.SW, which is down 22% since opening on Friday.

Houston-developed vaccine and Chinese mRNA shot win EUAs in Indonesia

While Moderna and Pfizer/BioNTech’s mRNA shots to counter Covid-19 have dominated supplies worldwide, a Chinese-based mRNA developer and IndoVac, a recombinant protein-based vaccine, was created and engineered in Houston, Texas by the Texas Children’s Hospital Center for Vaccine Development  vaccine is finally ready to head to another nation.

Walvax and Suzhou Abogen’s mRNA vaccine, dubbed AWcorna, has been approved for emergency use for adults 18 and over by the Indonesian Food and Drug Authority.

Li Yunchun

“This is the first step, and we are hoping to see more families across the country and the rest of the globe protected, which is a shared goal for us all,” said Walvax Chairman Li Yunchun, in a statement.

According to Walvax, the vaccine is 83% effective against the “wild-type” of SARS-CoV-2 infection with the strength against the Omicron variants standing at around 71%. The shots are also not required to be stored in deep freeze conditions and can be put in storage at 2 to 8 degrees Celsius.

Walvax and Abogen have been making progress on their mRNA vaccine for a while. Last year, Abogen received a massive amount of funding as it was moving the candidate forward.

However, while the candidate is moving forward overseas, it’s still finding itself stuck in regulatory approval in China. According to a report from BNN Bloomberg, China has not approved any mRNA vaccines for domestic usage.

Meanwhile, PT Bio Farma, the holding company for state-owned pharma companies in Indonesia, is prepping to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses by 2024.

IndoVac’s primary series vaccines include nearly 80% of locally sourced content. Indonesia is seeking Halal Certification for the vaccine since no animal cells or products were used in the production of the vaccine. IndoVac successfully completed an audit from the Indonesian Ulema Council Food and Drug Analysis Agency, and the Halal Certification Agency of the Religious Affairs Ministry is expected to grant their approval soon.

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