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Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression

Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression
PR Newswire
DURHAM, N.C. and BEIJING, Sept. 26, 2022

Data demonstrated that a single administration of BRII-2…



Brii Biosciences Announces Top-line Results from Phase 1 Study of BRII-296, A Long-Acting Therapy in Development for Postpartum Depression

PR Newswire

  • Data demonstrated that a single administration of BRII-296 at 600 mg delivered a favorable pharmacokinetic profile and is safe and well-tolerated in healthy subjects
  • Findings suggest BRII-296 has potential to provide a safe and effective, one-time injectable treatment option to people with PPD in an outpatient setting
  • Company has identified an optimal dose regimen for BRII-296 for the upcoming Phase 2 study expected to commence by end of 2022

DURHAM, N.C. and BEIJING, Sept. 26, 2022 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced top-line results from a Phase 1 study evaluating its long-acting, single-injection therapy, BRII-296, in development for the treatment of postpartum depression (PPD). These data show that a single treatment via intramuscular (IM) injection of 600 mg of BRII-296 achieved dose linearity, early drug absorption, gradual and extended release profiles without the need for dose titration or tapering, providing confidence that this dose has potential to achieve clinical efficacy in the treatment of PPD. The selected dose regimen will be evaluated in a Phase 2 clinical trial that is expected to begin this year.

BRII-296 acts as a novel gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) with a unique long-acting formulation that does not require cessation of breastfeeding and enables the drug to be effective for weeks after the patient leaves the injection appointment. It is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD and may offer substantial clinically meaningful advantages over currently available treatment options for PPD.

"We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the U.S. affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalization, repeat therapy and daily doses of treatment," said Ji Ma, Ph.D., Vice President of Preclinical Development and Clinical Pharmacology at Brii Bio, and lead author. "These data reinforce the potential for BRII-296 to redefine the PPD treatment landscape by providing a one-time, outpatient therapy that may effectively treat a range of depressive symptoms while maintaining a favorable safety and tolerability profile, including minimal exposure to breastfed infants."

"Initial results from this study are an important step forward as we continue to advance the development of BRII-296 in a robust and thoughtfully designed Phase 2 clinical study later this year that will incorporate fundamental patient experiences and preferences," said Aleksandar Skuban, M.D., CNS Diseases Therapy Area Head of Brii Bio. "This comprehensive approach to development is critical in areas such as PPD where there are often considerable barriers to accessing care, in part because of wide-reaching social stigmas and a lack of disease awareness. This program reinforces Brii's dedication to operating at the intersection of scientific innovation and patient insights in order to inform the full spectrum of strategic development in mental health conditions such as PPD as well as our broader global public health-inspired pipeline."

Data from healthy subjects in cohorts 1-15 were presented in a poster, titled Safety, Tolerability, and Pharmacokinetics of BRII-296, An Extended-Release Injectable Aqueous Suspension Formulation of Brexanolone in Healthy Adult Subjects, at the International Marcé Society Conference taking place in London, United Kingdom September 19-23, 2022. The full Phase 1 dataset will be presented at a scientific meeting later this year.

About BRII-296 Phase 1 Trial

The completed open-label, Phase 1, single ascending dose study assessed the safety, tolerability and PK of BRII-296 as a single-injection treatment option for PPD in 116 subjects enrolled across 16 cohorts. Three formulation concentrations (100 mg/mL, 200 mg/mL and 300 mg/mL) were administered via one or more IM injections to healthy adults at total dose levels of 30 mg, 75 mg, 100 mg, 200 mg, 300 mg and 600 mg. In addition, oral prophylactic treatment, or local steroid administration with BRII-296 (Depo Medrol via co-injection or admix) were evaluated to manage local injection site reactions (ISRs). The local steroid administration was shown in the study to effectively manage injection site reactions (ISRs).

Of the 116 subjects, 98 subjects reported treatment emergent adverse events (TEAEs), with the majority considered drug-related and attributed to ISRs. Most ISRs were mild to moderate in severity and none lead to premature discontinuation from the study. There were no life threatening TEAEs, TEAEs leading to premature discontinuation of study, SAEs, or deaths.

About Postpartum Depression

Postpartum depression (PPD) is the most common psychological condition impacting people after giving birth. Affecting approximately 900,000 birthing people in the U.S. each year, including those who have miscarried or have had a stillbirth, PPD can present significant physical and mental health risks to the mother. In fact, suicide and overdose are the leading causes of death for childbearing people in the first year following pregnancy. Some healthcare providers believe the prevalence of PPD could be at least double, given unreported and untreated cases. PPD can also have negative effects on the maternal-infant relationship and it may lead to longer-term child development problems. Despite the prevalence and societal impact of PPD, currently approved treatment options remain limited and are associated with significant disruptions to daily life, including required hospitalization, repeat therapy and daily doses of treatment.

About BRII-296

BRII-296 is a novel, single injection therapeutic candidate in development for the treatment and prevention of postpartum depression (PPD). It acts as a gamma-aminobutyric acid A (GABAa) receptor positive allosteric modulator (PAM) and is designed to provide a rapid, profound and sustained reduction in depressive symptoms of PPD with the potential to lead to greater adherence, convenience and fewer side effects compared to the current standard of care. BRII-296 will continue to be evaluated in an upcoming Phase 2 study for the treatment of PPD and is also in development for the prevention PPD.

About Brii Bio

Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company based in China and the United States committed to advancing therapies for significant infectious diseases, such as hepatitis B, COVID-19, human immunodeficiency virus (HIV) infection, multi-drug resistant (MDR) or extensive drug resistant (XDR) gram-negative infections, and other illnesses, such as the central nervous system (CNS) diseases, which have significant public health burdens in China and worldwide. For more information, visit

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Costco Tells Americans the Truth About Inflation and Price Increases

The warehouse club has seen some troubling trends but it’s also trumpeting something positive that most retailers wouldn’t share.



Costco has been a refuge for customers during both the pandemic and during the period when supply chain and inflation issues have driven prices higher. In the worst days of the covid pandemic, the membership-based warehouse club not only had the key household items people needed, it also kept selling them at fair prices.

With inflation -- no matter what the reason for it -- Costco  (COST) - Get Free Report worked aggressively to keep prices down. During that period (and really always) CFO Richard Galanti talked about how his company leaned on vendors to provide better prices while sometimes also eating some of the increase rather than passing it onto customers.

DON'T MISS: Why You May Not Want to Fly Southwest Airlines

That wasn't an altruistic move. Costco plays the long game, and it focuses on doing whatever is needed to keep its members happy in order to keep them renewing their memberships.

It's a model that has worked spectacularly well, according to Galanti.

"In terms of renewal rates, at third quarter end, our US and Canada renewal rate was 92.6%, and our worldwide rate came in at 90.5%. These figures are the same all-time high renewal rates that were achieved in the second quarter, just 12 weeks ago here," he said during the company's third-quarter earnings call.

Galanti, however, did report some news that suggests that significant problems remain in the economy.

Costco has done an incredibly good job at holding onto members.

Image source: Xinhua/Ting Shen via Getty Images

Costco Does See Some Economic Weakness

When people worry about the economy, they sometimes trade down when it comes to retailers. Walmart executives (WMT) - Get Free Report, for example, have talked about seeing more customers that earn six figures shopping in their stores.

Costco has always had a diverse customer base, but one weakness in its business may be a warning sign for its rivals like Target (TGT) - Get Free Report, Best Buy (BBY) - Get Free Report, and Amazon (AMZN) - Get Free Report. Galanti broke down some of the numbers during the call.

"Traffic or shopping frequency remains pretty good, increasing 4.8% worldwide and 3.5% in the U.S. during the quarter," he shared.

People shopped more, but they were also spending less, according to the CFO.

"Our average daily transaction or ticket was down 4.2% worldwide and down 3.5% in the U.S., impacted, in large part, from weakness in bigger-ticket nonfood discretionary items," he shared.

Now, not buying a new TV, jewelry, or other big-ticket items could just be a sign that consumers are being cautious. But, if they're not buying those items at Costco (generally the lowest-cost option) that does not bode well for other retailers.

Galanti laid out the numbers as well as how they broke down between digital and warehouse.

"You saw in the release that e-commerce was a minus 10% sales decline on a comp basis," he said. "As I discussed on our second quarter call and in our monthly sales recordings, in Q3, big-ticket discretionary departments, notably majors, home furnishings, small electrics, jewelry, and hardware, were down about 20% in e-com and made up 55% of e-com sales. These same departments were down about 17% in warehouse, but they only make up 8% in warehouse sales."

Costco's CFO Also Had Good News For Shoppers

Galanti has been very open about sharing information about the prices Costco has seen from vendors. He has shared in the past, for example, that the chain does not pass on gas price increases as fast as they happen nor does it lower prices as quick as they sometimes fall.

In the most recent call, he shared some very good news on inflation (that also puts pressure on Target, Walmart, and Amazon to lower prices).

"A few comments on inflation. Inflation continues to abate somewhat. If you go back a year ago to the fourth quarter of '22 last summer, we had estimated that year-over-year inflation at the time was up 8%. And by Q1 and Q2, it was down to 6% and 7% and then 5% and 6%," he shared. "In this quarter, we're estimating the year-over-year inflation in the 3% to 4% range."

The CFO also explained that he sees prices dropping on some very key consumer staples.

"We continue to see improvements in many items, notably food items like nuts, eggs and meat, as well as items that include, as part of their components, commodities like steel and resins on the nonfood side," he added.


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“What’s More Tragic Is Capitalism”: BLM Faces Bankruptcy As Founder Cullors Is Cut By Warner Bros

"What’s More Tragic Is Capitalism": BLM Faces Bankruptcy As Founder Cullors Is Cut By Warner Bros

Authored by Jonathan Turley,

Two years…



"What's More Tragic Is Capitalism": BLM Faces Bankruptcy As Founder Cullors Is Cut By Warner Bros

Authored by Jonathan Turley,

Two years ago, I wrote columns about companies pouring money into Black Lives Matter to establish their bona fides as “antiracist” corporations. The money continued to flow despite serious questions raised about BLM’s management and accounting. Democratic prosecutors like New York Attorney General Letitia James showed little interest in these allegations even as James sought to disband the National Rifle Association (NRA) over similar allegations. At the same time, Black Lives Matter co-founder Patrisse Cullors cashed in with companies like Warner Bros. eager to give her massive contracts to signal their own reformed status. It now appears that BLM is facing bankruptcy after burning through tens of millions and Warner Bros. cut ties with Cullors after the contract produced no — zero — new programming.

Some states belatedly investigated BLM as founders like Cullors seemed to scatter to the winds.

Gone are tens of millions of dollars, including millions spent on luxury mansions and windfalls for close associates of BLM leaders.

The usual suspects gathered around the activists like former Clinton campaign general counsel Marc Elias, who later removed himself from his “key role” as the scandals grew.

When questions were raised about the lack of accounting and questionable spending, BLM attacked critics as “white supremacists.”

Warner Bros. was one of the companies eager to grab its own piece of Cullors to signal its own anti-racist virtues.  It gave Cullors a lucrative contract to guide the company in the creation of both scripted and non-scripted content, focusing on reparations and other forms of social justice. It launched a publicity campaign for everyone to know that it established a “wide-ranging content partnership” with Cullors who would now help guide the massive corporation’s new programming. Calling Cullors “one of the most influential thought leaders in American public life,” Warner Bros. announced that she was going to create a wide array of new programming, including “but not limited to live-action scripted drama and comedy series; longform/event series; unscripted docuseries; animated programming for co-viewing among kids, young adults and families; and original digital content.”

Some are now wondering if Warner Bros. ever intended for this contract to produce anything other than a public relations pitch or whether Cullors took the money and ran without producing even a trailer for an actual product. Indeed, both explanations may be true.

Paying money to Cullors was likely viewed as a type of insurance to protect the company from accusations of racial insensitive. After all, the company was giving creative powers to a person who had no prior experience or demonstrated talent in the area. Yet, Cullors would be developing programming for one of the largest media and entertainment companies in the world.

One can hardly blame Cullors despite criticizism by some on the left for going on a buying spree of luxury properties.

After all, Cullors was previously open about her lack of interest in working with “capitalist” elements. Nevertheless, BLM was run like a Trotskyite study group as the media and corporations poured in support and revenue.

It was glaringly ironic to see companies like Warner Bros. falling over each other to grab their own front person as the group continued boycotts of white-owned businesses. Indeed, if you did not want to be on the wrong end of one of those boycotts, you needed to get Cullors on your payroll.

Much has now changed as companies like Bud Light have been rocked by boycotts over what some view as heavy handed virtue signaling campaigns.

It was quite a change for Cullors and her BLM co-founder, who previously proclaimed “[we] are trained Marxists. We are super versed on, sort of, ideological theories.” She denounced capitalism as worse than COVID-19. Yet, companies like Lululemon rushed to find their own “social justice warrior” while selling leggings for $120 apiece.

When some began to raise questions about Cullors buying luxury homes, Facebook and Twitter censored them.

With increasing concerns over the loss of millions, Cullors eventually stepped down as executive director of the Black Lives Matter Global Network Foundation, as others resigned.  At the same time, the New York Post was revealing that BLM Global Network transferred $6.3 million to Cullors’ spouse, Janaya Khan, and other Canadian activists to purchase a mansion in Toronto in 2021.

According to The Washington Examiner, BLM PAC and a Los Angeles-based jail reform group paid Cullors $20,000 a month. It also spent nearly $26,000 on meetings at a luxury Malibu beach resort in 2019. Reform LA Jails, chaired by Cullors, received $1.4 million, of which $205,000 went to the consulting firm owned by Cullors and her spouse, according to New York magazine.

Once again, while figures like James have spent huge amounts of money and effort to disband the NRA over such accounting and spending controversies, there has been only limited efforts directed against BLM in New York and most states.

Cullors once declared that “while the COVID-19 illness is tragic, what’s more tragic is capitalism.” These companies seem to be trying to prove her point. Yet, at least for Cullors, Warner Bros. fulfilled its slogan that this is all “The stuff that dreams are made of.”

Tyler Durden Sun, 05/28/2023 - 16:00

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Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Discriminating against fat people is now illegal in New York City, after…



Under Pressure From Fat Activists, NYC Bans Weight Discrimination

Discriminating against fat people is now illegal in New York City, after Mayor Eric Adams on Friday signed off on a ban that will affect not only employment, but also housing and access to public accommodations -- a term that encompasses most businesses. 

We're in safe company using the word "fat," as champions of the cause refer to themselves as "fat activists." With the mayor's signature, two more categories -- both weight and height -- are added to New York City's list of protected personal attributes, which already included race, gender, age, religion and sexual orientation. 

As Mayor Adams signs the law, self-described (and everyone else-described) fat activist Tigress Osborn consumes more than her share of the backdrop (James Messerschmidt for NY Post)

Embracing one of 2023's innumerable strains of Orwellian brainwashing, Adams declared, "Science has shown that body type is not a connection to if you’re healthy or unhealthy. I think that’s a misnomer that we’re really dispelling.”

Even the Centers for Disease Control and Prevention say obesity is an invitation to a host of maladies, including to high blood pressure Type 2 diabetes, coronary heart disease, stroke, gall bladder disease, many types of cancer, mental illness and difficulty with physical functioning. 

“Size discrimination is a social justice issue and a public health threat," said Councilmember Shaun Abreu, who introduced the measure. "People with different body types are denied access to job opportunities and equal wages — and they have had no legal recourse to contest it," said Abreu. "Worse yet, millions are taught to hate their bodies." 

A full 69% of American adults are overweight or obese, but our woke overlords would have us believe the real "public health threat" is a nice restaurant that doesn't want Two-Ton Tessie working the reception desk, or a landlord who's leary of a 400-pound man breaking a toilet seat or collapsing a porch.  

The enticingly-named Tigress Osborn, who chairs the National Association to Advance Fat Acceptance, said New York's ban "will ripple across the globe" -- perhaps something like what would happen if the hefty Smith College Africana Studies graduate were dropped into a swimming pool.  

Councilmember Shaun Abreu said he gained 40 pounds during the pandemic lockdowns and noticed people treated him differently

The New York Times reports that witnesses who testified as the measure was under consideration included "a student at New York University said that desks in classrooms were too small for her [and] a soprano at the Metropolitan Opera [who] said she had faced body shaming and pressure to develop an eating disorder." 

Some have dared to speak out against the measure. “This is another mandate where enforcement will be primarily through litigation, which imposes a burden on employers, regulators and the courts,” said Kathryn S. Wylde, president of the Partnership for New York City, speaking in April. 

Implicitly putting the weight ordinance in the same category as Brown vs Board of Education, Abrue said, “Today is a monumental advancement for civil rights, size freedom and body positivity and while our laws are only now catching up to our culture, it is a victory that I hope will cause more cities, states and one day the federal government to follow suit.” 

Taking effect in six months, the law has an exemption for employers "needing to consider height or weight in employment decisions" -- but "only where required by federal, state, or local laws or regulations or where the Commission on Human Rights permits such considerations because height or weight may prevent a person from performing essential requirements of a job." 

We pray there's a federal exemption for employers of strippers and lap dancers. 

Think we're joking? We remind you that the chair of the National Association to Advance Fat Acceptance is named "Tigress" -- and this is her Twitter profile banner photo:

via Tigress @iofthetigress
Tyler Durden Sun, 05/28/2023 - 15:30

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