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The Readout Damian Garde & Meghana Keshavan

Regeneron’s Covid-19 antibody may speed up recovery, small early trial shows

An antibody cocktail treatment from Regeneron Pharmaceuticals helped reduce levels of Covid-19 in infected patients, according to early results from a small study.

As STAT’s Matthew Herper reports, a high dose of the treatment, REGN-COV2, beat placebo at reducing levels of the virus after seven days. The improvements with a lower dose did not meet the threshold for statistical significance, meaning they could have been random chance. The study, which enrolled 275 Covid-19 patients who did not require hospitalization, is part of a larger effort that will test REGN-COV2 in more than 1,300 subjects.

Experts said it’s far too early to say whether Regeneron’s treatment can keep Covid-19 patients alive and out of the hospital, but the early look at data is a promising sign for the company’s ongoing studies.

Read more.

Everyone’s talking about diversity in Covid-19 trials. What happens post-pandemic?

Drug companies developing vaccines for Covid-19 have been unprecedentedly transparent about the racial and ethnic makeups of their clinical trials, with executives repeatedly promising to enroll the populations hardest hit by the pandemic. But once the crisis has passed, will the industry maintain that focus on equity?

Yvonne Greenstreet, chief operating officer of Alnylam Pharmaceuticals, said the industry has taken “a firm and deliberate step” when it comes to diversity in clinical trials. “It’s changed now from a nice-to-have to a have-to-have,” Greenstreet said during a STAT+ Conversation yesterday. “And once you decide, in a company and in an industry, that something’s a have-to-have, you put the commitment, the resources, your metrics, your goals, around trying to move the issue forward.”

And to overcome a history of understandable distrust in communities of color, the biomedical field needs to focus locally, said Andrew Plump, head of research and development at Takeda. “You have to look at where people have trust. People don’t trust the pharmaceutical industry. People don’t trust the government. But people do trust their minister, their rabbi, their local officials. … Somehow we have to find a way to really galvanize communities and do this at a grassroots level.”

Watch the conversation.

Suing the FDA is not going well for Catalyst

Catalyst Pharmaceuticals, which drew ire for charging $375,000 for a medicine once available for free, ran into a stumbling block when a federal judge dismissed its lawsuit against the FDA.

As STAT’s Ed Silverman reports, the issue stems from Firdapse, Catalyst’s treatment for a rare neuromuscular disorder. Before Firdapse won approval, a small, family-run company called Jacobus Pharmaceuticals provided it to patients at no charge under an FDA program. Months after Catalyst set its controversial price, the FDA approved Jacobus’s drug with a wide label that imperiled Firdapse’s market share. So Catalyst sued the FDA, calling the approval arbitrary and capricious.

But a federal judge disagreed, rejecting Catalyst’s argument that the agency violated its own rules, and dismissing the claim that Jacobus’s drug carries a misleading label.

Read more.

Wall Street is divided over Myovant’s future

Myovant Sciences, a company headed toward two FDA approvals for the same drug, has polarized analysts with a clinical disappointment that, depending on whom you ask, limits the company’s future revenue or amounts to a minor deviation.

The news is that relugolix, the company’s most advanced treatment, looked pretty much the same as standard of care when it came to increasing survival for men with prostate cancer in a Phase 3 trial. In that same trial, Myovant’s drug proved superior at lowering testosterone, but the lack of a clear survival benefit sent the company’s share price down more than 25%, erasing $360 million in value.

To Baird analyst Brian Skorney, that move was mostly justified. If relugolix can’t beat the standard treatment, a generic injection called leuprorelin, it’s unlikely to command much of a market share in prostate cancer once it wins approval, Skorney wrote in a note to investors. But to EvercoreISI’s Josh Schimmer, “the stock is acting as though this was a failed study when it was anything but.” According to him, doctors are “markedly enthusiastic” for Myovant’s drug because it can be given orally and appears to have a cleaner safety profile than leuprorelin.

We’ll find out who’s right soon enough, as the FDA has promised to decide on relugolix’s prostate cancer application in December.

More reads

  • New research shows older adults are still often excluded from clinical trials. (STAT)
  • Italian firm developing AstraZeneca's COVID-19 vaccine might go public. (Reuters)
  • BridgeBio's en route to proving out its 'Moneyball' for biotech model. (FierceBiotech)
  • For two decades, the FDA approval process for opioids had numerous shortcomings, study finds. (STAT Plus)

Thanks for reading! Until tomorrow,

Wednesday, September 30, 2020

STAT

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