Zepbound, Covid-19 vaccine, Lykos’ MDMA

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Good morning. Today we discuss how psychedelics companies are responding to the negative advertising sentiment surrounding Lykos’ therapy, Zepbound’s results in MASH, and the fate of Novavax this fall.

Psychedelics companies see things positively

The day after a panel of FDA advisers rejected the use of MDMA-assisted therapy for post-traumatic stress disorder, shares in companies developing psychedelics fell as analysts said the decision could hinder the field’s ability to raise more funding .

But in interviews with STAT’s Meghana Keshavan, psychedelics companies said their optimism had not waned — and that the concerns raised about Lykos Therapeutics’ approach provided a clearer blueprint for what it might take to get such a drug approved.

“It’s not the medicine. It was the execution,” said Christian Angermayer, a financier deeply involved in the movement to turn long-shunned psychoactive substances, such as the psilocybin derived from so-called magic mushrooms, into approved drugs for depression and other mental illnesses.

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Zepbound improved liver scarring in MASH patients

An executive summary released yesterday found that Lilly’s blockbuster obesity drug improved living scarring, or fibrosis, in a Phase 2 MASH trial. This was a key result that observers were waiting for after Lilly reported positive results on the MASH resolution of this study in February, but did not reveal exact data on fibrosis.

Analysts made some caveats about the fibrosis data: There was a large proportion (30%) of patients given a placebo who experienced an improvement in fibrosis, and there was no dose response among the cohorts taking the drug. Still, the differences between the treatment groups and the placebo were statistically significant.

How much will obesity drugs like Zepbound ultimately affect the fate of liver-targeted MASH therapies? Some analysts and physicians expect that anti-obesity medications may support use in moderate MASH patients, but patients with severe MASH may ultimately benefit more from liver-targeted medications.

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Novavax will be able to deliver Covid-19 vaccines this fall

From Helen Branswell of STAT: The Food and Drug Administration’s Vaccine Advisory Panel voted unanimously yesterday to recommend that this fall’s Covid-19 shots be updated to target viruses in Omicron’s JN.1 line. That recommendation, if accepted by the FDA, is broad enough to ensure that Novavax, which has struggled to capture a substantial share of the Covid vaccine market, can supply products to the US this fall.

There was some discussion about whether it would be advisable to ask manufacturers to use a more recent virus, KP.2 – an offshoot of JN.1 – in the fall vaccine. Both Pfizer and Moderna indicated that they could produce both and deliver their product in August. But Novavax, which has a longer production lead time than messenger RNA vaccine makers, said that if the target for this fall’s vaccine was KP.2, it would not be able to supply the U.S. for the 2024 vaccination campaign- 2025.

Most members of the committee seemed to feel that the differences between the two were not significant enough to warrant a preferential recommendation for KP.2.

Withdrawal symptoms from antidepressants may not be as common as once thought

A new systematic review found that about 15% of people experienced withdrawal symptoms after stopping antidepressants, and in 2-3% of cases the symptoms were severe.

This analysis “should have been done much earlier,” says an external researcher. While it confirms that withdrawal symptoms occur at a clinically relevant frequency, it also showed a lower incidence than recent estimates from online surveys. These studies caused public alarm when they suggested that symptoms might occur in half or more of patients.

Read more from STAT’s Annalisa Merelli.

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