fashion -WSS

fashion

author：entertainment 2025-09-30 06:09:35 - browse：66742

Adam's take main illustration — Molly Ferguson/STAT

Annovis Bio had my biotech bull%^&! meter running red after it made a late change to the design of a Phase 3 study in Parkinson’s disease. But then I got an extraordinary explanation from CEO Maria Maccecchini. Now, I’m less worried about data spin because, by her own admission, the odds that the study succeeds, post endpoint change, are a lot lower.

Results from the completed Parkinson’s study, which is investigating Annovis’ drug called buntanetap, are well past due because of what the company has described as ongoing “data cleaning efforts.” The delay was announced on Jan. 24. Two weeks later, on Feb. 6, the primary efficacy endpoint of the study was changed, according to an update posted to the U.S. government’s clinical trials database.

Red flag, I thought, until I emailed Maccecchini, asking for an explanation. In response, she told me Annovis made the key endpoint change in August, based on a recommendation from officials at the Food and Drug Administration after the agency had reviewed data from an interim analysis of the study. It took the company another six months to update the study design in the ClinicalTrials.gov database, for reasons she did not explain.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Jerome Adams on the need for new antivirals for Covid
Next article： In 'major milestone,' FDA approves first cell therapy for solid tumors

knowledge

hotspot

WSS

Letters to First Opinion on caregivers, digital health, and more

WATCH: Why do our ears pop?

Readout LOUD podcast: Pharma in Washington, Alnylam, and Gilead

Readout LOUD podcast: Pharma in Washington, Alnylam, and Gilead

ASCO Daily Recap: Safety data from Novartis, survival from Pfizer

In 'major milestone,' FDA approves first cell therapy for solid tumors

focus

fashion

entertainment

At least 13 dead in Texas as scorching temps continue

Cord blood banking comes at a high cost to babies

Over 800 arrested across France in 3rd night of riots after fatal police shooting of teen

FDA warns medical device makers about rise in fabricated data

Medical records are filled with copy

Measles policy set amid Florida outbreak alarms vaccine proponents

Peter Hotez and the public health issue of online harassment

Shifting the focus from loneliness to social health

Hollywood unions extend contract negotiations for actors

FDA warns medical device makers about rise in fabricated data

hotspot

Reporting on presidential health from Reagan to Trump and Biden

The Pandemic Treaty must support building strong health systems

A new drug could help frostbite victims avoid its ravages

MD Anderson's Padmanee Sharma responds to research credit suit

Secretariat’s lessons for human medicine

Ring Therapeutics, a Flagship gene therapy startup, lays off 20% of staff

entertainment

knowledge

hotspot

focus