Here are the latest stories being discussed in biopharma today:
1. FDA May Withdraw Amylyx’s ALS Treatment
The FDA has rarely pulled fully approved drugs unless there are safety concerns. However, Amylyx’s ALS treatment, Relyvrio, may prove to be an exception after failing to meet its primary-phase III endpoint. Further setbacks included missing every secondary endpoint, leaving the company with few options to consider. Amylyx previously pledged to consider withdrawing the drug if this last-stage study did not succeed. Given the adverse data, withdrawal may become a necessity should there prove to be no evidence of efficacy for patients with ALS.
2. FDA Delays Lilly’s Alzheimer’s Drug Decision
In an unexpected move, the FDA has postponed its decision on Eli Lilly’s Alzheimer’s drug, Donanemab, and plans to convene an advisory committee to deliberate further. The delay comes amid questions on safety, clinical trial design, and the withdrawal of patients from the drug once it has cleared amyloid plaques from the brain. This marks the second delay for the anticipated drug after an original approval decision slated for late 2023 was pushed to the first quarter of this year.
3. MacroGenics, AbbVie Cease ADC Development
MacroGenics and AbbVie have announced an end to the development of their ADAM9-targeted antibody-drug conjugate (ADC) following disappointing early trial data. Known as IMGC936, the ADC did not meet established clinical safety and efficacy benchmarks.
4. Inventiva Restarts Phase III MASH Trial Screening
Inventiva has resumed screening for its Phase III MASH trial after implementing voluntary pause recommendations from an independent data monitoring committee.
5. Amylyx Considers Withdrawing ALS Treatment After Phase III Failure
Following the failure of a critical Phase III trial, Biotech firm Amylyx is considering withdrawing its FDA-approved ALS treatment drug, Relyvrio. The crucial Phase III trial found the drug ill-performed against a placebo and failed to meet all secondary outcomes. Given the magnitude of the failure, the firm is considering retracting the drug.
6. David Baker Lab Releases Tool for Protein Design
David Baker’s lab at the University of Washington has unveiled new tools for predicting protein interactions with other molecules and designing proteins. The software draws on artificial intelligence (AI) to improve protein design accuracy. AI technology advancements in protein design have ignited a race among companies and research labs to develop cutting-edge tools in this field.
