Phase III
Not surprisingly, the week between Christmas and New Year was quiet in terms of clinical trial news. However, there were some announcements. Here’s a look.
The decision to allow the release of Adbry follows positive results from the Phase III ECZTRA trials, which covered almost 2,000 patients living with moderate to severe atopic dermatitis.
BridgeBio Pharma reported topline data from Part A (Month 12) of its Phase III study of acoramidis for symptomatic transthyretin amyloid cardiomyopathy. The drug failed the study arm.
The company was assessing mavrilimumab as a potential therapeutic for COVID-19-related acute respiratory syndrome.
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.
Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.
PRESS RELEASES