Phase II

Despite being represented in clinical research, no solutions have been found to circumvent the effects of Alopecia areata. However, there may be hope.
Although it looks that we’re on the downside of the COVID-19 pandemic in the U.S., biopharma companies are still working on developing better treatments and preventions.
Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.
Aldeyra Therapeutics will announce three clinical trials involving ADX-629, its first-in-class oral RASP modulator, at its 2022 Research & Development Day.
Four companies, Pipeline Therapeutics, Prothena, Neuroplast, and Taysha Gene Therapies, announced launches of clinical trials in the CNS space.
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
Biogen and Ionis Pharmaceuticals announced that their Phase I study of BIIB078 (IONIS-C9Rx) intended for ALS did not meet clinical endpoints, so they will discontinue the program.
The 2022 American Academy of Dermatology Annual Meeting saw several milestones for treatment explorations for inflammatory diseases. Here is some of the major news:
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
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