FDA slams clinical hold on tiny psychedelics player's shot at bringing LSD-assisted therapy to more patients
Psychedelic therapy has emerged once again as a potentially promising path to treating neurological conditions, but one tiny biotech is now facing a holdup at the FDA in bringing its LSD program to more patients.
The FDA has slammed a clinical hold on MindMed’s IND application for a Phase IIb study testing its LSD-assisted therapy in patients with generalized anxiety disorder, the biotech said Tuesday.
Details — as they usually are with this sort of thing — were slim in a release, with MindMed only saying it expects further action from the FDA within 30 days. The biotech didn’t dive into what issues the agency flagged before it made its decision.
“Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic,” CEO Robert Barrow said in a statement. “We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible.”
Already far into microcap territory, shares in $MNMD were mostly trading flat on the news.
Not a whole lot is known about the New York biotech except that Barrow, formerly interim CEO and chief development officer, stepped into the full-time CEO role about a week ago, just in time to catch the bad news. His promotion came as the company’s former chairman Perry Dellelce stepped down from his role.
According to its website, the company is working on creating “experiential therapies” to address neurological conditions, including its LSD-assisted therapy program for anxiety, dubbed “Project Lucy.”