Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine headlines to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
MindMed Doses First Patient in Phase 2b Trial
“The initiation of our Phase 2b clinical trial, the largest well-controlled clinical trial of LSD ever conducted, represents a major milestone for MindMed and for the many patients suffering from GAD,” said Robert Barrow, Chief Executive Officer and Director of MindMed.
“This exciting next step in the advancement of LSD builds on the positive topline data presented by our partners at University Hospital Basel in May 2022, which demonstrated the rapid, durable, and statistically significant effects of LSD and its potential to safely mitigate symptoms of anxiety and depression. The results of our Phase 2b trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials, as we continue our efforts to bring a new potential treatment to the millions of people living with GAD.”
New Study Shows Psilocybin Reduces Drinking in 83% of Patients
Conducted by researchers at NYU Langone, one of the nation’s premier academic medical centers, a new study has just been released on the positive effects of psilocybin on alcohol addiction.
Two doses of psilocybin were shown to reduce heavy drinking by 83% among heavy drinkers when combined with psychotherapy. The study also showed that eight months after their first dose, almost half (48%) of those who received psilocybin stopped drinking altogether (compared with 24% of the placebo group).
B.More Receives FDA Approval for Psilocybin Phase 2b Trial
Following on the results by the research team at NYC Langone, the FDA immediately gave a green light to a Phase 2b trial.
“Given the amazing results of the psilocybin for AUD Phase 2a trial that our principal investigator, Dr. Bogenschutz, just published in JAMA Psychiatry, we are thrilled to have received FDA approval to begin our Phase 2b trial”, said Carey Turnbull, co-founder and CEO of B.More. “With a reported 83% average reduction in alcohol consumption among heavy drinkers, the results of Dr. Bogenschutz’s recent trial point to the clear potential of psilocybin as a breakthrough in the way we treat AUD.”
GH Research’s Financial and Business Results
The secretive DM company released its Q2 financial and business results, showing a very strong cash position of $265 million and an expansion of their pipeline beyond tlead candidate GH001 for the treatment of TRD. GH001 is moving to Phase 2b in European clinical trials, and they’ve started both an FDA trial and a new Phase 2a proof-of-concept clinical trials of GH001 for the treatment of new conditions: patients with bipolar II disorder and a current depressive episode.
Clearmind Medicine Announces Additional Positive Pre-Clinical Results for its Cocaine Addiction Treatment
“We are very excited by these new results which further strengthen our previous results indicating the potential of our proprietary MEAI to treat cocaine addiction,” said Dr. Adi Zuloff-Shani, Clearmind’s Chief Executive Officer. “…The results, even in this preliminary stage, also show the business impact as we need new and effective therapeutics, and these hold high commercial potential.”
This pattern of results aligns with a previous Clearmind study which tested the conditioned place-preference paradigm, where similar sub-population group was identified in the context of cocaine preference. This research demonstrates again MEAI’s unique ability to treat cocaine addiction and its potential to become the first dedicated cocaine addiction treatment.
Seelos Therapeutics Receives a Research and Development Grant from The Michael J. Fox Foundation for Parkinson’s Research for SLS-004
Seelos announced it was selected to receive a grant from The Michael J. Fox Foundation for Parkinson’s Research to advance preclinical research and development of its gene therapy delivered SLS-004 program.
“The selection of SLS-004 to receive grant funding from The Michael J. Fox Foundation is a strong validation of our program and should significantly raise the profile of our program,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We look forward to sharing additional data from our ongoing preclinical studies later this year.”
