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.
Mydecine Closes Capital Raise
Mydecine announced the closing of a larger capital raise — issuing 2,447,130 shares at a price of $1.15, for aggregate gross proceeds of $2,814,199.50 (this was the closing of their previously announced offering of up to $4 million).
This is nearly $3 million in much-needed capital, and should help solidify things while they get their developmental projects underway, including promising Phase 2 trial for smoking cessation with Johns Hopkins.
Small Pharma Shares Business Update Ahead of Annual Financial Results
Small Pharma has announced a business update ahead of its annual financial results for the fiscal year ended February 28, 2022. Full results will be presented in June 2022. Highlights include:
– Appointment of Alastair Riddell as COO
– Two new Composition of Matter patents granted for pipeline projects
– The Phase IIa clinical trial is progressing well as the Company enters the latter stages, with a significant number of patients dosed and no safety concerns highlighted to-date. Phase IIb clinical trial preparation continues.
Ceruvia Lifesciences Working on Phase 2 Psilocybin Trial for OCD
Based on a positive pre-IND meeting with the U.S. Food and Drug Administration (FDA), Ceruvia Lifesciences has submitted an Investigation New Drug (IND) application to begin a Phase 2 clinical trial for the treatment of obsessive-compulsive disorder with psilocybin.
Preliminary results from the Ceruvia funded pilot Phase 2 study taking place at Yale School of Medicine demonstrate rapid and robust improvement in OCD symptoms with a sustained effect.
Clearmind Announces Successful Pre-IND Meeting with U.S. FDA for CMND-100 for Alcohol Use Disorder
“The FDA’s interest in CMND-100 as a potential therapy for alcohol use disorder was extremely encouraging,” said Dr. Adi Zuloff-Shani, Clearmind’s CEO. “Their feedback to the proposed development program was positive, and we are working diligently towards initiating the clinical trials with CMND-100 by the end of 2022.”
Biomind Labs Receives Approval for a Third Phase II Clinical Trial for Its 5-MeO-DMT Based BMND08 Candidate for Treatment of Depression and Anxiety in Alzheimer’s Disease
The company announced that a third Phase II clinical trial for its BMND08 candidate based on 5-Methoxy-N,N-dimethyltryptamine (“5-MeO-DMT”) for treatment of depression and anxiety in patients with Alzheimer’s-type cognitive impairment has been approved by the Argentinian Institutional Review Board.
“As we continue to move forward with our efforts in identifying indications where we can provide significant improvement in patients suffering from mental health, we are more than pleased to announce the approval of a Phase II clinical trial for our BMND08 novel drug candidate which may allow us to address a new line of development to attenuate depression and anxiety states in patients with Alzheimer’s-type cognitive impairment,” commented Alejandro Antalich, CEO of Biomind Labs.
Braxia Scientific Receives Health Canada Special Access Program Approval to Provide Psilocybin-Assisted Therapy for Depression in Ontario
Health Canada approval is for a patient with the indication of Major Depressive Disorder, in the absence of terminal medical illness or end of life distress. The approval marks Braxia’s first Special Access Program (SAP) approval for use of psilocybin in Ontario. To date Braxia’s experienced therapists have delivered psilocybin-assisted therapy treatments to 16 individuals with depression through its proprietary clinical trial commenced late 2021.
