Psyched: MindMed To Begin Mescaline Trials and Deepak Chopra Partnership, Seelos And Cybin Advance Clinical Research

MindMed’s News Spree: Mescaline Trials, Chopra Foundation Partnership and LSD Research

MindMed MNMD MMED released a series of new announcements following the company’s Q1 earnings report.

The company reported Thursday that it had obtained authorization from one of the local Swiss ethics committees to conduct its first clinical trial on mescaline.

The research is scheduled to begin in May at the University Hospital Basel Liechti Lab in Basel, Switzerland.

The study will examine the effects of various doses of mescaline and “the role of the serotonin 5-HT2A receptor in a mescaline-induced altered state of consciousness.”

MindMed noted that the importance of this study lies in the fact that valid studies on the effects of different doses of mescaline, including placebo, are few and far between. The company will also gather data from the trial and create a foundation for future clinical trials on the medical potential of mescaline.

“This study will, we believe, provide the first modern research data on mescaline regarding dosing and mechanism of action in humans,” said Dr. Matthias Liechti, Ph.D., M.D. and professor of clinical pharmacology and internal medicine at the University of Basel.

The company also announced it had signed a new letter of intent to partner with The Chopra Foundation, a nonprofit led by spiritual author Deepak Chopra, with the goal of raising public awareness about the use of psychedelic medicines.

The two organizations are planning a research partnership in which they will investigate the benefits of altered states of consciousness, psychedelic psychotherapy and their overall impact on mental wellbeing.

Finally, MindMed shared an update on its launch of a Phase 2b clinical trial on LSD for generalized anxiety disorder, stating it had received positive feedback from the FDA on recent pre-Investigational new drug (IND) meetings. The company expects to submit its IND application in the third quarter of 2021.

Seelos Shows Positive Results On Ketamine Nasal Spray

Seelos Therapeutics, Inc. SEEL announced it achieved positive results in a Phase 2 proof-of-concept study of intranasal ketamine in the treatment of acute suicidal ideation and behavior in patients with major depressive disorder.

The study used SLS-002, an intranasal formulation of ketamine, on 17 subjects whose depression required psychiatric hospitalization due to significant risk of suicide. SLS-002 was well tolerated, with 47% of patients having at least one adverse event, mild or moderate in nature, most commonly involving headaches, dizziness or feeling abnormal.

"Rapid and clinically meaningful efficacy both as an anti-depressive and anti-suicidal therapeutic after a single dose could make SLS-002 an ideal therapy for this large unmet need of acute suicidality in major depression," said Raj Mehra, Ph.D., chairman and CEO of Seelos.

The company also announced a new $60 million public offering, issuing approximately 19 million shares of its common stock, at a price to the public of $3.10 per share.

At the time of this writing, Seelos stock was $3.26 per share.

Cybin Moves Forward With Clinical Trial On Psilocybin Oral Film

Cybin Inc. CYBN CLXPF, announced it had received initial clearance to begin a Phase IIa clinical trial on psilocybin for patients suffering from major depressive disorder.

The head-to-head study will test Cybin’s proprietary sublingual psilocybin formulation against a 25mg psilocybin capsule on 40 patients.

The trial has been approved by a review board at the University of the West Indies in Jamaica, where the research will be undertaken. The company still awaits final confirmation by Jamaica’s Ministry of Health to begin testing the product on human subjects.

Cybin’s psilocybin oral dissolving film product, developed via a partnership with IntelGenx Corp. IGX IGXT, is expected to deliver faster absorption of psilocybin into the bloodstream. The trial aims to prove the benefits of this method, which is also expected to deliver a shorter duration of action and a lower effective dose.

The company announced it is filing for a new patent related to novel compounds, also expected to have improved pharmacokinetic profiles while retaining key efficacy measures of the original molecules. The patent will include methods for the application of these molecules.

The Milestone Round

• Awakn Life Sciences announced a reverse take-over (RTO) transaction with 1169082 B.C. Ltd., that will result in the company’s stock going public on the NEO stock exchange in the near future. Regarding the RTO, the company announced a CA$8 Million ($6.62 million) financing round. The listing date, dependent on the successful execution of the transaction, has not been confirmed. 
• PharmaTher Holdings Ltd. PHRM PHRRF announced that the FDA has granted approval for a new phase II clinical trial using ketamine for the treatment of Parkinson’s disease. The company will begin enrolling patients in the third quarter of this year to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's.