Psyched: MindMed's MDMA Program For Autism, Small Pharma's New Patent, NovaMentis' Orphan Drug Designation

The Week In Psychedelics:

1. MindMed Launches MDMA Program For Social Anxiety And Autism
2. FDA Green Lights IND Application For A Brain Study On Ketamine’s Effects
3. Toronto’s University Health Network Gets $4 Million Donation For A Psychedelics Research Center
4. Nova Mentis Receives Orphan Drug Designation In The EU For Fragile X Syndrome
5. Small Pharma Receives Patent For Ketamine-Based Compounds For Depression
6. Psychedelic Music Studio Closes $4.5M Seed Round
7. Delic Teams Up With Biotech Co. GT Research
8. The Milestone Round

MindMed Launches MDMA Program For Social Anxiety And Autism

Mind Medicine Inc. MNMD, announced on Tuesday a new program meant to deploy MDMA for the treatment of social anxiety in diagnoses that include autism spectrum disorder.

Social anxiety and impairments in social functioning are hallmarks of ASD, which occurs in approximately 2% of individuals in the U.S.

“At present, there are no approved therapies for the core symptoms of ASD and there remains a significant unmet need for novel therapies to support people with ASD,” said MindMed in a press release.

A phase 2 pilot safety study of MDMA-assisted therapy for social anxiety in autistic adults by MAPS showed strong and statistically significant improvements in social anxiety and functioning from short-term treatment with MDMA.

MindMed plans to advance an R(-)-MDMA development program targeting US and EU registration and expects to initiate its first clinical trials in 2022. 

FDA Green Lights IND Application For A Brain Study On Ketamine’s Effects

The FDA has authorized an Investigational New Drug application from Cybin Inc. CYBN for a study that will use Kernel’s Flow to measure ketamine’s psychedelic effect on the brain, an area of ketamine therapy that is still under debate.

Kernel Flow is a non-invasive helmet-like brain scanning device. Cybin partnered with Kernel earlier this year to explore the device’s potential in psychedelics research.

Kernel Flow enables the acquisition of brain activity before, during and after a psychedelic experience, providing quantification of what was previously left to subjective patient reporting.

“The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’ (the ability to dynamically trace the neural correlates of human conscious experience). Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens,” said Dr. Alex Belser, Cybin’s chief clinical officer.

“This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” Belser added.

Toronto’s University Health Network Receives $4 Million Donation For Psychedelics Research Center

Toronto’s University Health Network received a CA$5 million ($4 million) donation from Canadian tech entrepreneur and venture capitalist Sanjay Singhal through the Nikean Foundation, a nonprofit founded by Singhal.

The donation launched the Nikean Psychedelic Psychotherapy Research Centre within the Centre for Mental Health at UHN, with plans to “harness the potential of psychedelic medicine to provide transformative care to patients, pioneer training in psychedelic psychotherapy and conduct high-quality research that advances the field,” as per a release by the UHN.

CTVNews reported that Singhal suffered from bipolar disorder, which improved substantially after treatment with psilocybin and 5-MeO-DMT.

As these medicines become available, clinicians at the Nikean Psychedelic Psychotherapy Research Centre plan to begin treating patients with them.

"The Centre for Mental Health at UHN is a leader in treating complex patients with comorbid mental and physical illnesses," said Dr. Susan Abbey, inaugural director of the Nikean Psychedelic Psychotherapy Research Centre and psychiatrist-in-chief at UHN.

Nova Mentis Receives Orphan Drug Designation In The EU For Fragile X Syndrome

Nova Mentis Life Science Corp. NOVA NMLSF recently announced a partnership with Mycrodose Therapeutics to develop patented psilocybin products to treat neuroinflammatory disorders with autism in mind.

The partnership will explore the use of psilocybin-based therapeutics in disorders like fragile X syndrome and autism spectrum disorder, by using Mycrodose’s patented drug delivery systems with Nova Mentis's proprietary version of psilocybin.

Fragile X syndrome is a genetic condition that causes a variety of developmental problems including learning disabilities and cognitive impairment often associated with autism. One in three individuals with fragile X syndrome presents features related to autism spectrum disorder.

The companies recently announced having received orphan drug designation from the European Medicines Agency (EMA), a status granted to certain compounds that have the ability to treat rare and genetic conditions with unmet solutions, affecting relatively small populations. The designation helps pharmaceutical companies waive fees, receive tax credits and fast-track the development of the drug.

The companies have also applied for the orphan drug designation from the FDA.

Small Pharma Receives Patent For Ketamine-Based Compounds For Depression

Small Pharma Inc. DMT DMTFF has received a European patent that grants protections for certain oral dosage of 6-HNK, an active ketamine metabolite, including the company’s preclinical candidate SPL801B, for use in the treatment of depressive disorders.

"Securing the patent rights to SPL801B, our preclinical ketamine-based candidate for the treatment of depression, allows us to securely investigate its commercial potential,” said Peter Rands, CEO of Small Pharma.

Early preclinical studies of SPL801B have shown signs of potential antidepressant outcomes without the psychoactive effects typically associated with ketamine, according to Small Pharma.

Psychedelic Music Studio Closes $4.5M Seed Round

Wavepaths, a music studio dedicated to the creation of music to accompany psychedelic therapy, closed a $4.5 million seed investment round.

The company, co-founded by Dr. Mendel Kaelen and Anna Rickman in 2019, is described as “a digital platform that builds upon pioneering scientific research showing that music plays an essential role in creating positive outcomes for psychedelic therapies.”

The platform offers customizable music that can be used to benefit the therapeutic outcomes of “trips” with ketamine, psilocybin and MDMA, among other similar drugs.

The company stated in a press release that it has worked with a variety of musical artists to create an AI-powered auditory landscape designed to be responsive to every moment of a therapy session.

“During sessions, the platform’s interface allows practitioners to seamlessly transition between emotional atmospheres, levels of depth and activation, and instrumentation in real time, based on a patient’s evolving mood or therapeutic needs,” noted the company.

Delic Teams Up With Biotech Co. GT Research

Delic Holding Corp Inc. DELCF 6X confirmed Tuesday it has teamed up with GT Research Inc. a biotech company focused on the cannabis and psychedelics industries. 

Under the deal, Delic Labs, a subsidiary of Delic, will offer genetic analysis of psychedelic mushrooms and cannabis to Canadian producers, including detailed analyses of specific areas of the genome relating to traits of commercial interest. 

Delic Labs is a federally-authorized psilocybin and cannabis research laboratory focused on extraction, analytical testing and chemical process development. 

The analytical services under the new deal will include sample preparation, DNA extraction, whole-genome sequencing, computational analysis and reporting.

"Partnering with GTR will give us the most comprehensive genomic insights in the industry and build on our efforts to provide the highest standards and quality control for psychedelic and cannabis compounds," said Dr. Marcus Roggen, co-founder of Delic Labs.

The Milestone Round

• Clearmind Medicine Inc. CMND CWY has entered into a development and supply agreement with Aragen Life Sciences Pvt. Ltd for the production of 5-Methoxy-2-aminoindane, a “unique synthetic, psychedelic molecule that simulates the euphoric alcohol experience while simultaneously reducing the desire to consume alcohol.”

Clearmind is now in the process of preparing for a pre-investigational new drug meeting with FDA staff, which will be followed by an IND application and possible clinical trial in the second half of 2022.

• Beckley Psytech announced that the first cohort of volunteers has been dosed in its Phase 1 study to evaluate the safety and tolerability of a single intranasal dose of 5-MeO-DMT in psychedelic-naïve healthy subjects. 
• Mind Cure Health Inc. MCUR MCURF has signed a non-binding letter of intent with Awakn Life Sciences AWKN AWKNF to become a distributor of Awakn’s ketamine-assisted psychotherapy for alcohol use disorder protocol in the US and Canada.