Psyched: Delic Buys 10 Ketamine Clinics For $10M, Atai Launches Ibogaine Human Trials, Small Pharma Concludes Phase 1 DMT Study

The Week In Psychedelics:

1. Delic Signs $10 Million Merger With Chain Of Ketamine Clinics
2. Atai Subsidiary DemeRx Launches Phase 1/2a Clinical Trial On Ibogaine
3. Small Pharma Completes Phase 1 Trial on DTM For Depression, Moves to Phase 2a
4. MindMed and Liechti Lab Release Research Results On LSD, Psilocybin And SSRIs
5. Awakn Buys Rights To MDMA In Alcoholism Study
6. Seattle Could Soon Decriminalize Natural Psychedelics
7. The Milestone Round

Delic Signs $10 Million Merger With Chain Of Ketamine Clinics

Delic Holdings Corp.DELC DELCF has entered into a binding merger agreement with Ketamine Wellness Centers Arizona LLC, a company operating 10 ketamine infusion treatment clinics across the country.

The $10 million transaction will involve $5 million in cash and another $5 million to be paid in Delic shares.

Ketamine Wellness Centers has locations in Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas and Washington. The company has overseen an aggregate of 60,000 treatments to date.

According to the companies, Ketamine Wellness Centers has been operating profitably with 2020 revenues in excess of $3.5 million.

The clinics will be added to Delic’s assets, which already include two ketamine therapy clinics.

"We have been fortunate to earn the trust of a diverse patient base as the largest chain of clinics in the country and were looking for a partner that could help scale our efforts to reach the greatest number of those who can benefit from psychedelic wellness treatments,” said Kevin Nicholson, CEO of Ketamine Wellness Centers.

Atai Subsidiary DemeRx Launches Phase 1/2a Clinical Trial On Ibogaine

DemeRx IB, Inc, a subsidiary of Atai Life Sciences ATAI, has begun a phase 1/2a clinical trial of ibogaine on healthy volunteers and recreational drug users.

The trial is expected to shed light on ibogaine’s ability to treat opioid addiction, a malady affecting at least one million Americans each year.

“The CDC tallied 93,000 drug overdose deaths in 2020, 70,000 of which involved opioids,” said Srinivas Rao, chief scientific officer of Atai Life Sciences.

The company announced on Tuesday that the initial subjects of the trial had received their first doses of DMX-1002, the company’s proprietary oral formulation of ibogaine at the Manchester clinical unit of MAC Clinical Research in the UK.

The trial is expected to assess safety, tolerability, pharmacokinetics and efficacy of the drug. 

The company expects to obtain safety data from the first segment of the study by early 2022. 

Small Pharma Completes Phase 1 Trial on DTM For Depression, Moves to Phase 2a

Small Pharma Inc. DMT has completed the phase I part of a combined Phase I/IIa clinical trial of its lead candidate, SPL026, for the treatment of major depressive disorder. 

With this achievement, the company has moved to the Phase 2a part of the study.

SPL026 is a proprietary intravenous formulation of DMT. The formulation “was very well tolerated in individuals with no previous experience of psychedelics,” said the company.

SPL026 was administered in combination with supportive psychotherapy to 32 healthy psychedelic-naïve volunteers and demonstrated “a favorable safety profile with no serious adverse events.”

Pharmacokinetics data from the Phase 1 study has allowed the company to settle on a dose of SPL026 that can occasion a breakthrough psychedelic experience and is also safe and well-tolerated.

The company is now using this dosage in a Phase 2a study of SPL026 in combination with psychotherapy in 42 patients with major depression. Topline results are anticipated in the first half of 2022.

MindMed and Liechti Lab Release Research Results On LSD, Psilocybin And SSRIs

Mind Medicine Inc. MNMD MMED, also known as MindMed, has released results from investigator-initiated studies being conducted as part of its ongoing collaboration with the UHB Liechti Lab in Switzerland.

Comparing the effects of LSD and psilocybin, the lab’s research shows that the perceptual effects of a dose of 100 micrograms of LSD were found to be equivalent to a dose of 20 milligrams of psilocybin in healthy volunteers.

Psilocybin was also found to be safe to administer together with an SSRI antidepressant. The organizations wrote that daily pre-treatment with escitalopram (a common antidepressant) for two weeks prior to psilocybin administration reduced anxiety and blood pressure increases associated with psilocybin but did not reduce the acute psychedelic experience.

"It is important for us to understand the acute effect characteristics of different psychedelics, and to understand how these substances interact with other treatments like antidepressants,” said Dr. Liechti. 

Awakn Buys Rights To MDMA In Alcoholism Study

Awakn Life Sciences Corp. AWKN AWKNF has acquired exclusive rights to data from a phase 2a MDMA in alcoholism study from the Imperial College London.

The open-label, safety, tolerability and proof-of-concept study looked into the role of MDMA-assisted psychotherapy in treating patients with alcohol use disorder, which is one of the main indications Awakn is after in its research programs. 

The results, which were published in February 2021, indicated that MDMA has the potential to obtain a 20% relapse rate within the first nine months, compared to a 75% relapse rate with traditional treatments.  

The company now plans to move into a phase 2b randomized controlled trial on the same indication.

Seattle Could Soon Decriminalize Natural Psychedelics

Seattle, Washington could soon become the next jurisdiction to decriminalize the personal use and possession of psychedelic substances, following the path of several cities including Ann Arbor, Oakland and Washington D.C.

Marijuana Moment reported that a Seattle City Council committee heard comments from supporters of a resolution that would make the use of natural psychedelics like psilocybin mushrooms, ayahuasca, iboga and mescaline “in religious, spiritual, healing, or personal growth practices,” among the lowest law enforcement priorities.

The resolution would decriminalize “a wide range of activities around psychedelic drugs, including cultivation and sharing with others.”

Councilmember Andrew Lewis and the advocacy group Decriminalize Nature Seattle shared their comments with the council. The Decriminalize Nature movement is behind the successful decriminalization of psychedelics in over eight jurisdictions around the country.

According to Marijuana Moment, Councilmember Lisa Herbold, who chairs the committee, said the full City Council will likely take up the measure in the coming weeks.

The Milestone Round

KetamineOne Capital Limited MEDI KONEF has signed a non-binding letter of interest with Veteran Services USA to lease approximately 5,000 square feet of space over an initial term of five years in Blue Island, Illinois, where the company plans to create “a first-of-its-kind healing experience specifically for veterans suffering from post-traumatic stress disorder.”

PsyBio Therapeutics Corp. PSYB PSYBF, a company producing psilocybin and other tryptamines in genetically modified bacteria, submitted its first pre-Investigational New Drug application meeting request to the FDA.

Havn Life Sciences Inc. HAVNHAVLF announced a partnership with California-based Mycrodose Therapeutics for the supply of Havn’s naturally-derived psilocybin. Mycrodose has been granted a Schedule I License by the DEA to research psilocybin, MDMA, DMT and LSD.

Beckley Psytech announced that the first patient in its clinical trial exploring the effects of psilocybin for treating short-lasting unilateral neuralgiform headache attacks has been dosed. Data from this study is expected in early 2022.

Numinus Wellness Inc. NUMI, has closed its acquisition of the Neurology Centre of Toronto, a Canadian provider of clinical neurologic care for CA$300,000 ($237,000) plus CA$200,000 in Numinus stock.

Clearmind Medicine Inc. CMND has established a research and development project with Yissum Research Development Company, the technology transfer company of The Hebrew University of Jerusalem. The collaboration will focus on developing novel, innovative, patentable psychedelics as potential drug candidates to expand Clearmind’s IP portfolio.