Psyched: Groundbreaking Phase 3 Results On MDMA, Small Pharma, Wesana Go Public, Gilgamesh Raises $27M

Last week, the psychedelics space was moved by results from the world’s first Phase 3 clinical study of a scheduled psychedelic compound.

The Multidisciplinary Association for Psychedelic Studies released the results from its Phase 3 trial on MDMA for the treatment of post-traumatic stress disorder. 

The randomized, blinded, Phase 3 trial enrolled 90 patients with severe chronic PTSD who were divided into two groups. 

The first group of 46 participants received three sessions of MDMA-assisted talk therapy, while the control group of 44 people received a placebo as well as the same talk therapy.

Results were measured after 18 weeks. Sixty-seven percent of participants in the MDMA-assisted therapy group no longer qualified for a PTSD diagnosis after the MDMA-assisted therapy sessions versus 32% in the placebo group.

Eighty-eight percent of participants from the MDMA group experienced a clinically significant reduction in symptoms versus 60% in the control group.

MDMA could be offered to patients legally across the country by 2023, or even 2022, as a MAPS spokesperson told Benzinga in a recent interview.

Small Pharma, Wesana Health Go Public

Small Pharma Inc. announced the listing of its stock on the TSX Venture Exchange under the symbol “DMT” after the completion of a reverse takeover.

The stock went live on the exchange on May 6.

In March, the company closed a CA$58-million ($47.8 million) raise to fund go-public operations and R&D.

The London-based biotech is working on studying the psychedelic DMT for the treatment of depression in a Phase I/IIa trial clinical trial that launched in February.

Wesana Health Inc., a company led by former professional ice hockey player Daniel Carcillo, announced the successful closing of a reverse takeover, leading to the listing of the stock on the Canadian Securities Exchange Monday under the symbol “WESA.”

Wesana is focused on using psychedelics and natural medicines to treat the symptoms of traumatic brain injury, a condition often suffered by professional sports players, army veterans and victims of abuse.

The company is developing a proprietary formulation of psilocybin for this condition and aims to fund clinical research of its formulation for the treatment of TBI. 

In late March, Wesana closed a CA$16.1-million raise.

Novamind, Field Trip Expand Footprint Of Psychedelic Clinics

Novamind Inc. NVMDF announced Tuesday it intends to open four new psychiatry clinics in Utah.

The clinics, operating under the Cedar Psychiatry brand, are expected to increase the company’s patient volume by 225% in 2021, according to its own estimates.

Novamind decided to scale up its existing footprint upon seeing a substantial increase in demand at its four Utah locations. The new clinics are scheduled to open between July and September of 2021.

“In 2019 we saw 10,000 patient visits, in 2020 there were 20,000, and now we’re expecting 65,000 within this calendar year,”  CEO Yaron Conforti told Benzinga. 

The company has started construction on three sites and has leased a fourth property.

Field Trip Health Ltd. FTRP FTRPF announced its fifth clinic location in the country, with an opening in Houston, Texas adding to the company’s presence in New York, Chicago, Los Angeles and Atlanta.

The company also announced plans to set up shop in the California cities of San Diego and San Carlos as well as Seattle, Washington D.C. and Fredericton, Canada.

Field Trip said it has entered into leases in these locations and has already, or will soon, begin construction.

Field Trip CEO Ronan Levy previously told Benzinga the company plans to be operating a minimum of 75 new clinics in North America by 2024.

Gilgamesh Pharmaceuticals Raises $27M In Series A

Gilgamesh Pharmaceuticals reported Thursday it has raised $27 million in a Series A funding round led by Prime Movers Lab.

With the newly raised capital, New York-based Gilgamesh plans to add more members to its team, including a COO, head of R&D and CBO. It will also work on advancing its programs toward clinical candidate selection and broadening its IP portfolio.

Texas Bill To Research Psychedelics Passes House Vote

A bill that aims to promote research on the therapeutic potential of psychedelic substances was approved by the Texas House of Representatives.

The bill, introduced in February by Rep. Alex Dominguez, would direct the Department of State Health Services and the Texas Medical Board to study psilocybin, MDMA and ketamine in the treatment of post-traumatic stress disorder.

The bill passed by a vote of 134-12 and will now head for Senate vote.

The Milestone Round

• MindMed MNMD announced the launch of a project set to research LSD and other psychedelics for the treatment of pain conditions.

The company plans to submit an application with the FDA to begin a Phase 2a proof-of-concept study in the second half of this year.

• Champignon Brands Inc. SHRM SHRMF, a company that recently resumed trading of its stock after months under a cease trade order imposed by the British Columbia Securities Commission, announced it has changed its name to "Braxia Scientific Corp.,” with its ticker symbol also changing to "BRAX” on the CSE and BRAXF on the OTC market.
• Havn Life Sciences Inc. HAVN HAVLF announced its mycology lab and production facility in Jamaica is now fully operational. The company plans to use the site to develop an optimized growing criteria for psilocybe mushrooms and other R&D efforts.
• Core One Labs Inc. COOL CLABF announced the successful purchase of Akome Biotech Ltd., a company that holds four provisional composition of matter patents filed with the USPTO for plant bioactive-psychedelic drug formulations.

Akome’s formulations include the use of DMT to target Parkinson’s disease and ischemic stroke; the use of psilocybin for addressing Alzheimer’s disease; and a ketamine-based formulation for depression.