Psyched: Delix Raises $30M, New Ketamine Study For Alcohol Use Disorder, FDA Approves Ketamine Trial For ALS

New Awakn Study Shows Ketamine Has Potential To Treat Alcoholism

Awakn Life Sciences Corp. AWKN AWKNF published encouraging data from a Phase II trial looking at ketamine-assisted therapy for the treatment of alcohol use disorder.

The company purchased the rights to the trial, which was led by Professor Celia Morgan, Awakn’s head of ketamine-assisted therapy for addiction and professor of psychopharmacology at the University of Exeter in the UK.

“We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post treatment abstinence rates,” Prof. Morgan said.

The double-blind placebo-controlled trial included 96 patients with severe alcohol use disorder, who were divided into different groups. Researchers used ketamine in combination with a proprietary manualized therapy protocol called “Kare,” and tested that combination against a placebo combined with regular alcohol education.

Ketamine combined with the proprietary therapy resulted in total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post-trial. The results for alcohol relapse at 6 months showed that the group receiving ketamine plus Kare therapy had a risk of relapse that was 2.7 times less than the placebo plus alcohol education group.

Delix Therapeutics Raises $30M In Convertible Note Financing, Will Enhance Drug Development Program

Delix Therapeutics announced Monday that it has raised over $30 million in convertible note financing.

According to Delix, these funds will enhance the company's ability to grow its drug development program, pipeline and platform of novel neuroplasticity-promoting therapeutics known as psychoplastogens. The company will also use these funds to expand its team and obtain the flexibility to undertake additional strategic opportunities in 2022.

Delix CEO Mark Rus said that “this latest capital raise represents the strength of investor interest, partnership, and support for Delix's approach to drug development." 

Delix has had an eventful year, having raised around $70 million in a Series A prior to this $30 million convertible note financing.

Field Trip Receives Notice Of Patent Allowance For Proprietary Psychedelic Molecule

Field Trip Health FTRP received a notice of allowance for a US patent application covering FT-104, its flagship psychedelic drug candidate.

According to the company, FT-104 is a more soluble, stable derivative form of the psychedelic molecule 4-HO-DiPT.

Field Trip’s patent claims cover the composition of matter and the use and manufacturing of a family of compounds including FT-104. The notice of allowance Field Trip received does not equal a patent granted but stands in the final track of that process.

Dr. Nathan Bryson, Field Trip’s chief science officer said FT-104 offers notable improvements over a known class of psychedelic substances. 4-HO-DiPT, the compound on which FT-104 is based, was first synthesized in 1977 and described by legendary chemist Alexander Shulgin.

Cybin Gets Approval In Canada To Conduct Brain-Imaging Study On Ketamine

A Canadian Institutional Review Board approved Cybin CYBN to advance on a company-sponsored feasibility study using Kernel Flow to measure ketamine’s psychedelic effect on the cerebral cortex.

Kernel Flow is a non-invasive helmet-like brain imaging device. Cybin will retain exclusive interest in any innovations that are discovered or developed through its independent analysis of the study's findings.

“By leveraging the Kernel Flow technology, we may have the ability to measure longitudinal brain activity before, during and after a psychedelic experience, and collect quantitative data as opposed to subjective patient reporting,” said Doug Drysdale, Cybin’s CEO.

The company received similar approval from the U.S. FDA in October 2021.

Wesana Health Gets FDA Approval For Meeting To Discuss Molecule Combining Psilocybin And CBD

The FDA granted approval to Wesana Health Holdings Inc. WSNAF for a pre-IND meeting to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of traumatic brain injury-related symptoms like major depressive disorder.

A pre-IND (Investigational New Drug) meeting is a necessary step towards the green-lighting of a clinical trial in humans.

By utilizing psilocybin and cannabidiol, SANA-013 is targeted to improve neuroplasticity and neurogenesis while acting as an anti-neuroinflammatory in the treatment of migraine and other symptoms associated with traumatic brain injury.

Ketamine One Shares Uplisted To OTCQB

KetamineOne Capital Limited KONEF announced on Wednesday that its common shares have been successfully up-listed from the OTC Pink Sheet Open Market to the OTCQB Venture Market under the symbol "KONEF.”

The OTCQB offers traders the ability to invest in entrepreneurial and development stage companies. The OTCQB companies must also prove that financial reporting is current as well as go through other verification processes. 

FDA Approves PharmaTher's Phase 2 Trial For Ketamine ALS Treatment

PharmaTher Holdings Ltd PHRRF PHRM announced on Wednesday that the U.S. FDA has accepted an application to proceed with a Phase 2 clinical trial evaluating ketamine in the treatment of Amyotrophic Lateral Sclerosis (“ALS”), also known as Lou Gehrig's disease.

“The Phase 2 clinical trial is a prospective, double-blind, randomized controlled multiple ascending dose study of ketamine, which will enroll a total of 36 participants with ALS in 3 sequential cohorts, with 12 participants in each cohort,” according to the press release.

Atai Gets Investigational New Drug Clearance for Arketamine Program

Atai Life Sciences ATAI announced that the FDA has given Investigational New Drug (IND) clearance to conduct a clinical drug-drug interaction study of PCN-101, or Arketamine.

“We see great promise in PCN-101 as a potentially rapid-acting anti-depressant with a more favorable safety and tolerability profile than S-ketamine, which could enable at-home use,” said Florian Brand, CEO and co-founder of Atai Life Sciences. “With today’s IND clearance, we are excited to continue assessing the therapeutic potential of PCN-101 in the U.S.”

The clinical study is an open-label, 2-cohort, fixed-sequence, drug-drug interaction study to evaluate the effects of CYP450 inhibition on the pharmacokinetics of PCN-101 in healthy adult subjects. Atai will use the results of this study in conjunction with clinical pharmacokinetic data to advance the development of PCN-101 in treatment-resistant depression.

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