Welcome to the News You Might Have Missed, a weekly roundup of psychedelic medicine headlines to help you catch up and stay informed. It was a busy week with lots of news, have a look and see you next week for another update.
Algernon Pharmaceuticals Receives Approval for Groundbreaking Phase 1 DMT Human Stroke Study
Algernon has received approval to conduct a Phase 1 clinical study of an intravenous formulation (“IVF”) of AP-188 (“N,N-dimethyl tryptamine” or “DMT”) for the treatment of stroke in the Netherlands. The trial will be conducted at the Centre for Human Drug Research (“CHDR”) in Leiden. The Company plans to begin screening shortly and dose the first subject of the study in Q4, 2022.
MindMed Retains its NASDAQ Listing
MindMed announces that they’ve “regained compliance with Nasdaq’s minimum bid price listing requirement…and the Company has satisfied the terms for continued listing on the Nasdaq Capital Market by complying with the minimum bid price requirement of $1.00 per share.”
PharmaTher Announces Presentation of Positive Efficacy and Safety Data from Phase 1/2 Clinical Study of Ketamine in the Treatment of Levodopa-Induced Dyskinesia in Parkinson’s Disease.
Fabio Chianelli, CEO of PharmaTher, commented: “We are pleased to see the first presentation of the data from the Phase 1/2 study of ketamine demonstrating ketamine’s safety and tolerability with clinically meaningful efficacy that supports further investigation in a proposed Phase 3 clinical study as a potential new treatment for levodopa-induced dyskinesia in Parkinson’s disease patients.
“With these data and the recent US Notice of Allowance of the patent application for ketamine in the potential treatment of Parkinson’s Disease and motor disorders, we are now focused on obtaining an agreement with the FDA to pursue approval under 505(b)(2) regulatory pathway with a potential Phase 3 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.”
Microdose Brings Psychedelics to the Concordia Summit
Microdose Psychedelic Insights is proud to announce its official partnership with the Concordia Annual Summit, presenting the first-ever Mental Health & Psychedelics Panel. The 2022 Concordia Annual Summit will convene from September 19th to September 21st in New York City. Concordia and Microdose are planning an essential conversation and reception alongside the UN General Assembly.
“I’m honored to have been able to bring Concordia and Microdose together, with the aspiration to advance a critical conversation on the regulatory reform necessary to unlock psychedelic health solutions globally,” said Isaac Gilmore, COO of Ginger Commerce and Former Navy SEAL.
Revive Therapeutics Provides Update on the Psilocybin Clinical Study for Methamphetamine Use Disorder and Oral Psilocybin Thin Film Strip Program
“We continue to focus on building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. We intend to advance the development of our oral psilocybin thin film strip product for these indications.
“In parallel, we are working on our first clinical study evaluating oral psilocybin in the treatment of methamphetamine use disorder to validate its use in substance abuse indications. The clinical data from this study will be used to support late-stage clinical trials with our oral psilocybin thin film strip product,” said Derrick Welsh, COO of Psilocin Pharma, a division of Revive.
Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History
Optimi announced that it has completed what it believes to be the largest legal natural psilocybin harvest in Canadian history. The Company is licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, as well as functional mushrooms that focus on the health and wellness markets.
“Our mushrooms are some of the most tested products on the planet as we cross the lines between Pharmaceutical, Agriculture, Botanical, and Food testing quality assays,” said Optimi Chief Science Officer, Justin Kirkland. “This yield gives us the capacity and scale we need to advance our analytical schedule while also developing our product pipeline,” he added.