Drug Development News
This week in psychedelic business news, PharmaDrug Inc. entered into a research agreement with the Terasaki Institute to develop a novel ocular drug delivery platform. The goal is to use the platform to deliver psychedelic and tryptamine-based pharmaceuticals including N, N-dimethyltryptamine (DMT) to treat eye diseases, including glaucoma.
“We are very excited to partner with the Terasaki Institute, a leader in the design and development of novel drug delivery technologies. This relationship will expedite our development plan and move us meaningfully closer to our goal of evaluating DMT and other tryptamines for various types of eye disease which require both a pharmacological and delivery solution to fill the significant treatment gap in glaucoma,” says Daniel Cohen, Chairman and CEO of PharmaDrug. “By aligning ourselves with thought leaders in the space we aim to tackle the worthy challenge of developing a novel delivery device that will provide sub-psychedelic quantities of candidate tryptamines to the front of the eye.”
The scientific team of Core One Labs Inc.’s subsidiary Akome Biotech Ltd., is taking the first step toward designing its clinical develop plans for using Core One’s patent-pending psychedelic formulations AKO001 and AKO003 for the treatment of ischemic stroke and depression, respectively.
As part of this process, Core One is completing a comprehensive search and rigorous selection process through which multiple commercial research organizations and academic centers are vetted to determine a candidate organization to conduct the necessary in vitro and in vivo studies. Once a partner organization is chosen for both the in vivo and in vitro processes, studies can be conducted simultaneously to expedite the process.
“We are excited to announce we have started the process of moving forward in the next step of our clinical trials development for our stroke treatment drug formulation and our depression treatment drug formulation. Identifying a partner with experience, and knowledge of the targeted diseases, will allow Core One to efficiently complete well thought out, and detailed studies,” says Joel Shacker, Core One’s CEO.
Clinical Trials
On the clinical trial side of the psychedelic business, Tryp Therapeutics inked a deal with Calvert Labs to design and execute exploratory studies into Tryp’s Psilocybin-for-Neuropsychiatric Disorders program. The studies will focus on generating toxicology and blood exposure level data for Tryp’s proprietary, psilocybin-based formulation called TRP-8803, and will provide regulatory support for Tryp’s novel methods for the formulation, delivery, and dosing of its products for clinical trials moving forward.
Tryp will also work with Calvert Labs’ parent company Altasciences to perform clinical pharmacology studies in healthy volunteers using TRP-8803 ahead of planned Phase 2b clinical trials investigating the compound for the treatment of chronic pain and eating disorders.
Incannex Healthcare completed a Human Research Ethics Committee submission to launch a Phase 2a Psi-GAD study which combines psilocybin with psychotherapy to treat patients with generalized anxiety disorder (GAD).
The randomized triple-blind, active-placebo-controlled trial will involve 72 participants who will undergo two psilocybin or placebo dosing sessions and up to 11 non-drug, psychotherapy sessions over a 10-week period. The study will be conducted by Monash’s School of Psychological Sciences and the Department of Psychiatry at BrankPark a neuroscience research platform within the university’s Turner Institute for Brain and Mental Health.
Incannex is also working with regulatory specialist Camargo Pharmaceuticals to gather information needed in order to request a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA).
