- Global Wellness Strategies Inc. (GWS) and iNGENü sign an agreement with PharmAla Biotech (MDMA) to supply GMP MDMA for an upcoming clinical trial
- The clinical study will gauge pain thresholds in subjects who have been pre-emptively treated with MDMA
- The Good Manufacturing Practices (GMP) MDMA being supplied is required for phase three studies in the U.S. and the European Union
- PharmAla is the first North American company to produce it
- PharmAla Biotech (MDMA) is unchanged trading at $0.06 per share as of 9:12 a.m. EST
- Global Wellness Strategies Inc. (GWS) is unchanged trading at $0.26 per share as of 9:31 a.m. EST
Global Wellness Strategies (GWS) and iNGENü have signed an agreement with PharmAla Biotech (MDMA).
Under the terms of the agreement, PharAla will supply Good Manufacturing Practices (GMP) MDMA for an upcoming clinical trial.
The clinical study will gauge the effect size of an increase in the pain threshold in subjects who have been pre-emptively treated with MDMA.
iNGENü was chosen as the contract research organization (CRO), as it specializes in novel psychedelic clinical trials.
Meris Kott, CEO of Global Wellness Strategies commented on the agreement.
“Biotechs face many roadblocks as a drug development journey begins. Developing an integrated, big-picture roadmap for a molecule and company can only work with a formidable CRO, as even a lucrative discovery is a challenging and expensive endeavor.”
iNGEnü will guide the research and trials and PharmAla will complete the MDMA supply orders.
PharmAla is the first company in North America to develop a full GMP MDMA value chain.
The GMP MDMA uses a set of conditions to manufacture the drug which is required for phase three studies in the U.S. and the European Union.
Global Wellness’ subsidiary, Shanti Therapeutics, uses a technology that acts directly on nerves by using the properties of MDMA to treat preoperative pain.
Shanti is setting up its clinical trial with 22 healthy volunteers to compare pain tolerance threshold in those who have had exposure to a dose of the GMP MDMA.
PharmAla Biotech (MDMA) is unchanged trading at $0.06 per share as of 9:12 a.m. EST.
Global Wellness Strategies Inc. (GWS) is unchanged trading at $0.26 per share as of 9:31 a.m. EST.