Canadian company PharmAla Biotech has filed a key patent cooperation treaty (PCT) application, containing six novel chemical entities (NCEs).
The application claims priority to, and benefit of a United States provisional patent application filed August 20, 2021. The PCT application disclosed novel compositions of MDMA and analogs that may be used to alleviate the known side effects of MDMA while retaining its efficacy.
Building on preclinical animal studies completed at the University of Arkansas School for Medical Sciences (UAMS), PharmAla said it has developed evidence of the improved safety pharmacology of its ALA series of MDMA analogs.
This includes evidence of diminishing hyperthermia and neuro- and cardio-toxicity, while retaining its therapeutic effects. The ALA series is composed of three distinct NCEs, although PharmAla expects to bring only one of these molecules to IND status at this time.
“MDMA is a fascinating molecule with a troubled history. The therapeutic potential of this compound has been obvious since its earliest days, but its potential for abuse and adverse effects has been just as noteworthy,” said William Fantegrossi, principal investigator for PharmAla Biotech at UAMS.
“The work being done at PharmAla to create formulations which retain therapeutic efficacy while minimizing harm is incredibly important to the future of MDMA as a medicinal agent, and the drug development strategy their work exemplified through this patent is a model for the field of ‘psychedelic medicine’ as a whole.”
Non-controlled subject status
PharmAla’s research into its ABA series of molecules, which are comprised of an MDMA analog not currently listed as a controlled substance in Canada, is also contained within the patent filing. PharmAla expects to bring one of its three ABA NCEs to trial in an ex-USA jurisdiction, where its status as a non-controlled substance will allow for faster and more cost-effective research.
“Addressing the toxicology of generic MDMA with the aid of novel compositions and new drug molecules has been the primary focus of our work. This patent application reinforces our position in the industry as the pioneers of MDMA development. Considering we’re the only public company to have manufactured GMP MDMA, that’s only fitting,” said Harpreet Kaur, vice president of research at PharmAla Biotech.
“There is a serious unmet need for patients with mental health challenges. Psychedelics continue to demonstrate their benefits through multiple clinical trials. However, as a ‘regulatory first’ company, we know that both regulators and the general public demand exemplary safety from pharmaceutical products such as MDMA; This patent represents our first step to meeting that high bar.”