PharmAla Biotech (CSE: MDMA) has now made more progress on its quest to become an industry leader and promote MDMA therapy.
On Monday, the Canadian biotechnology company announced that it filed a Patent Cooperation Treaty (PCT) application for six Novel Chemical Entities (NCEs).
Those NCEs include a series of novel compositions of MDMA intended to alleviate side effects associated with the regular form of the drug while maintaining the same level of efficacy for treating mental health conditions.
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PharmAla is a biotechnology company with a professional team consisting of scientists, regulatory experts and biomanufacturing specialists. The organization focuses on the development of clinical-grade MDMA and NCEs.
The PCT application now filed by the company is an international application applicable in 153 countries around the globe and administered by the World Intellectual Property Organization (WIPO), according to the Government of Canada.
The company says that following pre-clinical studies conducted on animals at the University of Arkansas School for Medical Sciences (UAMS), its “ALA” series of MDMA analogs have shown improved safety pharmacology in comparison to standard MDMA. Significantly lowered levels of neuro-toxicity, hyperthermia and cardio-toxicity along with a maintained level of therapeutic value are characteristics of the analogs, according to PharmAla.
The ALA series is comprised of three unique NCEs, but the company currently only plans on bringing one of those molecules to Investigational New Drug (IND) status.
“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 Dr. 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,” added Dr. Fantegrossi.
The patent filing by PharmAla will additionally contain the company’s ABA series of molecules, which the biotechnology outfit says are comprised of an MDMA analog not currently classified as a controlled substance in Canada. The company also says that it will be bringing one of its three ABA NCEs to trial in an “ex-USA jurisdiction” where PharmAla will benefit from its status as a non-controlled substance allowing speedier, more economically efficient 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 Dr. 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,” added Dr. Kaur.
