Nova Mentis Life Science Corp., a biotechnology company and a global leader in the development of first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory diseases, and Mycrodose Therapeutics, a U.S. pharmaceutical company focused on the development of advanced drug delivery systems for the use of psychedelic substances, announce the successful milestone of merging NOVA ‘s psilocybin-based drug development program with Mycrodose’s transdermal technology.
The first human skin permeation studies are currently underway at Mycrodose Therapeutics’ laboratories in San Diego CA to prove that NOVA ‘s active ingredient can be successfully delivered through human skin using Mycrodose’s transdermal technology. The Companies believe that neuroinflammatory disorders such as Fragile X Syndrome (“FXS”), the most common inherited cause of Autism Spectrum Disorders (“ASD”), may not require a high dose of a psychedelic agent or a large macrodose of a drug for a patient to benefit therapeutically.
“This cooperative transdermal delivery technology expands the possibilities of treating chronic developmental disorders such as Fragile X Syndrome without exposing the child or adult to intolerable hallucinogenic side effects,” stated Will Rascan, NOVA’s CEO & President. “A low dose, or microdose treatment of drug using a transdermal patch is ideal because it can be monitored and changed in a home or in a clinical environment, which goes a long way to save time for our overworked medical community and lower medical costs for families with disabled children.”
NOVA successfully completed four preclinical studies that confirmed the therapeutic efficacy of its proprietary psilocybin-based drug and identified a therapeutic microdose for psilocybin that can be used in upcoming human studies. NOVA is the first biotech company to receive orphan drug designation for psilocybin FXS in the U.S. and the European Union, which will greatly help the company on its path to drug approval.
“We are thrilled with our ongoing permeability research and look forward to continuing the efforts to co-create a product with NOVA that safely and accurately delivers a controlled dose of drug to a child suffering from Fragile X,” added Chad Conner, Chief Executive Officer, Mycrodose Therapeutics. “We believe our sustained microdosing technology is an improved approach to delivering pharmaceutical compounds to patients who are not suited for or unwilling to accept the risks associated with a macrodose.”
Mycrodose’s state-of-the-art laboratory in Southern California offers a wide range of capabilities and combines an advanced analytical chemistry department with a highly experienced product development department. The analytical department has the instrumentation necessary to quantify and analyze virtually any active pharmaceutical ingredient (API) to the nearest millionth of a gram, and to determine all physicochemical parameters critical to the successful and optimal delivery of an API. In addition, stability-indicating tests are performed to evaluate and ensure the safety and consistency of the products, and special preparation equipment is used to isolate the individual isomers from racemic mixtures.
In October 2021, the two companies entered into a letter of intent (“LOI”) to form a joint venture (“NewCo”) that will accelerate the discovery and development of psilocybin-based therapeutics by leveraging Mycrodose Therapeutics’ patented advanced drug delivery systems with NOVA ‘s proprietary psilocybin-based drug portfolio to treat patients with neuroinflammatory disorders such as FXS, the most common inherited cause of ASD. NewCo aims to conduct FDA clinical trials with this novel technology in the first quarter of 2022.
