Nova Mentis, Mycrodose Team Up to Test Skin Patch Delivery of Psilocybin

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by Patricia Inácio, PhD |

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Nova Mentis and Mycrodose Therapeutics have teamed up to test whether psychedelic treatments, such as Nova’s psilocybin — a potential behavioral therapy for fragile X syndrome — can be delivered via the skin using Mycrodose’s transdermal technology.

The first studies assessing the diffusion of psychedelic compounds through the skin, called permeation studies, using Mycrodose’s technology, are underway.

According to Mycrodose, its skin patch technology allows for a sustained and controlled delivery of small (micro) doses of a psychedelic to be absorbed from the skin into the blood, bypassing the limitations associated with oral medicines, such as liver toxicity, psychosis, and the need for large (macro) dosing.

The companies believe that patients with fragile X and other neuroinflammatory conditions may not require a high dose of a psychedelic compound to benefit therapeutically.

“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,” Will Rascan, Nova’s president and CEO, said in a press release.

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Nova has completed, with success, four preclinical studies confirming the therapeutic efficacy of the company’s proprietary psilocybin-based therapy, and established a microdose therapeutic level that can be used in upcoming human studies.

“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,” said Chad Conner, CEO of Mycrodose.

“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,” Conner added.

The merger of Nova’s psychedelic compounds with Mycrodose’s transdermal technology for therapy delivery follows a letter of intent, signed in October 2021, to speed the research and development of psilocybin-based therapeutics for the treatment of neuroinflammatory conditions, including fragile X.

“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,” Rascan said.

The companies expect to start human clinical trials to test the transdermal delivery of the psychedelic by March.

Psilocybin was granted orphan drug designation in the U.S. and the European Union, which offers financial incentives for potential rare disease treatments.