Revive Therapeutics (RVV.C) files for FDA Orphan Drug Designation for psilocybin in traumatic brain injury

On April 27, 2021 Revive Therapeutics (RVV.C) announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for Psilocybin to treat moderate to severe Traumatic Brain Injury (TBI).

RVV is a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders.

Earlier this year, RVV and 17 other companies in the United States and Canada joined the first psychedelic exchange-traded fund – the Horizons Psychedelic Stock Index ETF (PSYK.NE).

“Brain Injury occurs at a rate of 500 out of 100,000 individuals yearly in Canada,” reports the NBIA, “From a population of 33,000,000, that translates to 165,000 serious brain injuries per year (rate does not include concussions – or mild traumatic brain injury, military injuries, or unreported cases)”.

“Of those, tens of thousands of become partially or permanently disabled, and more than 11,000 Canadians die,” added the NBIA.

An Orphan Drug Designation (ODD) status is given to medicines developed for serious conditions that require significant investment.

Key Criteria:

Treatment, diagnosis or prevention of a life-threatening or chronically debilitating condition
Prevalence below 5 per 10,000 persons
Marketing of the product is unlikely generate sufficient returns to justify the investment needed for its development
No satisfactory method of diagnosis, prevention or treatment of the concerned condition currently exists.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor.

“There are no FDA approved treatments for cognitive impairments due to TBI,” confirms RVV, “Moderate to severe TBI is a subset of TBI and can lead to a physical, cognitive, emotional, and behavioral changes over the course of a person’s life.”

“These changes may affect a person’s ability to function in their everyday life,” continues RVV, “Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia”.

Unlike degenerative diseases that can stalk you for decades, TBI typically strikes like a malevolent thunderbolt.

A bicycle ride to the grocery store can turn a gregarious young scientist into an irritable confused patient, incapable of working, socialising or reading.

In 2011, a young woman named Siobhan Pimlot fell 20 feet onto her head.

“A nurse who saw my accident thought I was dead,” recalled Pimlot in a well-written blog, “I became susceptible to further brain injuries, and since then I have suffered a further five”.

“I have communication problems,” added Pimlot, “I am partially deaf which is getting worse, and my memory is getting worse. Once I even forgot how to tie my shoelaces. Because of my first brain injury, quite a few of my friends stopped being my friends.”

“Psilocybin offers a potential solution to manage moderate to severe cases of TBI,” stated RVV, “Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability”.

“The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs,” states Michael Frank, CEO of Revive.

“We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders,” added Frank.

Five weeks ago, RVV announced it filed a patent application with the United States Patent and Trademark Office (USPTO) on an oral thin-film (OTF) delivery system to be used for psilocybin https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistration.

“The research was conducted in partnership with the Reed Research Group at the University of Wisconsin-Madison,” reported Equity Guru’s Piers Eaton.

“Revive is currently in discussions with a leading OTF manufacturer for a scale-up as they eye FDA phase I and II clinical studies for treatment of mental illnesses, neurological and substance abuse disorders,” added Eaton.

Equity Guru readers who invested in cannabis in 2017 know how profitable it can be to ride a macro-investment wave driven by a changing regulatory environment.

“On Nov. 3, 2020 the state of Oregon voted to legalize psychedelic mushrooms for therapeutic use, a first for the nation,” writes a Quartz Magazine Health and Science Reporter, “And residents of Washington DC passed a ballot initiative that would decriminalize magic mushrooms and other psychedelics”.

“The initiatives show support for loosening drug laws on psychedelics,” continues Quartz, “and sow the seeds for two potentially lucrative psychedelic markets: a recreational one and a medical one”.

“Revive is one of the early entrants to the burgeoning shrooms/psychedelics/psilocybin industry, a business that is so early it’s not yet legal,” wrote Chris Parry on March 20, 2020, “You could roll your eyes at that, but there are plenty of indicators to suggest the shroom movement will land quicker than medical marijuana did”.

The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.

Late last year, RVV signed a supply agreement with Havn Life Sciences (HAVN.C) to source naturally-derived psychedelic compounds, such as psilocybin, for use in future investigational new drug enabling studies and clinical trials under FDA guidelines.

The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time.

ODD would qualify psilocybin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.

Full Disclosure: RVV is an Equity Guru marketing client.