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FSD Pharma submitting Investigative New Drug Application to FDA to use FSD-201 for COVID-19 studies

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FSD Pharma Inc., a specialty, biotech pharmaceutical R&D company, focused on developing, over time, a robust pipeline of FDA approved synthetic compounds targeting the endocannabinoid system of the human body, has received permission from the FDA to submit an Investigational New Drug Application (IND) for the use of FSD-201 to treat COVID-19.

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Company: FSD Pharma Inc.
Website: http://www.FSDpharma.com
Stock Symbol: NASDAQ: HUGE
Date Published: Jun 4, 2020
Transcript: Available

Video Transcript:

I’m Fiona Forbes for Investmentpitch Media

FSD Pharma Inc., a specialty, biotech pharmaceutical R&D company, focused on developing, over time, a robust pipeline of FDA approved synthetic compounds targeting the endocannabinoid system of the human body, has received permission from the FDA to submit an Investigational New Drug Application (IND) for the use of FSD-201 to treat COVID-19.

Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death.

FSD Pharma is focused on developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

In July 2019, the company acquired Arizona-based Prismic Pharmaceuticals for $17.5 million as a platform company and installed a world class expert in the field, Dr. Ed Brennan, as the President of the Division.

It is through this acquisition that FSD Pharma is developing opioid-sparing prescription drugs utilizing the micronized formulations of palmitolylethanolamide or PEA, focusing on its anti-inflammatory properties.

FSD Pharma acquired worldwide rights, excluding Italy and Spain, to ultramicronized PEA from Epitech Group, an Italian pharmaceutical company that invented and holds the patents until 2034.

Epitech markets ultramicronized PEA as a prescription-based "Food for Special Medical Purposes" in Italy under the brand name Normast® 600mg oral tablets, for several chronic pain and inflammatory conditions, including sciatic pain and diabetic neuropathy.

Dr. Raza Bokhari, Executive Co-Chairman and CEO, stated: "FDA's permission to design a proof-of-concept study in COVID-19 patients evaluating clinical doses of FSD-201 is a paradigm shift for FSD Pharma and is the result of outstanding work conducted by Dr. Edward Brennan, President FSD BioSciences, and his team. We contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug's mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines. Numerous studies over the past 40 years also validate the efficacy and safety of ultramicronized PEA in the treatment and prophylactic effects in respiratory infections. These studies also pointed out that the ease of application of PEA offers the possibility to have a quick therapeutic answer ready in case of a flu epidemic."

Based on the FDA feedback received to date, the company expects the trial will be a randomized, controlled, double-blind, U.S. multicenter study to assess the efficacy and safety of FSD-201, dosed 600mg or 1200mg twice-daily plus standard of care versus standard of care alone in symptomatic patients.

At the end of the expected 14 day treatment period, all patients experiencing clinical benefit are expected to continue to receive their assigned treatment until study completion.

More than 600 scientific papers attest to the physiological properties of PEA, specifically its anti-inflammatory benefits.

Many clinical trials assessing the safety and efficacy of ultramicronized PEA on chronic pain have been published in the last decade.

A number of studies have demonstrated that ultramicronized PEA at doses up to 2700mg per day, administered to patients with various chronic pain syndromes, induced a significant decrease in pain intensity, compared with control groups.

More than 1,500 patients have received either ultramicronized or micronized PEA in clinical studies and no serious adverse events were reported in the vast majority of these studies.

FSD's wholly-owned subsidiary, FV Pharma, is a licensed producer under Canada’s Cannabis Act and Regulations, having received its cultivation license in October 2017 and its full Sale for Medical Purposes license in June 2019.

The company is licensed to cultivate cannabis in approximately 25,000 square feet of its facility in Cobourg, Ontario.

The shares are trading at $12.50 on the Canadian Securities Exchange.

For more information, or to view today’s news release, please visit the company’s website, www.FSDpharma.com, or contact Sandy Huard, Head of Communications, at 647-864-7969 or by email at sandy@FSDpharma.com.

For investor relations in Canada email IR@FSDpharma.com.

In the United States, contact Sanjay M. Hurry of LHA Investor Relations, who can be reached at 212-838-3777 or by email at SHurry@lhai.com.

I’m Fiona Forbes for Investmentpitch Media