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FSD Pharma Jumps 200% After FDA Nod For Initiating Proof-Of-Concept Study Of COVID-19 Treatment

FSD Pharma Jumps 200% After FDA Nod For Initiating Proof-Of-Concept Study Of COVID-19 Treatment

Shares of FSD Pharma Inc (NASDAQ: HUGE) are advancing strongly Wednesday following an announcement regarding a potential COVID-19 drug.

What Happened?

FSD said the FDA has approved its IND application for studying FSD-201 for the treatment of SARS-CoV-2, the virus that causes COVID-19. FSD-201, according to the company, is ultramicronized palmitoylethanolamide, or PEA.

The company clarified that it's focused on developing the investigational asset for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

"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," said Raza Bokhari, co-chairman and CEO of the company.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

What's Next?

Based on the feedback from the FDA, FSD plans to conduct the proof-of-concept, or Phase 2a study, to assess the safety and efficacy of FSD-201, dosed 600mg or 1,200mg, twice-daily, plus standard-of-care, compared to standard-of-care alone in symptomatic COVID patients.

The company said the primary endpoint would be a significant improvement in clinical status – shorter time to symptom relief.

FSD said it expects the treatment period to be 14 days.

In pre-market trading, FSD shares were jumping 222.58% to $10.


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