Revive Files Pre-IND Meeting With FDA For COVID-19 Treatment

Revive Therapeutics (CSE: RVV) this morning announced that it has filed its pre-investigational new drug (Pre-IND) meeting request with the US Food and Drug Administration for the use of Bucillamine as a treatment against coronavirus and other infectious diseases.

Revive is currently relying on its previous investigative work with Bucillamine to assist in expediting communications with the FDA, with the goal of being approved for a phase 2 clinical study. The company has previously received phase 2 study approval for Bucillamine for the use of the drug as a treatment for gout and cystinuria.

The company is currently working with its contract research organization, Pharm-Olam, to finalize the protocol to be used in the proposed phase 2 clinical trial. The protocal, as currently developed, proposed a multi-center, randomized, double-blind, placebo-controlled, clinical study. The study will focus on patients with coronavirus currently exhibiting mild to moderate symptoms, with the objective of evaluating the course of the disease in patients receiving Bucillamine as compared to those receiving the placebo.

The study is to also analyze the safety of Bucillamine when administered for up to 14 days, and the time it takes to note clinical improvement in those receiving Bucillamine treatment versus those receiving the placebo.

We are excited to expedite the clinical investigation of Bucillamine in a proposed phase 2 clinical study in the U.S., and we believe our history with the FDA for Bucillamine will provide a compelling case. We will also seek to expand the clinical investigation of Bucillamine in Asian regions, with a particular interest in Japan and South Korea where Bucillamine has been prescribed for treating arthritis for over 30 years. We are in discussion with various contract research organizations (‘CRO’) in these regions.

Michael Frank, Revive’s Chief Executive Officer

Revive Therapeutics last traded at $0.12 on the CSE.


FULL DISCLOSURE: Revive Therapeutics is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Revive Therapeutics on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

Video Articles

2026 Could Be Gold’s Biggest Year Yet!? | Ryan King – Equinox Gold

Gold Is Screaming Higher While Currencies Burn | Simon Ridgway – Rackla Metals

We Have the Highest-Grade Antimony Deposit in North America!? | Jim Atkinson -Antimony Resources

Recommended

Canadian Copper Secures $8 Million Lead Order From Ocean Partners As Part Of Larger Funding Round

Northern Superior Expands Philibert With 350 Metre Step Out Testing 1.10 g/t Gold Over 25.5 Metres

Related News

Revive Therapeutics Files For Patent On Oral Thin Film With Psilocybin

Revive Therapeutics (CSE: RVV) this morning announced that it has successfully completed research on an...

Thursday, April 22, 2021, 08:18:53 AM

Revive Announces Timeline For Phase 3 Studies, Sees Beneficial Psilocybin Developments

Revive Therapeutics (CSE: RVV) this morning announced that on the heels of receiving FDA approval...

Wednesday, August 5, 2020, 09:50:58 AM

Revive Therapeutics Conducts $10.0 Million Bought Deal Financing

Revive Therapeutics (CSE: RVV) this evening announced that it will be conducting a bought deal...

Wednesday, January 20, 2021, 08:37:25 PM

Revive Therapeutics Closes $23.0 Million Bought Deal Financing

Revive Therapeutics (CSE: RVV) this morning announced the closing of its bought deal financing. Originally...

Friday, February 12, 2021, 11:38:53 AM

Revive Therapeutics Applies For Orphan Drug Designation For Psilocybin

Revive Therapeutics (CSE: RVV) has filed for orphan drug designation with the US Food and...

Tuesday, April 27, 2021, 09:34:32 AM