Pharma Focus Europe

Revive Therapeutics Provides Update of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Wednesday, April 19, 2023

Revive Therapeutics Ltd., a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. Following the Type C meeting with the FDA, the Company has reviewed the current environment of new hospital admissions of patients with confirmed COVID-19 internationally and in the U.S., where it is steadily declining (Source: CDC), evaluated potential patient recruitment strategies, and discussed with potential pharmaceutical partners to pursue Bucillamine as a potential treatment for COVID-19.

After further regulatory discussions with various groups, the Company has now decided that it will have the Data Safety Monitoring Board (“DSMB”) review the Study’s Post-Dose selection data of approximately 500 subjects for efficacy. This will take place under the current Study’s protocol primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization. The DSMB may then recommend continuing the Study if there is a trend toward achieving statistical significance, halting the Study early due to statistical significance likely not going to be met, or halting the Study early due to positive efficacy showing statistical significance. In the latter case, the Company would request a meeting with the FDA to determine the appropriate next steps toward obtaining potential regulatory approval. Should the DSMB recommend continuing the Study, the Company will then evaluate the current environment of COVID-19 and the likelihood of efficiently obtaining hospitalizations for the remainder of the Study and potentially bringing a pharmaceutical partner to support the continuation of the Study. Should the DSMB recommend not to pursue the Study due to statistical significance likely not going to be met, the Company will accept the DSMB decision and seek an evaluation of COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation), which will support further discussions with the FDA and potential pharmaceutical partners to determine a suitable regulatory approval pathway for Bucillamine in the U.S. and internationally.

The Company is committed to advancing the clinical and commercial development of Bucillamine and plans to pursue the following activities:

  • Continue discussions with the FDA on a pathway for future potential regulatory approval under the Study’s objectives or clinical symptoms data;
  • Work with interested pharmaceutical partners to pursue potential international regulatory approvals and new clinical studies for Long COVID or COVID symptom-related conditions and various infectious, inflammatory and respiratory disorders; and
  • Develop reformulation strategies of Bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (i.e. ischemia-reperfusion injury, cystinuria), fast track, and breakthrough therapy designations.

At this time, the Company will only provide regular updates via press releases as information becomes available.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

 

Source: globenewswire.com

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