Revive Files Clinical Trial Application With Health Canada, Releases Phase 3 FDA Study Design For Potential Treatment Of COVID-19
Revive Therapeutics (CSE: RVV) continues to advance its clinical trial efforts. The company announced this morning that it has filed a clinical trial application (Pre-CTA) with Health Canada, as well as updated the market with the news that the company will be filing investigational new drug packaging to the US FDA later this month for the proposed Phase 3 clinical trials for use of Bucillamine as a treatment against COVID-19.
With respect to the development with Health Canada, Revive will be having its pre-CTA meeting with the agency later this week. The meeting will see Health Canada review a complete briefing package to discuss the use of Bucillamine in the treatment against mild-moderate COVID-19 infection.
Discussions will include clinical trial design, manufacturing and controls, chemistry, as well as Health Canada’s guidance on the posibility of including an additional exploratory arm in the proposed trial in a subset of patients from the pediatric population. Results from the meeting will be announced, with Revive expecting to initiate a clinical trial in Canada as soon as possible after receiving regulatory clearance from Health Canada.
With respect to its efforts in the USA, Revive is currently finalizing its investigational new drug (IND) package for the FDA. The IND for the proposed phase 3 confirmatory clinical trial to evaluate Bucillamine in the treatment of COVID-19 is expected to be filed later this month, with final approval to proceed to the Phase 3 study expected in short order.
Further, Revive also released study design on the proposed Phase 3 clinical trial, which is to enroll a minimum of 210 patients for trials. The design, to be entitled “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine or Placebo in Patients with Mild-Moderate COVID-19,” will be randomized with patients receiving either 300 mg/day of Bucillamine, 600 m/g a day, or a placebo.
The primary objective of the Phase 3 trial is to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 that receive Bucillamine to those that receive the placebo. Secondary objectives of the study will look to evaluate the safety of Bucillamine in the dosage formats when administered for up to 14 days, to compare the course of the disease of those receiving the treatment, to evaluate the time to clinical improvement based on dosage, and to assess the impact that Bucillamine has on the needs of supplemental oxygen.
An additional exploratory objective will be to evaluate the effects of Bucillamine on viral clearance from nasal swabs in patients with COVID-19.
Revive Therapeutics last traded at $0.30 on the CSE.
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