“We are very pleased with the progress that has been made with our clinical strategy for Bucillamine in the potential treatment of COVID-19, specifically with our focus on a Phase 3 confirmatory study to be conducted in the U.S. and our expansion into Canada,” said Michael Frank, Revive’s Chief Executive Officer.
The Company will have its Pre-CTA meeting with Health Canada this week. A complete briefing package accompanied the meeting request to discuss Bucillamine’s Chemistry, Manufacturing and Controls, non-clinical and clinical safety information, clinical trial design, and Health Canada’s guidance regarding the possibility of including an additional exploratory arm in the proposed trial in a subset of patients from the pediatric population. Results from the Pre-CTA meeting with Health Canada will be made available and the Company expects to initiate a clinical study as soon as possible following receipt of regulatory clearance from Health Canada.
Additionally, Revive is finalizing its IND with the U.S. FDA for the proposed Phase 3 confirmatory clinical trial to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 due to the SARS-CoV-2 infection. The Company will file the IND later this month and expects final approval to proceed to the Phase 3 study shortly thereafter.
Phase 3 Study Design
The Phase 3 study will be an adaptive design titled, A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine or Placebo in Patients with Mild-Moderate COVID-19. Symptomatic patients will initially be randomized 1:1:1 to receive Bucillamine 300 mg/day, Bucillamine 600 mg/day, or placebo.
The Phase 3 study will enroll a minimum of 210 patients, then a single Bucillamine dose is selected and a go/no-go decision is made. Patients will then be randomized 2:1 to the selected Bucillamine dose and placebo. Interim analyses will occur every 100 subjects up to the maximum sample size of 800 people. An independent data safety monitoring board (“DSMB”) will actively monitor interim data for the ongoing safety of patients.
The primary objective of the Phase 3 study is to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is a 3-level ordinal scale of a patient’s worst outcome between randomization and day 28. The levels of the ordinal outcome are 1) death, 2) alive and hospitalized, and 3) alive and not hospitalized.
Secondary objectives will aim to evaluate the safety of Bucillamine therapy at low (300 mg/day) and high (600 mg/day) dose levels when administered up to 14 days; to compare disease course in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo; to evaluate time to clinical improvement in patients with COVID- 19 receiving low- and high-dose Bucillamine compared with placebo; and to assess impact of Bucillamine therapy on supplemental oxygen needs of patients with COVID-19. In addition, an exploratory objective will be to evaluate the effects of Bucillamine on viral clearance from nasal swabs in patients with COVID-19.
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