Benzinga | Dec 1, 2021 04:09PM EST

Cocrystal Pharma Highlights Presentation Of Preclinical Data From COVID-19 Antiviral Programs, Outlines Near-Term Clinical Plans At World Antiviral Congress

Unveils designs for Phase 1 and 2 studies with intranasal/pulmonary and oral SARS-CoV-2 protease inhibitors; trial initiations expected in 2022

BOTHELL, Wash., Dec. 01, 2021 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (NASDAQ:COCP) ("Cocrystal" or the "Company"), a clinical-stage biotechnology company, today presented favorable preclinical data from its COVID-19 programs and outlined its clinical plans to advance two antiviral compounds at the World Antiviral Congress 2021 in San Diego. The presentation, "Discovery of Oral, Broad-Spectrum SARS-CoV-2 Mpro Inhibitors: Advancing to Clinical Development," was delivered by Cocrystal President and co-interim CEO Sam Lee, PhD and is available here.

Dr. Lee's presentation highlighted the advantages of Cocrystal's unique structure-based drug discovery platform technology in designing novel broad-spectrum antiviral leads, currently focused on COVID-19, influenza, and norovirus. Within the COVID-19 programs, he discussed in vitro and in vivo properties of Cocrystal's intranasal and oral main protease (Mpro) inhibitors and its clinical development plans.

"Our goal is to develop multiple broad-spectrum antivirals for the treatment of COVID-19 using oral, intranasal, and intravenous routes of administration. We also believe that the broad-spectrum coverage of a COVID-19 antiviral against Delta, now the predominant SARS-CoV-2 variant, and newly emerging variants such as Omicron is extremely important. Our SARS-CoV-2 protease inhibitors showed broad-spectrum antiviral activity against Alpha, Beta, Delta, and Gamma variants in vitro. In addition, our high resolution cocrystal structures using our proprietary platform technology further confirmed these results," said Dr. Lee.

"We are currently advancing our intranasal lead, CDI-45205, and oral Mpro protease inhibitors. CDI-45205 showed a favorable safety profile when tested in human nasal airway epithelia in vitro and excellent pharmacokinetic properties via intratracheal delivery in preclinical studies. An intranasal/pulmonary delivery of a COVID-19 antiviral agent could be a potential therapeutic and prophylactic treatment of COVID-19 by blocking viral replication and transmission. We are delighted to share in vitro and oral pharmacokinetic results, development timelines, and Phase 1 and Phase 2 study designs at this premier international antiviral conference," Dr. Lee concluded.

Cocrystal also unveiled clinical trial designs for CDI-45205, an intranasal lead, and its oral SARS-CoV-2 inhibitors. The Phase 1 study is planned as a randomized, placebo-controlled, double-blind, single-ascending-dose/multiple-ascending-dose trial in healthy volunteers evaluating safety, tolerability, pharmacokinetics and the effect of food. The Phase 2 study is planned as a randomized, double-blind, placebo-controlled trial in non-hospitalized patients with mild or moderate COVID-19, with change is viral load as the primary outcome measure. Cocrystal is currently awaiting the FDA's response to the CDI-45205 pre-IND briefing package submission.