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.
About The World Antiviral Congress
The World Antiviral Congress 2021 provides a venue for discussing antiviral vaccines, immunotherapies and antiviral therapies. The conference is focused on identifying the urgent priorities for research, and mobilizing, coordinating and aligning funding needed to tackle these crises. The conference features key opinion leaders from around the world in the area of antivirals discussing topics such as tackling future viral pandemics, emerging approaches to antivirals including the treatment of COVID-19 and respiratory diseases. The World Antiviral Congress 2021 agenda is available here.
CDI-45205 is among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV infected mice.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the goal of developing multiple broad-spectrum antivirals for the treatment of COVID-19 and expectations for initiating Phase 1 and Phase 2 clinical trials. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, including raw material and test animal shortages and other supply chain disruptions, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from the lockdowns in Australia, potential delays related to the manufacturing of drugs for studies, the cooperation of the FDA in accelerating development in our COVID-19 program, the results of clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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