Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program

Cocrystal Pharma, Inc. has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19. CDI-988 and CDI-873 target a highly conserved region in the active site of SARS-CoV-2 main (3CL) protease required for viral RNA replication. Cocrystal plans to initiate a first-in-human trial with one selected candidate as soon as possible this year.

Although CDI-988 and CDI-873 are chemically differentiated, both exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against current variants of concern including Omicron. In preclinical studies, both candidates demonstrated a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing. Additionally, CDI-988 and CDI-873 were specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology.

“We are excited to have discovered two lead COVID-19 oral antiviral candidates that both demonstrate highly encouraging preclinical efficacy and safety data,” said Sam Lee, Cocrystal’s President and interim co-CEO. “We plan to continue evaluating both CDI-988 and CDI-873 for clinical development, while we are also rapidly advancing our inhalation/pulmonary SARS-CoV-2 lead candidate CDI-45205 toward clinical development. The objective of our multipronged strategy is to offer highly potent and safe antiviral therapeutics for hospitalized patients, as well as for those not requiring hospitalization, including for prophylactic use to provide protection to uninfected individuals who may become exposed. We expect one oral candidate in addition to our inhalation/pulmonary candidate to advance into clinical trials this year.”

“Cocrystal is focused on rapidly advancing COVID-19 therapeutic candidates with multiple routes of administration. The newly emerging Omicron variant continues to rapidly spread worldwide with breakthrough infection even in people who are fully vaccinated, demonstrating a critical need for effective antiviral therapy for COVID-19. We are very pleased to have two lead oral candidates, giving us a potential edge in the anticipated large oral delivery therapeutic market. In addition to initiating two COVID-19 trials in 2022, we anticipate completion of our influenza CC-42344 Phase 1 study this year,” said James Martin, Cocrystal’s CFO and interim co-CEO.

Earlier this month Cocrystal received guidance from the U.S. Food and Drug Administration (FDA) for further development of CDI-45205 in response to the Company’s pre-Investigational New Drug (IND) briefing package. The Company believes the FDA’s response clarifies the pathway for a planned Phase 1 study and provides direction for a subsequent Phase 2 study.