CDI-988 is an oral, broad-spectrum 3CL protease inhibitor used for the treatment of Covid-19. Credit: Felipe Esquivel Reed / commons.wikimedia.org.

Cocrystal Pharma has received approval from the Australian Human Research Ethics Committee (HREC) to initiate a Phase I trial of CDI-988 for the treatment of Covid-19.

CDI-988 is an oral, broad-spectrum 3CL protease inhibitor designed using Cocrystal’s proprietary drug discovery platform technology.

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The double-blind, randomised, dose-escalating, placebo-controlled study aims to to evaluate CDI-988’s tolerability, safety, and pharmacokinetics in healthy volunteers.

Cocrystal president and co-CEO Sam Lee said: “We are excited to have accomplished this milestone and look forward to initiating our CDI-988 clinical programme as an oral treatment for patients with Covid-19, as well as demonstrating our drug discovery platform technology capabilities.”

“CDI-988 was designed to bind to a highly conserved region of coronavirus and other viral proteases.

“Recent findings from our preclinical studies also show pan-viral activity against different RNA viruses, enabling the potential for additional clinical benefits. Further exploration of this pan-viral activity is ongoing.”

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CDI-988 demonstrated in vitro potency against SARS-CoV-2 and other coronaviruses. It also had a favourable safety profile and showed pharmacokinetic properties that would support daily oral dosing.

In August last year, Cocrystal Pharma selected hVIVO as a contract research organisation to conduct a Phase IIa human challenge trial of its oral antiviral candidate, CC-42344, for Influenza A.

The double-blind, single-centre, placebo-controlled trial analysed the safety, viral, and clinical measures of oral CC-42344 in participants with influenza A.