Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment
Cocrystal Pharma (Nasdaq: COCP) has received FDA clearance to proceed with a Phase 1b challenge study for CDI-988, their novel oral broad-spectrum protease inhibitor targeting norovirus infections. The study is expected to begin by year-end 2025.
CDI-988 represents a potential breakthrough as the first antiviral drug candidate for norovirus prevention and treatment, with no currently approved vaccines or therapeutics available. The drug has demonstrated broad-spectrum antiviral activity against major norovirus proteases including GII.4 and GII.17, and showed favorable safety in Phase 1 studies.
Cocrystal Pharma (Nasdaq: COCP) ha ricevuto l'autorizzazione dalla FDA per avviare uno studio challenge di Fase 1b su CDI-988, il loro nuovo inibitore proteasico orale a largo spettro mirato alle infezioni da norovirus. Lo studio dovrebbe partire entro la fine del 2025.
CDI-988 rappresenta un potenziale passo avanti come il primo candidato antivirale per la prevenzione e il trattamento del norovirus, in un contesto privo di vaccini o terapie approvate. Il farmaco ha mostrato attività antivirale a largo spettro contro i principali proteasi del norovirus, inclusi GII.4 e GII.17, e ha evidenziato un profilo di sicurezza favorevole negli studi di Fase 1.
Cocrystal Pharma (Nasdaq: COCP) ha recibido la aprobación de la FDA para proceder con un estudio de desafío de Fase 1b de CDI-988, su nuevo inhibidor proteasa oral de amplio espectro dirigido a las infecciones por norovirus. Se espera que el estudio comience antes de finales de 2025.
CDI-988 podría suponer un avance como el primer candidato antiviral para la prevención y el tratamiento del norovirus, dado que actualmente no existen vacunas ni terapias aprobadas. El medicamento ha mostrado actividad antiviral de amplio espectro contra las principales proteasas del norovirus, incluidas GII.4 y GII.17, y presentó un perfil de seguridad favorable en estudios de Fase 1.
Cocrystal Pharma (Nasdaq: COCP)가 노로바이러스 감염을 표적으로 하는 새로운 경구용 광범위 프로테아제 억제제 CDI-988의 1b상 챌린지(도전) 시험 진행에 대해 FDA 승인을 받았습니다. 이 시험은 2025년 말까지 시작될 것으로 예상됩니다.
CDI-988은 현재 승인된 백신이나 치료제가 없는 상황에서 노로바이러스 예방 및 치료를 위한 최초의 항바이러스 후보약이 될 가능성을 지니고 있습니다. 이 약물은 GII.4 및 GII.17을 포함한 주요 노로바이러스 프로테아제에 대해 광범위한 항바이러스 활성을 보였고, 1상 시험에서 안전성 프로파일도 양호하게 나타났습니다.
Cocrystal Pharma (Nasdaq: COCP) a obtenu l'autorisation de la FDA de lancer une étude challenge de Phase 1b pour CDI-988, son nouvel inhibiteur de protéase oral à large spectre ciblant les infections à norovirus. L'étude devrait débuter d'ici la fin 2025.
CDI-988 représente une avancée potentielle en tant que premier candidat antiviral pour la prévention et le traitement du norovirus, alors qu'aucun vaccin ou traitement n'est actuellement approuvé. Le médicament a montré une activité antivirale à large spectre contre les principales protéases du norovirus, notamment GII.4 et GII.17, et a présenté un profil de sécurité favorable lors des études de Phase 1.
Cocrystal Pharma (Nasdaq: COCP) hat von der FDA die Zulassung erhalten, eine Phase-1b-Challenge-Studie mit CDI-988 durchzuführen, ihrem neuen oralen Breitband-Proteaseinhibitor gegen Norovirus-Infektionen. Die Studie soll bis Ende 2025 beginnen.
CDI-988 könnte einen Durchbruch darstellen als der erste antivirale Wirkstoffkandidat zur Prävention und Behandlung von Norovirus-Infektionen, da derzeit keine zugelassenen Impfstoffe oder Therapien verfügbar sind. Das Medikament zeigte breitbandige antivirale Aktivität gegen wichtige Norovirus-Proteasen, einschließlich GII.4 und GII.17, und wies in Phase-1-Studien ein günstiges Sicherheitsprofil auf.
- First-mover advantage as no approved treatments exist for norovirus infections
- FDA clearance received for Phase 1b challenge study
- Broad-spectrum effectiveness demonstrated against major norovirus proteases
- Favorable safety profile shown in Phase 1 studies
- Early-stage clinical development with efficacy yet to be proven in infected patients
- Significant time and resources required for further clinical development
Insights
FDA clearance for Cocrystal's CDI-988 norovirus drug represents significant milestone as potential first-ever treatment in an untapped market.
Cocrystal's FDA clearance to proceed with a Phase 1b challenge study for CDI-988 represents a significant regulatory milestone in addressing a substantial unmet medical need. The fact that there are currently no approved vaccines or treatments for norovirus infections positions CDI-988 as a potential first-in-class therapy in this space.
The clinical importance here is substantial: norovirus is the leading cause of acute viral gastroenteritis globally, responsible for approximately 685 million cases annually, yet treatment options remain limited to symptom management. CDI-988's mechanism as a pan-viral 3CL protease inhibitor is particularly promising given its demonstrated activity against major norovirus variants including the prevalent GII.4 and GII.17 strains.
What's technically impressive is the drug's dual potential for both prevention and treatment, suggesting possible prophylactic use in high-risk settings like cruise ships, healthcare facilities, and schools where norovirus outbreaks commonly occur. The favorable safety profile from Phase 1 studies reduces near-term development risk.
The targeted year-end 2025 timeline for the Phase 1b challenge study represents an important inflection point. Challenge studies, where healthy volunteers are deliberately exposed to the pathogen, typically provide more definitive early efficacy signals than traditional trials. If successful, this could accelerate CDI-988's development pathway considerably compared to conventional clinical programs.
From a competitive standpoint, Cocrystal currently faces limited competition in the norovirus treatment landscape, potentially giving them first-mover advantage in an underserved market with significant commercial potential.
- There are currently no approved vaccines or treatments for norovirus infection
- Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
- Phase 1b study is expected to start by year-end 2025
BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal’s oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus – the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025.
CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections.
“The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development. CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection and has demonstrated impressive data to date with broad antiviral activity,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “We look forward to the planned initiation of our Phase 1b challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”
About Norovirus
Norovirus infections affect millions globally, spreading rapidly through direct contact and contaminated food and surfaces. The virus is particularly problematic in confined environments such as cruise ships, hospitals, and military facilities. In the U.S., norovirus causes an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. Vulnerable populations, including infants, elderly and those immuno-compromised, can face more severe and prolonged infections. Individuals can remain contagious for weeks after symptoms are resolved, complicating containment efforts.
Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies to create first- and best-in-class antiviral drugs.
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 our plans to initiate a human Phase 1b challenge study for our norovirus product candidate. 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 ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the study, and our ability to meet our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. 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.
Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com
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FAQ
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