Cocrystal Pharma Showcases CDI-988, the First Oral Antiviral in Development for Norovirus Infection, in a Podium Presentation at the International Calicivirus Conference
Cocrystal Pharma (Nasdaq: COCP) presented Phase 1 data for CDI-988, their lead pan-viral protease inhibitor and potential first oral antiviral for norovirus infection, at the 9th International Calicivirus Conference. The presentation highlighted CDI-988's favorable safety profile in human intestinal tissue and broad-spectrum antiviral activity against multiple norovirus genogroups.
The company recently received FDA clearance for its Investigation New Drug (IND) application to proceed with a Phase 1b human challenge study, expected to begin before year-end. The drug, developed using Cocrystal's proprietary structure-based platform technology, targets a highly conserved region in the active site of noroviruses and showed no serious adverse events in Phase 1 trials.
Cocrystal Pharma (Nasdaq: COCP) ha presentato i dati di fase 1 di CDI-988, il loro principale inibitore proteas pan-virale e potenziale primo antiviral orale per l'infezione da norovirus, alla 9ª Conferenza Internazionale sui Calicivirus. La presentazione ha evidenziato il profilo di sicurezza favorevole di CDI-988 nei tessuti intestinali umani e l'attività antivirale a spettro ampio contro diversi genogruppi di norovirus.
L'azienda ha recentemente ottenuto l'approvazione FDA per la sua domanda IND (Investigational New Drug) per procedere con uno studio di Fase 1b di challenge nell'uomo, previsto prima della fine dell'anno. Il farmaco, sviluppato utilizzando la piattaforma tecnologica proprietaria basata sulla struttura di Cocrystal, mira a una regione altamente conservata nel sito attivo dei norovirus e non ha mostrato eventi avversi gravi negli studi di Fase 1.
Cocrystal Pharma (Nasdaq: COCP) presentó datos de Fase 1 de CDI-988, su principal inhibidor proteás pan-viral y potencial primer antiviral oral para la infección por norovirus, en la 9ª International Calicivirus Conference. La presentación destacó el perfil de seguridad favorable de CDI-988 en tejido intestinal humano y su actividad antiviral de amplio espectro contra múltiples genogrupos de norovirus.
La compañía recibió recientemente la aprobación de la FDA para su solicitud IND para avanzar con un estudio de Fase 1b de reto en humanos, previsto para comenzar antes de fin de año. El fármaco, desarrollado con la plataforma tecnológica propietaria de Cocrystal basada en la estructura, apunta a una región altamente conservada en el sitio activo de los norovirus y mostró no presentar eventos adversos graves en los ensayos de Fase 1.
Cocrystal Pharma (Nasdaq: COCP)는 세계 최초의 구강 항바이러스 후보인 다목적 단백질분해효소 억제제 CDI-988의 1상 데이터를 제9회 국제 칼리시바이러스 학회에서 발표했다. 발표는 인간 장 조직에서 CDI-988의 안전성 프로파일이 우수하고 여러 Norovirus 제노그룹에 대한 광범위한 항바이러스 활성을 강조했다.
회사는 최근 IND(임상시험용 신약) 승인을 받아 연말 이전에 시작될 것으로 예상되는 1b상 인간 도전 연구를 진행할 계획이다. 이 약물은 Cocrystal의 자체 구조 기반 플랫폼 기술로 개발되었으며 노로바이러스의 활성 부위에서 고도로 보존된 영역을 표적으로 하고 1상 시험에서 심각한 이상반응을 보이지 않았다.
Cocrystal Pharma (Nasdaq : COCP) a présenté des données de phase 1 pour CDI-988, leur principal inhibiteur protéase pan-viral et potentiel premier antiviral oral contre l’infection par le norovirus, lors de la 9e Conférence internationale sur les calicivirus. La présentation a mis en évidence le profil de sécurité favorable de CDI-988 dans les tissus intestinaux humains et son activité antivirale à large spectre contre plusieurs génotypes de norovirus.
La société a récemment obtenu l’autorisation de la FDA pour sa demande IND afin de réaliser une étude de phase 1b chez l’homme par challenge, qui devrait commencer avant la fin de l’année. Le médicament, développé grâce à la plateforme technologique propriétaire basée sur la structure de Cocrystal, cible une région fortement conservée dans le site actif des norovirus et n’a pas montré d’événements indésirables graves lors des essais de phase 1.
Cocrystal Pharma (Nasdaq: COCP) präsentierte Phasen-1-Daten zu CDI-988, ihrem führenden pan-viralen Protease-Inhibitor und potenziellen ersten oralen Antiviralum gegen Norovirus-Infektionen, auf der 9. International Calicivirus Conference. Die Präsentation hob das vorteilhafte Sicherheitsprofil von CDI-988 in menschlichem Darmgewebe und die Breitband-Aktivität gegen mehrere Norovirus-Genogruppen hervor.
Das Unternehmen erhielt kürzlich die FDA-Zulassung für seinen IND-Antrag, um eine Phase-1b-Challenge-Studie am Menschen durchzuführen, die voraussichtlich noch in diesem Jahr beginnen wird. Das Medikament wurde unter Verwendung von Cocrystal's eigener strukturbasierter Plattformtechnologie entwickelt, zielt auf eine hoch konservierte Region im aktiven Zentrum der Noroviren ab und zeigte in den Phase-1-Studien keine schweren unerwünschten Ereignisse.
Cocrystal Pharma (ناسداك: COCP) قدمت بيانات المرحلة 1 لـ CDI-988، أبرز مثبط إنزيم البروتينات الفيروسي واسع النطاق وربما أول مضاد فيروسٍ فموي للنوروفيروس، في المؤتمر الدولي التاسع Calicivirus. أبرز العرض ملف السلامة الواعد لـ CDI-988 في أنسجة الأمعاء البشرية ونشاطه المضاد للفيروسات عبر نطاق واسع ضد سلالات نوروفيروس متعددة.
مؤخراً، تلقت الشركة موافقة إدارة الغذاء والدواء الأمريكية (FDA) على طلب IND للمضي قدمًا في دراسة تحدي بشرية من المرحلة 1b، المتوقع أن تبدأ قبل نهاية السنة. الدواء، المطور باستخدام منصة التكنولوجيا القائمة على البنية الخاصة بشركة Cocrystal، يستهدف منطقة highly conserved في الموقع النشط للنوروفيروس ولم تُظهر الدراسات من المرحلة 1 أحداثًا جانبية خطيرة.
Cocrystal Pharma（纳斯达克: COCP） 在第九届国际钙病毒大会上公布了其领先的泛病毒蛋白酶抑制剂 CDI-988 的1期数据，该药有望成为治疗诺如病毒感染的首个口服抗病毒药物。报告强调 CDI-988 在人体肠道组织中的安全性良好，以及对多种诺如病毒基因组群的广谱抗病毒活性。
公司最近获FDA批准其 IND 申请，得以开展1b期人群挑战研究，预计将在年内开始。该药物利用 Cocrystal 的专有结构基础平台技术开发，针对诺如病毒活性位点中高度保守的区域，在1期试验中未显示出严重不良事件。
- FDA clearance received for Phase 1b human challenge study
- CDI-988 demonstrated favorable safety and tolerability in Phase 1 with no serious adverse events
- Drug shows broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17
- Potential to address $60 billion global market in healthcare costs and lost productivity
- Early-stage clinical development with no efficacy data yet
- Success in human challenge study still uncertain
Insights
Cocrystal's norovirus drug CDI-988 advances to Phase 1b after successful Phase 1, targeting a $60B global health burden.
Cocrystal's CDI-988 represents a potentially groundbreaking development as the first oral antiviral targeting norovirus infection. The company has successfully completed Phase 1 studies and secured FDA clearance for a Phase 1b human challenge study, which will evaluate the drug as both prophylaxis and treatment. This progression demonstrates positive momentum in their clinical pipeline.
The mechanistic data presented at the conference reveals CDI-988's strategic design using Cocrystal's proprietary structure-based platform. The drug targets a highly conserved region in viral proteases, potentially enabling broad-spectrum activity against multiple norovirus genogroups including the predominant GII.4 and GII.17 strains. This approach could offer an advantage over narrowly-targeted antivirals.
Particularly notable is CDI-988's favorable safety profile and high exposure in the small intestine – the primary site of norovirus infection. This GI-targeted approach may maximize efficacy while potentially minimizing systemic side effects. With norovirus responsible for an estimated
The upcoming Phase 1b human challenge study, expected to commence before year-end, will provide critical proof-of-concept data. This study design, where volunteers are deliberately exposed to the virus, can rapidly generate efficacy signals compared to traditional field studies where researchers must wait for natural infection.
BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 represents a potential first oral antiviral for the prevention and treatment of norovirus infection.
“It was an honor to share highlights of our CDI-988 Phase 1 data with global norovirus experts at the leading calicivirus scientific meeting,” said Dr. Lee. “The recent completion of Phase 1 study and U.S. Food and Drug Administration’s (FDA) Investigation New Drug (IND) clearance for the next study mark significant milestones for our clinical development of CDI-988.”
In “Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Mechanism of Action and Phase 1 Study Results,” Dr. Lee emphasized CDI-988’s favorable safety profile in human intestinal tissue, the primary site of norovirus infection, along with its high exposure in small intestine, suggesting a potential GI-targeted norovirus antiviral.
CDI-988 was rationally designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In vitro potency data and high-resolution crystal structures have shown broad-spectrum antiviral activity against multiple norovirus genogroups including GII.4 and GII.17, the strain responsible for the majority of circulating infections.
Dr. Lee also discussed previously reported Phase 1 results demonstrating CDI-988’s favorable safety and tolerability profile, with no serious adverse events. Earlier this week, Cocrystal announced FDA authorization to proceed with a Phase 1b human challenge study to evaluate CDI-988 as a potential norovirus prophylaxis and treatment. The study is expected to begin before year end.
The Calicivirus Conference is held every three years and unites scientists from across the globe who study calicivirus virology, evolution, pathogenesis, structural biology, diagnosis, epidemiology, treatment and prevention. The conference aims to foster open discussions, spark new collaborations and explore groundbreaking research. Delegates at this year’s conference engaged with the latest advances in the field through state-of-the-art lectures, oral presentations and poster sessions.
Protease Inhibitor CDI-988
CDI-988 was designed and developed with Cocrystal’s proprietary structure-based platform technology as a broad-spectrum inhibitor to a highly conserved region in the active site of 3CL viral proteases. It targets a highly conserved region in the active site of noroviruses, coronaviruses and other 3CL viral proteases.
Norovirus Infection
Norovirus, the leading cause of viral gastroenteritis worldwide, spreads rapidly in community settings such as hospitals, nursing homes, childcare facilities, schools and cruise ships. It causes nausea, vomiting, diarrhea, abdominal pain and dehydration, and is responsible for an estimated
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 and Nobel Prize-winning expertise 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 the potential efficacy of CDI-988 as a potential antiviral for the prevention and treatment of norovirus infection, and the Company’s plan to initiate a Phase 1b study in 2025. 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, 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, risks relating to our ability to obtain regulatory approval for and proceed with clinical trials and our liquidity needs. 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, 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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