Cocrystal Pharma’s Norovirus Oral Antiviral Candidate Demonstrates Potent Activity Against the Emerging GII.17 Variants
Cocrystal Pharma (NASDAQ: COCP) announces significant progress with its norovirus oral antiviral candidate CDI-988, which has demonstrated potent activity against emerging GII.17 variants that have become the dominant strain in 2024-2025 U.S. and European outbreaks. The drug candidate shows broad-spectrum antiviral activity against both GII.4 and GII.17 strains.
CDI-988, a pan-viral protease inhibitor, has completed Phase 1 trials with favorable safety and tolerability results. The company plans to initiate a human challenge study in 2025 for both treatment and prevention of norovirus infection. The drug targets the highly conserved region of the GII.17 protease, representing a potential first-in-class oral antiviral treatment.
Notably, norovirus causes approximately 685 million cases and 50,000 child deaths annually worldwide, with an estimated societal cost of $60 billion. Currently, there are no approved antiviral treatments or vaccines available.
Cocrystal Pharma (NASDAQ: COCP) annuncia importanti progressi con il suo candidato antivirale orale contro il norovirus, CDI-988, che ha dimostrato un’efficace attività contro le varianti emergenti GII.17, diventate il ceppo dominante negli episodi epidemici del 2024-2025 negli Stati Uniti e in Europa. Il farmaco mostra un’attività antivirale ad ampio spettro contro i ceppi GII.4 e GII.17.
CDI-988, un inibitore pan-virale della proteasi, ha completato la Fase 1 con risultati favorevoli in termini di sicurezza e tollerabilità. L’azienda prevede di avviare uno studio di sfida umana nel 2025, sia per il trattamento sia per la prevenzione dell’infezione da norovirus. Il farmaco agisce su una regione altamente conservata della proteasi GII.17, rappresentando un potenziale trattamento antivirale orale di prima classe.
È importante sottolineare che il norovirus causa circa 685 milioni di casi e 50.000 decessi infantili ogni anno nel mondo, con un costo sociale stimato di 60 miliardi di dollari. Attualmente non esistono trattamenti antivirali o vaccini approvati.
Cocrystal Pharma (NASDAQ: COCP) anuncia avances significativos con su candidato antiviral oral contra el norovirus, CDI-988, que ha demostrado una potente actividad contra las variantes emergentes GII.17, que se han convertido en la cepa dominante en los brotes de EE. UU. y Europa en 2024-2025. El fármaco muestra actividad antiviral de amplio espectro contra las cepas GII.4 y GII.17.
CDI-988, un inhibidor pan-viral de la proteasa, ha completado los ensayos de Fase 1 con resultados favorables en seguridad y tolerabilidad. La compañía planea iniciar un estudio de desafío humano en 2025 para el tratamiento y la prevención de la infección por norovirus. El fármaco se dirige a una región altamente conservada de la proteasa GII.17, representando un posible tratamiento antiviral oral de primera clase.
Es importante destacar que el norovirus causa aproximadamente 685 millones de casos y 50,000 muertes infantiles anuales en todo el mundo, con un costo social estimado de 60 mil millones de dólares. Actualmente no existen tratamientos antivirales ni vacunas aprobadas.
Cocrystal Pharma (NASDAQ: COCP)는 노로바이러스 경구용 항바이러스제 후보물질 CDI-988의 중요한 진전을 발표했습니다. 이 후보물질은 2024-2025년 미국과 유럽에서 우세한 GII.17 변종에 대해 강력한 효능을 보였습니다. 이 약물은 GII.4와 GII.17 두 가지 유형 모두에 대해 광범위한 항바이러스 활성을 나타냅니다.
CDI-988은 범바이러스 프로테아제 억제제로, 1상 임상을 안전성과 내약성 측면에서 우수한 결과를 얻으며 완료했습니다. 회사는 2025년에 노로바이러스 감염의 치료 및 예방을 위한 인간 도전 시험을 시작할 계획입니다. 이 약물은 GII.17 프로테아제의 고도로 보존된 부위를 표적으로 하여 최초의 경구용 항바이러스제 가능성을 지닙니다.
특히, 노로바이러스는 전 세계적으로 매년 약 6억 8,500만 건의 감염과 5만 명의 어린이 사망을 일으키며, 사회적 비용은 약 600억 달러에 달합니다. 현재 승인된 항바이러스 치료제나 백신은 없습니다.
Cocrystal Pharma (NASDAQ : COCP) annonce des progrès significatifs avec son candidat antiviral oral contre le norovirus, CDI-988, qui a démontré une activité puissante contre les variantes émergentes GII.17, devenues la souche dominante lors des épidémies américaines et européennes de 2024-2025. Le médicament présente une activité antivirale à large spectre contre les souches GII.4 et GII.17.
CDI-988, un inhibiteur pan-viral de la protéase, a achevé les essais de phase 1 avec des résultats favorables en termes de sécurité et de tolérance. La société prévoit de lancer une étude de défi humain en 2025 pour le traitement et la prévention de l’infection à norovirus. Le médicament cible une région hautement conservée de la protéase GII.17, représentant un traitement antiviral oral potentiellement innovant.
Il est à noter que le norovirus cause environ 685 millions de cas et 50 000 décès infantiles chaque année dans le monde, avec un coût sociétal estimé à 60 milliards de dollars. À ce jour, aucun traitement antiviral ni vaccin approuvé n’est disponible.
Cocrystal Pharma (NASDAQ: COCP) meldet bedeutende Fortschritte mit seinem oralen antiviralen Kandidaten CDI-988 gegen Norovirus, der eine starke Wirksamkeit gegen die aufkommenden GII.17-Varianten zeigt, die in den Ausbrüchen 2024-2025 in den USA und Europa dominant sind. Der Wirkstoff zeigt ein breites antivirales Spektrum gegen die Stämme GII.4 und GII.17.
CDI-988, ein pan-viraler Proteaseinhibitor, hat die Phase-1-Studien mit günstigen Ergebnissen hinsichtlich Sicherheit und Verträglichkeit abgeschlossen. Das Unternehmen plant, 2025 eine Human-Challenge-Studie zur Behandlung und Prävention von Norovirus-Infektionen zu starten. Das Medikament zielt auf eine hochkonservierte Region der GII.17-Protease ab und stellt damit eine potenzielle erste orale antivirale Behandlung ihrer Art dar.
Bemerkenswert ist, dass Norovirus weltweit jährlich etwa 685 Millionen Fälle und 50.000 Kindersterbefälle verursacht, mit geschätzten gesellschaftlichen Kosten von 60 Milliarden US-Dollar. Derzeit gibt es keine zugelassenen antiviralen Therapien oder Impfstoffe.
- Successful demonstration of broad-spectrum antiviral activity against dominant norovirus strains
- Favorable Phase 1 safety and tolerability results
- First-in-class potential with novel mechanism of action
- Addresses large market opportunity ($60B societal cost)
- No current competition (no approved antivirals or vaccines)
- Human challenge studies not yet initiated
- Development still in early stages
- Complex viral diversity (10 genogroups, 49 genotypes) poses development challenges
Insights
Cocrystal's norovirus drug shows promising cross-variant activity, advancing toward human challenge trials after successful Phase 1 completion in a large untapped market.
Cocrystal Pharma has achieved a significant milestone with its norovirus oral antiviral candidate CDI-988, demonstrating potent activity against both traditional GII.4 and emerging GII.17 norovirus variants. This breakthrough is particularly timely as GII.17 variants have now overtaken GII.4 as the most prevalent strain, causing increased outbreaks across the U.S. and Europe in 2024-2025.
The company has successfully completed a Phase 1 study showing favorable safety and tolerability of CDI-988, positioning them to advance to a human challenge study planned for 2025. This progression represents structured advancement through the clinical development pathway for what could potentially become a first-in-class oral antiviral for norovirus.
The market opportunity is substantial, with norovirus causing an estimated
CDI-988's dual potential for both prevention and treatment of norovirus infection could expand its commercial applications. Additionally, the compound's design as a pan-viral inhibitor may offer activity against both noroviruses and coronaviruses, potentially broadening its utility.
Cocrystal's proprietary structure-based platform technology provides the company with distinctive capabilities in antiviral development, enabling rapid structural determination and drug optimization. This technology has facilitated their achievement of determining the first crystal structure of GII.17 protease, demonstrating the platform's value beyond individual drug candidates.
Cocrystal's CDI-988 targets conserved viral protease regions, potentially solving the challenge of norovirus variant diversity that has hampered treatment development.
The emergence of GII.17 norovirus variants as dominant strains represents a significant epidemiological shift in the norovirus landscape. This development highlights one of the fundamental challenges in developing effective interventions against norovirus: its extensive genetic diversity spanning 10 genogroups and 49 genotypes.
Cocrystal's approach tackles this challenge directly by targeting a highly conserved region in the active site of 3CL viral proteases. Their compound CDI-988 binds to this conserved region with excellent potency across both GII.4 and GII.17 variants, potentially addressing the variant diversity problem that has historically complicated norovirus drug development.
The company's achievement in determining the first crystal structure of GII.17 protease represents a notable scientific advancement that enabled rational drug design against this target. This structural biology approach allows precise targeting of viral vulnerabilities that remain consistent across variants.
The planned human challenge study will be a critical test of CDI-988's efficacy in both preventing and treating norovirus infection. This study design, where volunteers are deliberately exposed to the virus, can provide more direct evidence of efficacy than traditional clinical trials for infectious diseases with episodic outbreaks.
Norovirus has been a particularly difficult target for therapeutic development due to challenges in cultivating the virus in laboratory settings and its rapid mutation rate. CDI-988's mechanism of targeting conserved protease regions represents a promising strategy to overcome these hurdles and potentially deliver the first effective intervention against this widespread pathogen.
- Norovirus GII.17 variants have overtaken GII.4 as the most prevalent strain and significantly increased norovirus outbreaks in the U.S. and European countries in 2024-2025
- Cocrystal Pharma’s pan-viral protease inhibitor CDI-988 shows superior broad-spectrum antiviral activity against major norovirus variants including GII.4 and GII.17 strains
- Company reported favorable safety and tolerability of CDI-988 in Phase 1 and plans to initiate a human challenge study in 2025 for the treatment and prevention of norovirus infection
BOTHELL, Wash., April 24, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that its investigative drug candidate CDI-988 was shown to bind to the highly conserved region of the GII.17 protease with excellent potency, similar to that shown across a range of GII.4 norovirus variants that had been the dominant worldwide strains until this year. The high resolution GII.17 protease crystal structures used in determining CDI-988’s activity were obtained using the Company’s proprietary structure-based platform technology. Cocrystal plans to initiate a human norovirus challenge study in 2025 in the U.S. to evaluate CDI-988 as a potential prevention and treatment of norovirus infection.
“Norovirus is the most common cause of acute gastroenteritis worldwide, yet there are no approved antiviral treatments or vaccines available to combat it,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Norovirus antiviral and vaccine development has been extremely challenging due to high diversity among variants that include 10 genogroups and 49 genotypes. We are gratified to have determined the first crystal structure of GII.17 protease and demonstrated broad-spectrum antiviral activity of CDI-988 against newly circulating major norovirus GII.17 variants. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral antiviral to be used for both prevention and treatment of norovirus infection.”
“Norovirus is a noteworthy research target considering that each year an estimated 685 million cases and approximately 50,000 child deaths are attributed to this virus worldwide, leading to a societal cost estimated at
Pan-Viral Inhibitor CDI-988
CDI-988 is a protease inhibitor specifically designed and developed as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a compelling candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. The Company has completed a single-center, randomized, double-blind Phase 1 study in healthy adults evaluating safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo.
Structure-Based Platform Technology
Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps to identify novel binding sites and allows for a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of best-in-class antiviral therapies that have fast onset of action and/or shortened treatment time, are safe, well tolerated and easy to administer, are effective against all viral subtypes that cause disease and have a high barrier to viral resistance.
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 noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. 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 Cocrystal’s plans to initiate a human challenge study in 2025 for its oral norovirus product candidate, the potential efficacy of such product candidate, and the potential market for such 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, our need for additional capital to fund our operations over the next 12 months, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for such studies by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the impact of the Trump Administration’s policies and actions on regulations affecting the FDA and other healthcare agencies and potential staffing issues resulting therefrom, as well as other government actions such as tariffs which may cause delays or force us to incur additional costs to proceed with our development programs. 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.
Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com
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