Cocrystal Pharma Advances Oral Pan-Viral Protease Inhibitor CDI-988 into Phase 1 Multiple-Ascending Dose Cohorts
Cocrystal Pharma (Nasdaq: COCP) has initiated dosing in the multiple-ascending dose (MAD) portion of its Phase 1 study for CDI-988, an oral pan-viral protease inhibitor. This follows favorable results from the single-ascending dose (SAD) phase, which reported no serious adverse events. CDI-988, developed using Cocrystal’s proprietary drug discovery platform, targets viral gastroenteritis and COVID-19 caused by noroviruses and coronaviruses. The randomized, double-blind study in Australia evaluates the safety, tolerability, and pharmacokinetics of CDI-988 compared to a placebo in healthy adults. Topline results are expected in late 2024 or early 2025.
Cocrystal Pharma (Nasdaq: COCP) ha avviato la somministrazione nella fase di dosi multiple crescenti (MAD) del suo studio di Fase 1 per CDI-988, un inibitore della proteasi panVirale orale. Questo segue risultati favorevoli dalla fase di dosi singole crescenti (SAD), che non ha riportato eventi avversi gravi. CDI-988, sviluppato utilizzando la piattaforma proprietaria di scoperta di farmaci di Cocrystal, mira a trattare la gastroenterite virale e il COVID-19 causati da norovirus e coronavirus. Lo studio randomizzato, in doppio cieco, in Australia valuta la sicurezza, la tollerabilità e la farmacocinetica di CDI-988 rispetto a un placebo in adulti sani. I risultati principali sono attesi per la fine del 2024 o l'inizio del 2025.
Cocrystal Pharma (Nasdaq: COCP) ha iniciado la dosificación en la parte de dosis múltiples crecientes (MAD) de su estudio de Fase 1 para CDI-988, un inhibidor de la proteasa panviral oral. Esto sigue a resultados favorables de la fase de dosis únicas crecientes (SAD), que no reportó eventos adversos graves. CDI-988, desarrollado utilizando la plataforma de descubrimiento de fármacos de Cocrystal, tiene como objetivo tratar la gastroenteritis viral y el COVID-19 causados por norovirus y coronavirus. El estudio aleatorizado, doble ciego, en Australia evalúa la seguridad, la tolerancia y la farmacocinética de CDI-988 en comparación con un placebo en adultos sanos. Se esperan resultados generales a finales de 2024 o principios de 2025.
Cocrystal Pharma (Nasdaq: COCP)는 CDI-988의 1상 연구에서 다중 상승 용량(MAD) 부분의 투여를 시작했습니다. 이는 단일 상승 용량(SAD) 단계에서 심각한 부작용이 보고되지 않은 긍정적인 결과에 따른 것입니다. CDI-988은 Cocrystal의 독점 약물 발견 플랫폼을 사용하여 개발되었으며, 노로바이러스와 코로나바이러스에 의해 발생하는 바이러스성 위장염 및 COVID-19를 목표로 하고 있습니다. 호주에서 실시되는 이 무작위 이중 맹검 연구는 건강한 성인에서 CDI-988의 안전성, 내약성 및 약물 동태학을 위약과 비교하여 평가합니다. 주요 결과는 2024년 말 또는 2025년 초에 예상됩니다.
Cocrystal Pharma (Nasdaq: COCP) a lancé l'administration dans la partie des doses multiples croissantes (MAD) de son étude de Phase 1 pour CDI-988, un inhibiteur de protéase pan-viral oral. Cela fait suite à des résultats favorables de la phase de dose unique croissante (SAD), qui n'a signalé aucun événement indésirable grave. CDI-988, développé à l'aide de la plateforme de découverte de médicaments propriétaire de Cocrystal, vise à traiter la gastro-entérite virale et le COVID-19 causés par des norovirus et des coronavirus. L'étude randomisée, en double aveugle, réalisée en Australie évalue la sécurité, la tolérabilité et la pharmacocinétique de CDI-988 par rapport à un placebo chez des adultes en bonne santé. Les résultats globaux sont attendus fin 2024 ou début 2025.
Cocrystal Pharma (Nasdaq: COCP) hat die Dosierung im Abschnitt der mehrfach steigenden Dosen (MAD) seiner Phase-1-Studie für CDI-988, einen oralen pan-viralen Proteaseinhibitor, eingeleitet. Dies folgt auf positive Ergebnisse aus der Phase der einzelnen steigenden Dosen (SAD), die keine schwerwiegenden unerwünschten Ereignisse berichtete. CDI-988, das mit der proprietären Arzneimittelforschungsplattform von Cocrystal entwickelt wurde, zielt auf virale Gastroenteritis und COVID-19 ab, die durch Noroviren und Coronaviren verursacht werden. Die randomisierte, doppelblinde Studie in Australien bewertet die Sicherheit, Verträglichkeit und Pharmakokinetik von CDI-988 im Vergleich zu einem Placebo bei gesunden Erwachsenen. Die wichtigsten Ergebnisse werden Ende 2024 oder Anfang 2025 erwartet.
- Initiation of multiple-ascending dose (MAD) portion of Phase 1 study for CDI-988.
- Favorable safety and tolerability results from single-ascending dose (SAD) phase.
- CDI-988 targets both noroviruses and coronaviruses, addressing viral gastroenteritis and COVID-19.
- Topline results expected in late 2024 or early 2025.
- None.
Insights
The advancement of CDI-988 into Phase 1 multiple-ascending dose (MAD) cohorts is a significant milestone for Cocrystal Pharma. This oral pan-viral protease inhibitor shows promise as a potential first-in-class treatment for viral gastroenteritis and COVID-19 caused by noroviruses and coronaviruses. The favorable safety and tolerability results from the single-ascending dose (SAD) portion are encouraging, with no serious adverse events reported.
Key points to consider:
- CDI-988 targets viral proteases of both noroviruses and coronaviruses, potentially offering a broad-spectrum antiviral solution.
- The ongoing Phase 1 study is evaluating safety, tolerability and pharmacokinetics in healthy adults.
- Topline results are expected in late 2024 or early 2025, which could be a significant catalyst for the company.
- The use of Cocrystal's proprietary structure-based drug discovery platform technology in developing CDI-988 showcases the company's innovative approach.
While these early-stage results are promising, investors should remain cautious as the drug still has a long way to go before potential commercialization. The upcoming MAD results will be important in determining the drug's future development path.
BOTHELL, Wash., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces dosing of the first subjects in the multiple-ascending dose (MAD) portion of the Phase 1 study with CDI-988, its potent, broad-spectrum, oral pan-viral protease inhibitor. Topline study results are expected in late 2024 or early 2025. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology and is being developed as the first-in-class pan-viral antiviral for the treatment of viral gastroenteritis and COVID-19 caused by noroviruses and coronaviruses, respectively.
“We are delighted to advance the clinical evaluation of CDI-988, a novel direct-acting antiviral (DAA) targeting the viral proteases of noroviruses and coronaviruses,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “Multiple-ascending dose results will further evaluate safety and tolerability of this potentially groundbreaking antiviral therapeutic.”
This randomized, double-blind Phase 1 study, which is being conducted at a single center in Australia, is evaluating the safety, tolerability and pharmacokinetics of orally administered CDI-988 compared with placebo in healthy adults. In July 2024 Cocrystal reported favorable safety and tolerability results from study participants in the single-ascending dose (SAD) portion of the trial. All SAD participants completed the study with no reported serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.
About Noroviruses
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the Centers for Disease Control and Prevention (CDC). The estimated annual burden of noroviruses to the U.S. at
Coronaviruses Including SARS-CoV-2 and its Variants
Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 (which causes COVID-19) and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.
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 influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, 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 the potential efficacy of CDI-988 against coronaviruses and noroviruses, the expected timing of topline results of the MAD portion of the CDI-988 study, 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, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers for the MAD cohorts of the CDI-988 Phase 1 study 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, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. 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, 2023. 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:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com
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