Cocrystal Pharma to Extend Phase 2a Influenza Challenge Study with Oral PB2 inhibitor CC-42344
Cocrystal Pharma (NASDAQ: COCP) announces plans to extend enrollment in their Phase 2a human challenge study for CC-42344, their oral influenza PB2 inhibitor, due to unexpectedly low influenza infection rates among study participants. While the drug demonstrated a favorable safety and tolerability profile with no serious adverse events or drug-related discontinuations, the low infectivity of the H3N2 viral strain used in the study made virology results uninterpretable.
The company is working with their clinical research organization to prepare a protocol amendment for UK MHRA approval to extend enrollment and ensure necessary infection rates. CC-42344 is being developed as an oral treatment for pandemic avian and seasonal influenza A infections, featuring a unique mechanism of action with a high barrier to developing resistance.
Cocrystal Pharma (NASDAQ: COCP) annuncia l'intenzione di estendere l'arruolamento nel loro studio clinico di fase 2a per il CC-42344, un inibitore orale della PB2 per l'influenza, a causa di tassi di infezione influenzale inaspettatamente bassi tra i partecipanti dello studio. Sebbene il farmaco abbia dimostrato un profilo di sicurezza e tollerabilità favorevole senza eventi avversi gravi o interruzioni legate al farmaco, la bassa infettività del ceppo virale H3N2 utilizzato nello studio ha reso i risultati virologici incomprensibili.
L'azienda sta lavorando con la propria organizzazione di ricerca clinica per preparare un emendamento al protocollo per l'approvazione dell'MHRA del Regno Unito per estendere l'arruolamento e garantire i tassi di infezione necessari. Il CC-42344 è in fase di sviluppo come trattamento orale per le infezioni da influenza A pandemica avicola e stagionale, caratterizzato da un meccanismo d'azione unico con un'elevata barriera alla resistenza.
Cocrystal Pharma (NASDAQ: COCP) anuncia planes para extender el reclutamiento en su estudio clínico de fase 2a para el CC-42344, un inhibidor oral de PB2 para la influenza, debido a tasas de infección por influenza inesperadamente bajas entre los participantes del estudio. Mientras que el medicamento demostró un perfil de seguridad y tolerabilidad favorable sin eventos adversos graves o discontinuaciones relacionadas con el medicamento, la baja infectividad de la cepa viral H3N2 utilizada en el estudio hizo que los resultados virológicos fueran incomprensibles.
La empresa está trabajando con su organización de investigación clínica para preparar una enmienda al protocolo para la aprobación de la MHRA del Reino Unido para extender el reclutamiento y asegurar las tasas de infección necesarias. El CC-42344 se está desarrollando como un tratamiento oral para infecciones por influenza A aviar pandémica y estacional, presentando un mecanismo de acción único con una alta barrera para desarrollar resistencia.
코크리스탈 파마 (NASDAQ: COCP)은 인플루엔자 PB2 억제제 CC-42344에 대한 2단계 인체 도전 연구의 등록을 연장할 계획을 발표했습니다. 이는 연구 참가자들 사이에서 인플루엔자 감염률이 예상보다 낮았기 때문입니다. 이 약물은 심각한 이상 반응이나 약물 중단 없이 유리한 안전성 및 내약성 프로필을 나타냈으나, 연구에 사용된 H3N2 바이러스 균주가 낮은 감염성을 보여 결과 해석이 어렵게 되었습니다.
회사는 영국 MHRA의 승인을 받기 위해 임상 연구 조직과 협력하여 등록을 연장하고 필요한 감염률을 보장하기 위한 프로토콜 수정안을 준비하고 있습니다. CC-42344는 팬데믹 조류 및 계절성 인플루엔자 A 감염에 대한 구강 치료제로 개발되고 있으며, 저항성 발달에 대한 높은 장벽을 가진 독특한 작용 메커니즘을 특징으로 합니다.
Cocrystal Pharma (NASDAQ: COCP) annonce des projets d'extension du recrutement dans son étude clinique de phase 2a pour CC-42344, son inhibiteur oral de la PB2 contre l'influenza, en raison de taux d'infection par l'influenza inattendument bas parmi les participants à l'étude. Bien que le médicament ait démontré un profil de sécurité et de tolérabilité favorable sans événements indésirables graves ni interruptions liées au médicament, la faible infectiosité du substrat viral H3N2 utilisé dans l'étude a rendu les résultats virologiques difficiles à interpréter.
L'entreprise collabore avec son organisation de recherche clinique afin de préparer un amendement de protocole pour l'approbation de la MHRA du Royaume-Uni, afin d'étendre le recrutement et d'assurer les taux d'infection nécessaires. CC-42344 est développé comme un traitement oral pour les infections par le virus de l'influenza A, tant pandémique qu'aviaire et saisonnière, avec un mécanisme d'action unique et une haute barrière au développement de résistance.
Cocrystal Pharma (NASDAQ: COCP) kündigt Pläne zur Verlängerung der Rekrutierung in ihrer Phase 2a Human-Challenge-Studie für CC-42344, ihren oralen PB2-Inhibitor für Influenza, an, da die Influenza-Infektionsraten unter den Studienteilnehmern unerwartet niedrig waren. Das Medikament zeigte ein günstiges Sicherheits- und Verträglichkeitsprofil ohne schwerwiegende Nebenwirkungen oder medikamentenbedingte Abbrüche, aber die niedrige Infektiosität des im Studium verwendeten H3N2-Virusstamms machte die virologischen Ergebnisse unverständlich.
Das Unternehmen arbeitet mit seiner klinischen Forschungsorganisation zusammen, um eine Protokolländerung für die Genehmigung durch die MHRA im Vereinigten Königreich vorzubereiten, um die Rekrutierung zu verlängern und notwendige Infektionsraten zu gewährleisten. CC-42344 wird als orale Behandlung für pandemische Vogel- und saisonale Influenza-A-Infektionen entwickelt und bietet einen einzigartigen Wirkmechanismus mit einer hohen Barriere gegen die Entwicklung von Resistenzen.
- Favorable safety and tolerability profile with no serious adverse events
- No drug-related discontinuations in the study
- Drug shows high barrier to developing resistance
- Study extension required due to low infection rates
- Current virology results are uninterpretable
- Delay in study completion and additional costs due to required protocol amendment
Insights
The Phase 2a study extension for CC-42344 reveals significant challenges in the trial design, specifically with the insufficient viral infection rates among challenged participants. This development carries several implications:
The low infectivity rate of the H3N2 viral strain used in the challenge study makes it impossible to properly evaluate the drug's antiviral efficacy. While the safety profile appears promising with no serious adverse events, the core objective of demonstrating antiviral activity cannot be met with the current dataset.
From a clinical development perspective, this setback will likely result in:
- Extended timeline for program completion
- Additional costs for recruiting new participants
- Potential protocol modifications to ensure adequate viral challenge
The silver lining is the favorable safety data, which partially de-risks the program. However, the study extension will delay potential commercialization timelines and require additional capital allocation, particularly concerning for a small-cap company with resources.
This development presents material concerns for COCP's near-term outlook. The study extension will have significant financial implications:
- Increased R&D expenses beyond initial budget projections
- Delayed potential milestone achievements
- Extended cash burn timeline
With a market cap of just
- Partnership discussions
- Investor confidence
- Future financing options
The timeline extension may necessitate additional capital raising, potentially leading to dilution for existing shareholders. This setback, while technical in nature, creates uncertainty around the program's development pathway and could pressure the stock in the near term.
- Data support favorable safety and tolerability profile with no serious adverse events (SAEs) or study-related drug discontinuations
- Enrollment to be extended due to low influenza infection among challenged participants; virology results are uninterpretable
BOTHELL, Wash., Dec. 31, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces plans to extend enrollment in the Phase 2a human challenge study with its investigational, broad-spectrum, oral influenza PB2 inhibitor CDI-42344 due to unexpectedly low influenza infection among study participants who were challenged with a H3N2 viral strain. This randomized, double-blind, placebo-controlled Phase 2a study is evaluating the safety, tolerability, pharmacokinetics (PK), antiviral activity and clinical measurements of CC-42344 at a single site in the United Kingdom.
CC-42344 is a drug candidate in development as an oral treatment for pandemic avian and seasonal influenza A infections. In December 2023, Cocrystal Pharma announced enrollment of the first patient in this study and in May 2024, the Company announced full enrollment of 78 subjects.
“While CC-42344 showed a favorable safety and tolerability profile, we’re disappointed by the low infectivity rate of the challenge influenza strain used in this study. The establishment of robust influenza infection in healthy, uninfected study subjects is critical to determine clinical endpoints for evaluating antiviral molecules. The low infectivity obtained in this study hindered antiviral data analysis,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO.
“We remain optimistic about CC-42344 due to its unique mechanism of action with a high barrier to developing resistance, which could render it a best-in-class antiviral treatment for pandemic and seasonal influenza infections. We are also encouraged by CC-42344’s favorable safety and tolerability profile from the Phase 2a study to date, with no SAEs and no drug-related discontinuations by study participants.
“We are working with the clinical research organization to prepare a protocol amendment for approval by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) in order to extend enrollment in this study, and to ensure necessary infection rates among enrolled study subjects,” he added.
About CC-42344
CC-42344 is a new class of antiviral treatment designed to effectively block an essential step in the viral replication and transcription of pandemic and seasonal influenza A and was discovered using the Company’s proprietary structure-based drug discovery platform technology. CC-42344 showed excellent in vitro antiviral activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®. In late 2022, Cocrystal reported favorable safety and tolerability results from a Phase 1 study in healthy subjects conducted in Australia. The Company initiated the Phase 2a human challenge study in December 2024 following authorization from the MHRA. In June 2024, the Company reported in vitro studies demonstrating that CC-42344 inhibited the activity of the PB2 protein in the new highly pathogenic avian influenza A (H5N1) PB2 protein recently identified in humans.
About Influenza A
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about
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 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 extension of enrollments, regulatory approval and achieving the necessary infection rate. 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 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, 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:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com
Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com
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FAQ
Why is Cocrystal Pharma (COCP) extending its Phase 2a influenza study?
What are the safety results of CC-42344 in COCP's Phase 2a trial?
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