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Cocrystal Pharma’s Co-CEOs Highlight Pioneering Approach to Antiviral Drug Candidates Targeting Influenza and Coronaviruses as Fall Flu and COVID Season Begins

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Cocrystal Pharma (COCP) highlights its innovative approach to developing antiviral therapeutics as flu and COVID season begins. The company's candidate CC-42344 shows activity against avian influenza A PB2 protein, while current vaccines offer no protection. Phase 2a study results for CC-42344 are expected by end of 2024. The company is also conducting a Phase 1 study of CDI-988, a pan-viral drug candidate for noroviruses and coronaviruses, with results expected late 2024 or early 2025. The company's platform technology targets highly conserved viral enzymes for developing broad-spectrum antivirals against seasonal and pandemic strains.

Cocrystal Pharma (COCP) mette in evidenza il suo approccio innovativo nello sviluppo di terapie antivirali, in coincidenza con l'inizio della stagione influenzale e COVID. Il candidato dell'azienda, CC-42344, mostra attività contro la proteina PB2 dell'influenza aviaria A, mentre i vaccini attuali non offrono alcuna protezione. I risultati dello studio di Fase 2a per il CC-42344 sono attesi entro la fine del 2024. L'azienda sta anche conducendo uno studio di Fase 1 su CDI-988, un candidato farmaco pan-virale per i norovirus e i coronavirus, con risultati attesi alla fine del 2024 o all'inizio del 2025. La tecnologia della piattaforma dell'azienda mira a miri a enzimi virali altamente conservati per sviluppare antivirali ad ampio spettro contro ceppi stagionali e pandemici.

Cocrystal Pharma (COCP) destaca su enfoque innovador en el desarrollo de terapias antivirales, con el inicio de la temporada de gripe y COVID. El candidato de la empresa, CC-42344, muestra actividad contra la proteína PB2 de la influenza aviar A, mientras que las vacunas actuales no ofrecen protección. Se esperan los resultados del estudio de Fase 2a para CC-42344 para finales de 2024. La empresa también está llevando a cabo un estudio de Fase 1 de CDI-988, un candidato a fármaco pan-viral para norovirus y coronavirus, con resultados esperados a finales de 2024 o principios de 2025. La tecnología de la plataforma de la empresa se dirige a enzimas virales altamente conservadas para desarrollar antivirales de amplio espectro contra cepas estacionales y pandémicas.

Cocrystal Pharma (COCP)는 독감 및 COVID 시즌이 시작됨에 따라 항바이러스 치료제를 개발하는 혁신적인 접근 방식을 강조합니다. 회사의 후보물질인 CC-42344는 조류 인플루엔자 A PB2 단백질에 대한 활성을 보이며, 현재의 백신은 보호 효과가 없습니다. CC-42344에 대한 2상(Phase 2a) 연구 결과는 2024년 말에 발표될 예정입니다. 또한, 회사는 노로바이러스 및 코로나바이러스를 위한 범유행 항바이러스 약물 후보인 CDI-988에 대한 1상 연구를 진행 중이며, 결과는 2024년 말 또는 2025년 초에 예상됩니다. 회사의 플랫폼 기술은 계절성 및 팬데믹 균주에 대한 광범위한 항바이러스제를 개발하기 위해 고도로 보존된 바이러스 효소를 표적으로 합니다.

Cocrystal Pharma (COCP) met en avant son approche innovante dans le développement de thérapies antivirales, alors que la saison de la grippe et du COVID commence. Le candidat de l'entreprise, CC-42344, montre une activité contre la protéine PB2 de l'influenza aviaire A, tandis que les vaccins actuels n'offrent aucune protection. Les résultats de l'étude de Phase 2a pour CC-42344 sont attendus d'ici la fin de 2024. L'entreprise mène également une étude de Phase 1 sur CDI-988, un candidat médicament pan-viral pour les norovirus et les coronavirus, avec des résultats attendus fin 2024 ou début 2025. La technologie de la plateforme de l'entreprise cible des enzymes virales hautement conservées pour développer des antiviraux à large spectre contre les souches saisonnières et pandémiques.

Cocrystal Pharma (COCP) hebt seinen innovativen Ansatz zur Entwicklung antiviraler Therapien hervor, da die Grippe- und COVID-Saison beginnt. Der Kandidat des Unternehmens, CC-42344, zeigt Aktivität gegen das PB2-Protein des aviären Influenzavirus A, während die aktuellen Impfstoffe keinen Schutz bieten. Die Ergebnisse der Phase-2a-Studie für CC-42344 werden bis Ende 2024 erwartet. Das Unternehmen führt auch eine Phase-1-Studie zu CDI-988 durch, einem pan-viralen Arzneimittelkandidaten gegen Noroviren und Coronaviren, wobei die Ergebnisse für Ende 2024 oder Anfang 2025 erwartet werden. Die Plattformtechnologie des Unternehmens richtet sich auf hochkonservierte virale Enzyme, um Breitbandantiviren gegen saisonale und pandemische Stämme zu entwickeln.

Positive
  • CC-42344 shows in vitro activity against avian influenza A PB2 protein
  • Phase 2a study for CC-42344 progressing with results expected by end of 2024
  • Phase 1 study of CDI-988 advancing with results expected late 2024/early 2025
  • Platform technology enables efficient and cost-effective drug development
Negative
  • None.

Insights

The development of CC-42344 represents a significant scientific advancement in addressing both seasonal and pandemic influenza strains, particularly given the recent H5N1 avian influenza outbreak. The compound's demonstrated ability to bind to the highly conserved PB2 region of avian influenza shows promising potential against emerging pandemic threats.

Key technical differentiators include:

  • Activity against strains resistant to existing antivirals like Tamiflu® and Xofluza®
  • Novel mechanism targeting the essential PB2 site of influenza polymerase
  • Potential effectiveness against pandemic strains where current vaccines offer no protection

The Phase 2a human challenge study results expected by end of 2024 will be important in validating this approach. The concurrent development of CDI-988 for norovirus and coronaviruses adds significant pipeline value, targeting an estimated $60 billion market opportunity in norovirus alone.

While COCP's platform technology and pipeline show promise, investors should note several critical factors:

  • Small market cap of $18.5 million suggests significant undervaluation if clinical trials succeed
  • Dual program approach (influenza and norovirus/coronavirus) provides multiple shots on goal
  • Near-term catalysts with topline data expected for both lead programs by early 2025

However, the company's small size means substantial dilution risk to fund late-stage development. Partnership opportunities may emerge if Phase 2a data is positive, particularly given the growing concern over pandemic preparedness. The platform's efficiency in drug development could attract larger pharmaceutical companies looking to expand their antiviral portfolios.

The Company’s antiviral candidate for seasonal and pandemic influenza shows in vitro activity against the avian influenza A PB2 protein, whereas current influenza vaccines offer no protection against pandemic avian influenza

BOTHELL, Wash., Oct. 31, 2024 (GLOBE NEWSWIRE) -- As the fall seasonal influenza and COVID season gets underway in the Northern Hemisphere, Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) highlights the ability of the Company’s innovative structure-based drug discovery platform technology to discover and develop novel broad-spectrum antivirals therapeutics to treat a wide range of viral diseases, including newly emerging pandemic strains such as recent H5N1 avian influenza identified in the US.

“As our nation enters the fall flu and COVID season and learns of the emerging highly pathogenic avian H5N1 influenza A strain in dairy cattle and humans, the need for more effective antivirals is clear. Current flu vaccines are developed for seasonal influenza strains, not for pandemic avian influenza strains. Also, treatment-emergent resistance to approved antivirals and transmission of resistant viruses has been a challenging issue,” said Sam Lee, PhD, President and co-CEO of Cocrystal. “For example, the widespread oseltamivir (Tamiflu®) resistance of the pandemic avian influenza strains could create a serous public health situation. Clearly, there continues to be an unmet need for therapeutics with a high barrier to resistance.

“We believe our approach makes it possible to develop highly effective therapeutics for noroviruses, coronaviruses and influenza A because we target the highly conserved, essential function of viral enzymes, regardless of whether the strain is seasonal or pandemic,” he added. “We recently revealed the high-resolution cocrystal structure of the avian influenza PB2 protein complexed with CC-42344, further confirming that our PB2 inhibitor CC-42344 binds to its highly conserved PB2 region, indicating activity against this strain.”

Cocrystal’s platform utilizes Nobel Prize-winning technology to develop a new class of direct-acting antivirals that work against enzymes that are essential for viral replication. The Company is evaluating its oral CC-42344 in a Phase 2a study in healthy subjects infected with a seasonal influenza A strain. Topline safety and tolerability results from this trial are expected by the end of 2024, and preparations are underway for an Investigational New Drug (IND) application to conduct a late-stage clinical study with CC-42344 in the U.S.

The Company is also conducting a Phase 1 study with its oral protease inhibitor CDI-988, the first pan-viral drug candidate in clinical evaluation for both noroviruses and coronaviruses. Topline safety and tolerability results of the multiple-ascending cohorts are expected late this year or early next year. There is no approved vaccine or antiviral for norovirus. Norovirus is highly contagious and is the most common cause of acute gastroenteritis, which has gained notoriety for outbreaks in closed quarters such as on cruise ships and in nursing homes. According to the Centers for Disease Control and Prevention (CDC), an estimated 685 million cases and an estimated 200,000 deaths are attributed to norovirus each year worldwide, with an estimated societal cost of approximately $60 billion.

“We view the next viral pandemic as a question of timing as seasonal viruses like flu and COVID continue to evolve,” said James Martin, CFO and co-CEO of Cocrystal. “Our proprietary technology platform allows us to efficiently discover and develop potent, broad-spectrum, effective antiviral drug candidates for pandemic and seasonal outbreaks relatively quickly and far less costly than traditional approaches to drug development. As a small company, Cocrystal is highly efficient in utilizing our groundbreaking technology to develop differentiated antivirals for high-value indications with the goal of improving people’s lives.”

Avian Influenza
A multistate outbreak of highly pathogenic avian influenza in dairy cows was initially reported in March 2024. This is the first time that avian flu viruses were found in cows, with outbreaks now confirmed in herds in 14 states. In April 2024 the CDC confirmed an avian flu infection in a person exposed to dairy cows that were presumed to be infected with the virus. This is believed to be the first instance of likely mammal to human spread of this virus. In September 2024 the CDC reported the first human case of avian influenza without a known occupational exposure to sick or infected animals. As of October 30, 2024, the CDC has reported 36 human cases of this highly pathogenic avian influenza A in the U.S. during 2024.

The CDC analyzed blood collected from people of all ages in all 10 Health & Human Services regions during the 2022-2023 and 2021-2022 flu seasons. These samples were challenged with the avian flu subtype H5N1 virus to determine whether there was an antibody reaction. Data from this study suggest that there is extremely low to no population immunity to clade 2.3.4.4b A (H5N1) viruses in the U.S. Antibody levels remained low regardless of whether or not participants received a seasonal flu vaccination, meaning that seasonal flu vaccination did not produce antibodies to avian flu H5N1 viruses. 

Antiviral Influenza Candidate CC-42344
CC-42344 is Cocrystal’s novel, broad-spectrum investigational antiviral candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in influenza A’s viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential to replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology.

Cocrystal is evaluating safety, viral and clinical measures of oral CC-42344 in healthy volunteers who are challenged with influenza A in a Phase 2a human challenge study underway in the United Kingdom. CC-42344 was advanced into this study following favorable safety and tolerability results reported in a Phase 1 study in healthy volunteers conducted in Australia. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety profiles.

Cocrystal used its structure-based platform to determine the high resolution X-ray crystal structure of the recent avian influenza A (H5N1) PB2 protein, and confirmed activity of CC-42344 in vitro (NIH GeneBank ID:influenza A/Texas/37/2024(H5N1). The crystal structure of the avian influenza A (H5N1) PB2 protein showed new mutations located outside the PB2 active site. Subsequent studies showed that CC-42344 binds to the active site of the avian influenza A (H5N1) PB2 protein as previously demonstrated with the pandemic and seasonal influenza A PB2.

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 potential efficacy of Cocrystal’s product candidates against certain viruses, ongoing research and development efforts including the expected timing of clinical studies and topline results for such product candidates, and the potential market for such product candidates. 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

When will Cocrystal Pharma (COCP) release Phase 2a results for CC-42344?

Cocrystal Pharma expects to release topline safety and tolerability results from the Phase 2a study of CC-42344 by the end of 2024.

What is Cocrystal Pharma's (COCP) CC-42344 being developed for?

CC-42344 is being developed as a broad-spectrum antiviral candidate for the treatment of both pandemic and seasonal influenza A.

What are the expected results timeline for Cocrystal's (COCP) CDI-988 Phase 1 study?

Topline safety and tolerability results for the Phase 1 study of CDI-988 are expected late 2024 or early 2025.

How does Cocrystal Pharma's (COCP) CC-42344 work against influenza?

CC-42344 inhibits influenza A viral replication by binding to a highly conserved PB2 site of the influenza polymerase complex that is essential for replication.

Cocrystal Pharma, Inc.

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