- Pre-clinical and clinical studies established zapnometinib`s capacity as a broad spectrum therapy for the treatment of severe RNA virus infections.
- Zapnometinib is now ready for clinical development in severe influenza, an area without approved therapies and with a rapidly evolving pandemic threat from bird flu virus H5N1.
- Key claims granted by US Patent Office providing for further clear differentiation and broad coverage within Atriva`s therapeutic focus areas.
- Claims include treatment of bacterial and viral infections with zapnometinib.
MARTINSRIED, Germany, June 06, 2024 / Biotech Newswire / -- Atriva Therapeutics, a leader in immunomodulatory and anti-viral therapies, is pleased to announce that it has been granted a US patent for its MEK inhibitor zapnometinib (ATR-002). The patent includes claims for the treatment of bacterial infections, the treatment of infections caused by any strain of influenza viruses (including bird flu H5N1), the use of ATR-002 in combination with neuraminidase inhibitors for the treatment of influenza virus infections and the use of ATR-002 for the treatment of co-infections involving influenza viruses and bacteria.
"This pertinent patent grant significantly strengthens Atriva`s patent portfolio and substantially increases its value as we are progressing zapnometinib into Phase 2 clinical development for patients hospitalized with a severe influenza infection”, said Christian Pangratz, Chief Executive Officer of Atriva Therapeutics.
Zapnometinib is an oral, non-ATP-competitive, small-molecule inhibitor of MEK1/MEK2 with immunomodulatory and antiviral properties. Atriva is continuing the development of zapnometinib in severe viral diseases with epidemic or pandemic potential such as bird flu (H5N1). As a next step, the company is aiming to confirm the promising results from the Phase 2 proof-of-concept study “RESPIRE” – conducted with patients hospitalized with a moderate to severe SARS-CoV-2 infection – in a Phase 2 clinical trial with patients hospitalized with a severe influenza infection, potentially also caused by bird flu H5N1.
The RESPIRE trial was funded by Atriva Therapeutics, the German Federal Ministry of Education and Research and co-funded by the European Investment Bank.
About the RESPIRE study
RESPIRE1 was a randomized, double-blind, placebo-controlled, international, multi-center POC (Proof of Concept) / Phase 2 clinical trial in adult patients with moderate-to-severe COVID-19. Hospitalized patients with or without supplemental oxygen at the time of screening or randomization were enrolled. On top of standard of care, patients were randomized to receive zapnometinib (ATR-002) 900 mg tablets, once daily on Day 1, followed by zapnometinib 600 mg once daily on Days 2 to 6, or to receive placebo in a matching scheme.
The study was designed to establish the efficacy of zapnometinib; the primary endpoint was clinical status score (CSS) on Day 15, using a seven-point ordinal scale as recommended by the WHO COVID-19 Therapeutic Trial Synopsis.2 Secondary endpoints included time to hospital discharge, changes in clinical signs and symptoms and other relevant clinical parameters. All patients were followed-up for 90 days.
About zapnometinibv
About Atriva Therapeutics
Atriva Therapeutics’ mission is to develop an antiviral and immunomodulatory therapy platform against severe respiratory and systemic diseases with a high unmet medical need induced by RNA viruses, e.g., influenza, COVID-19, RSV (Respiratory Syncytial Virus) and Dengue. The clinical-stage biopharmaceutical company is pioneering the development of host-targeting immunomodulatory and antiviral therapies, making development of resistance unlikely, and thereby significantly contributing to pandemic preparedness and the availability of more effective broad-spectrum antiviral therapies. The Atriva lead product zapnometinib (ATR-002) is a first-in-class, host-targeting agent that aims to inhibit viral replication and to favorably modulate the body’s immune response to RNA viruses. Ten active patent families with broad international coverage grant protection for the use of MEK inhibitors and other kinase inhibitors for antiviral therapies through 2041. Atriva Therapeutics was founded in 2015 by a team of leading scientists in viral research and seasoned industry experts and is based in Munich, Germany.
For further information, please visit www.atriva-therapeutics.com and follow us on LinkedIn and X (formerly known as Twitter).
Contact
Atriva Therapeutics GmbH
Christian Pangratz, CEO
+49 69 999916210
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References:
- Atriva Therapeutics GmbH. 2022. A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 (RESPIRE).
- https://www.who.int/publications/i/item/covid-19-therapeutic-trial-synopsis
- Pleschka S et al. Nat Cell Biol 2001 Feb 3:301-5.
- Ludwig S et al, Curr. Opin. In Virology 2023, https://doi.org/10.1016/j.coviro.2023.101304
- Haasbach E et al. Antiviral Res 2017 Jun 142:178-4.
- Laure M et al. Antiviral Res 2020 Jun 178:104806.
- Schreiber A et al. 2022. Cell Mol Life Sci. 79(1):65.
- Planz O Antiviral Res 2013 Jun 98(3):457-68.
- Pinto R et al. Antiviral Res 2011 Oct 92(1):45-56.
- Ragab D et al. 2020. Front Immunol. 11, 1446 (2020).
Keywords: Humans; Influenza, Human; Influenza A Virus, H5N1 Subtype; Neuraminidase; 2-(2-chloro-4-iodophenylamino)-N-3,4-difluorobenzoic acid; Coinfection; COVID-19; Clinical Trials, Phase II as Topic; SARS-CoV-2; RNA Viruses; Pandemics; Antiviral Agents; Bacterial Infections; Bacteria; Mitogen-Activated Protein Kinase Kinases; Biological Products; Biotechnology; Germany; Atriva Therapeutics; US Patent; MEK Inhibitor; Zapnometinib (ATR-002); Broad Spectrum Therapy; RNA Virus Infections; Bird Flu (H5N1); Pre-clinical and Clinical Studies; Severe Influenza; Bacterial Infections; Viral Infections; Neuraminidase Inhibitors; Co-infections; Christian Pangratz; Phase 2 Clinical Development; Immunomodulatory Properties; Antiviral Properties; Raf/MEK/ERK Signaling Pathway; RNA Viruses; Cytokine/Chemokine Response; Inflammatory Response; SARS-CoV-2; Orphan Drug Designation (ODD); Severe Respiratory Diseases; Pandemic Preparedness; Broad-spectrum Antiviral Therapies; Munich, Germany
Source: Biotech Newswire