Inventiva announces that its partner Sino Biopharm received IND approval from the NMPA to initiate clinical trial with lanifibranor in China
Friday, May 26, 2023
Daix (France), Long Island City (New York, United States), Beijing/Hong Kong (China), May 25, 2023 – Inventiva (Euronext Paris and Nasdaq: IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (“NASH”) and other diseases with significant unmet medical needs, and Sino Biopharm, through its subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (“CTTQ”), today announce that CTTQ received Investigational New Drug (“IND”) approval from the Chinese National Medical Products Administration (“NMPA”) on May 22nd 2023, and can now initiate the clinical development of Inventiva’s lead compound lanifibranor in mainland China.
Frederic Cren, CEO and cofounder of Inventiva, stated: “We are extremely pleased by this positive feedback from the NMPA, which allows our lead compound to advance into a Phase III clinical trial in NASH in mainland China. This is an important milestone for us and our partner Sino Biopharm, and brings new opportunities for patients affected by NASH in China to participate in the global NATiV3 Phase III clinical trial. We are looking to successfully develop lanifibranor with Sino Biopharm and potentially commercialize in China the first oral treatment for patients with NASH.”
Philip Duong, Head of Overseas BD & Alliance, Sino Biopharm: “We are delighted to have received the IND approval from the Chinese NMPA. This positive step brings us one step closer to potentially bringing a NASH product candidate to patients with NASH in China, a growing and devastating disease with no product currently approved. With its broad mechanism of action acting on the spectrum of NASH disease, we believe that lanifibranor could potentially be one of the best-in-class treatments for the estimated 32 million patients with NASH in China. Our entire team is now looking forward to next steps and participating in NATiV3.”
Under the proposed clinical program, CTTQ will enrol patients from China in the global ongoing NATiV3 Phase III clinical trial, which, if positive, is expected to support a potential New Drug Application (“NDA”) filing in China, the United States and Europe. In addition, CTTQ will also conduct in parallel a Phase I clinical pharmacology study to evaluate the pharmacokinetics of the 800mg/day and 1200mg/day doses of lanifibranor in healthy Chinese subjects. CTTQ will be responsible for all costs linked to lanifibranor development in China. Following the IND approval, Inventiva is eligible to the first of the 2 short term milestones amounting to a total of $5 million, under the license and collaboration agreement with CTTQ.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with NASH, mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva’s lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies.
Inventiva’s pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva’s decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting an oncology development candidate for its Hippo signalling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly-owned research and development facility.
Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
About Sino Biopharm
Sino Biopharm is a leading, innovative R&D-driven pharmaceutical conglomerate in China. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. Sino Biopharm’s products have gained a competitive foothold in various therapeutic categories with promising potential, comprising a variety of biopharmaceutical and chemical medicines for oncology, surgery/orthopedics, liver disease, and respiratory system. The collaboration with Inventiva is managed by invoX Pharma Limited (“invoX”), a wholly owned subsidiary of Sino Biopharm, headquartered in the United Kingdom. invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China.
For further information about Sino Biopharm, please visit: http://www.sinobiopharm.com/.
About lanifibranor
Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (PPAR) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the most advanced pan-PPAR agonist in clinical development for the treatment of NASH. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.
