PITTSBURGH and BOSTON, May 1, 2025 – Synhale Therapeutics Inc. (Synhale), a virtual biotech firm focused on advancing treatments for
Pulmonary Hypertension (PH), has announced its acquisition of
Telaglenastat (CB-839), a pioneering
glutaminase inhibitor. With this acquisition, Synhale is poised to initiate a Phase 2 clinical program targeting PH Groups 1 through 4.
Chad D. Holland, the President & CEO of Synhale, emphasized that this acquisition provides a significant opportunity to gather clinical data on a condition that carries high mortality and presents a vast market opportunity. Holland stressed that Synhale's approach, leveraging Telaglenastat's previous human clinical data, seeks to fast-track the introduction of transformative therapies to patients while ensuring optimal value for shareholders.
Stephen Chan, MD, PhD, and Founder of Synhale, highlighted the pressing need for innovative PH treatments, especially in Groups 2 and 3, which include patients with
heart failure with preserved ejection fraction (HFpEF) and
chronic lung disease. PH associated with HFpEF has a five-year mortality rate nearing 50%, a statistic that mirrors the grim outcomes in
chronic obstructive pulmonary disease (COPD) and other lung disorders. By targeting glutaminase activity, Synhale aims to tackle a critical metabolic pathway across all PH groups, offering a new avenue of hope for patients with limited treatment options.
Pulmonary Hypertension is a severe disorder marked by the restructuring and hardening of the pulmonary vasculature. It becomes particularly life-threatening when it occurs alongside other health conditions, significantly raising the risk of mortality. The current classification systems for PH do not adequately account for its molecular drivers, resulting in gaps in treatment options. Synhale's strategy with Telaglenastat focuses on elevated glutaminase activity, which is a major contributor to
vascular, cardiac, and pulmonary disorders. This approach has the potential to benefit not only the rare Pulmonary Arterial Hypertension (Group 1) and chronic thromboembolic disease (Group 4) but also the more common forms of PH associated with heart failure (Group 2) and chronic lung disease (Group 3).
Previously, Telaglenastat was administered to over 800 patients during its development for oncology applications, and it is now ready to enter Phase 2 trials with substantial preclinical data supporting its potential for PH treatment. Synhale is preparing to tap into a market opportunity estimated between $12 billion and $24 billion across PH Groups 1 to 4.
Holland also shared that Synhale is preparing for another round of fundraising to propel Telaglenastat through essential clinical milestones. The company’s virtual operating model is designed to be cost-effective while leveraging top-tier expertise to deliver breakthrough treatments for patients suffering from PH.
Synhale Therapeutics Inc. is committed to revolutionizing the treatment of Pulmonary Hypertension by focusing on elevated glutaminase activity, which plays a critical role in vascular stiffness, fibrosis, and cellular proliferation. The company's mission is to transform PH treatment by developing therapies that directly target the underlying mechanisms of the disease.
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