GSK has entered into an agreement to acquire 35Pharma Inc., a Canada-based, private, clinical-stage biopharmaceutical company that develops novel protein-based therapeutics. The acquisition includes HS235, a potential best-in-class investigational medicine that has completed phase I healthy volunteer clinical trials with studies to start imminently in pulmonary arterial hypertension (PAH) and pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF).
PH is a progressive, life-shortening disease marked by high blood pressure in the lungs. Early symptoms are breathlessness, fatigue and chest pain leading to heart failure as the disease progresses. It affects approximately 82 million people worldwide across multiple disease forms, yet treatment options remain limited and the five‑year survival rate is only around 50%. By 2032, the global market for PH therapies is forecast to reach $18 billion, with activin signalling inhibitors expected to account for 50% of this.
HS235 targets the activin receptor signalling pathway, a clinically validated therapeutic target in PH. HS235 is designed with enhanced selectivity, reducing binding to BMP9 and BMP10 - ligands associated with adverse events such as bleeding and telangiectasia (broken blood vessels). By potentially lowering the risk of bleeding, HS235 may address a key limitation in current PH treatment, particularly as a significant proportion of patients require concomitant anticoagulant or antiplatelet therapy.
The underlying mechanism of HS235 offers the potential for broad metabolic benefits, including fat-selective weight loss, preservation of lean mass, and improved insulin sensitivity, supported by beneficial changes in inflammation and adipokines (fat hormones) observed in early clinical studies. These attributes may offer additional clinical and commercial value given the high prevalence of obesity and insulin resistance in the PH population.
Under the terms of the agreement, GSK will acquire 100% of the equity of 35Pharma Inc. for $950 million, payable in cash at closing.
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