en.Wedoany.com Reported - Hengrui Pharma and Braveheart Bio recently announced positive progress in the Phase 2 clinical trial of their co-developed drug, HRS-1893 (also known as BHB-1893), for obstructive hypertrophic cardiomyopathy (oHCM). This multicenter, randomized, open-label dose-finding study enrolled 42 patients to evaluate the efficacy of HRS-1893 as a next-generation cardiac myosin inhibitor. The results showed that HRS-1893 treatment led to a rapid and significant reduction in left ventricular outflow tract gradient (LVOT-G), a key indicator of cardiac obstruction, highlighting its potential in treating obstructive hypertrophic cardiomyopathy.
Dr. Qi Sheng, Executive Director and Head of the Cardiovascular Division at Hengrui Pharma, stated: "Based on the current clinical data, BHB/HRS-1893 demonstrates the potential to be a differentiated treatment option for oHCM patients. We look forward to continuing our collaboration with Braveheart Bio to advance clinical development and provide better treatment options for patients worldwide." Dr. Travis Murdoch, CEO and President of Braveheart Bio, added: "These results align with best-in-class clinical characteristics and hold promise as a novel treatment option. A simplified dosing regimen could overcome the limitations of existing therapies, benefiting more patients, supporting our plans to initiate a global pivotal study in 2026."
In the study design, patients were randomly assigned to three groups receiving 12 weeks of oral HRS-1893 treatment, with doses ranging from 20 mg twice daily to 40 mg once daily, allowing for individualized adjustments based on left ventricular ejection fraction and Valsalva LVOT-G. The primary endpoint was the change in Valsalva LVOT-G from baseline to week 12. The data showed that HRS-1893 rapidly reduced LVOT-G across all groups, with minimal changes in LVEF. Complete response rates ranged from 50% to 86%, and the mean Valsalva LVOT-G fell below 30 mmHg as early as day 5. 89% of patients responded well to the 40 mg or 60 mg twice-daily regimens, with almost no need for titration. In the open-label extension phase, all patients continued medication, achieving an 88% complete response rate by week 39.
Regarding safety, HRS-1893 was generally well-tolerated, with no new safety signals identified within 12 weeks. Adverse events were mild to moderate, with no treatment discontinuations and no patients experiencing an ejection fraction below 55%. These results from the obstructive hypertrophic cardiomyopathy study were presented as a late-breaking report at the American College of Cardiology Annual Scientific Session, providing support for further development.
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