Pharmazz has initiated its pivotal Phase 3 RESPECT-ETB trial evaluating sovateltide, a first-in-class endothelin-B receptor agonist, in acute cerebral ischemic stroke. The trial aims to enroll 514 patients across US, German, Spanish, and UK sites, using a Special Protocol Assessment agreed upon with the FDA. The primary endpoint is functional independence (mRS 0-2) at 90 days post-stroke.
This trial marks a critical step for Pharmazz, following a recent $25 million equity investment from Sun Pharmaceuticals, earmarked to fund this Phase 3 study. The company seeks to replicate positive data from an earlier Phase 3 trial conducted in India, which demonstrated significant improvements over the standard of care. This previous success served as the basis for sovateltide’s regulatory approval in that market.
Pharmazz is strategically positioning sovateltide to address a significant unmet need in stroke care. The absence of novel non-thrombolytic therapies approved by the FDA in over three decades underscores the clinical and commercial potential. Sovateltide’s unique mechanism, promoting neurovascular remodeling through neurogenesis, angiogenesis, and enhanced mitochondrial function, differentiates it from existing interventions. This neuroprotective approach represents a departure from solely focusing on reperfusion strategies.
The trial’s multinational design reflects the global burden of stroke and allows Pharmazz to gather data across diverse patient populations. This aligns with increasing regulatory emphasis on demonstrating efficacy across broader demographics and potentially streamlines future global registration strategies. The choice of functional independence as the primary endpoint directly addresses patient-centric outcomes and aligns with the growing focus on quality of life measures in stroke care.
Looking ahead, the success of the RESPECT-ETB trial hinges on replicating the positive signals observed in the Indian study within a larger, more diverse patient cohort. Further investigation into long-term efficacy beyond the 90-day endpoint will be critical for establishing the drug’s value proposition. Pharmazz will need to demonstrate a compelling clinical profile to justify potential premium pricing in a cost-conscious healthcare landscape. While the SPA provides a regulatory roadmap, navigating potential variations in stroke subtypes and healthcare systems across different countries will present ongoing challenges.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
