Collaboration Advances Novel Coagulation Therapy Towards Phase 3

Rentschler Biopharma and VarmX have expanded their partnership to advance VMX-C001, a novel coagulation therapy, towards Phase 3 trials and potential commercialization. This therapy aims to restore blood coagulation in patients on FXa DOACs requiring urgent surgery or experiencing severe bleeding. The manufacturing will transition from Rentschler Biopharma's German site to its Milford, MA facility, underscoring the partnership's seamless progression to late-stage clinical and commercial production.

VMX-C001 has gained momentum with an FDA Fast Track Designation and a Phase 1 waiver from Japan's PMDA. The therapy, a modified human factor X protein, bypasses FXa DOACs' anticoagulant effects to restore coagulation. The upcoming global Phase 3 EquilibriX-S trial will evaluate its efficacy in patients undergoing emergency surgery while on FXa DOACs.

VarmX CEO John Glasspool emphasized the importance of manufacturing readiness for the trial, while Benedikt von Braunmühl, CEO of Rentschler Biopharma, highlighted the company's commitment to supporting the therapy's commercialization. By 2030, it is anticipated that 30 million patients across major markets will be on FXa DOACs, many of whom may benefit from VMX-C001 during emergencies.