Rentschler, VarmX expand partnership to produce reverse anticoagulation drug

Rentschler Biopharma and VarmX have expanded their collaboration to support Phase III development and potential commercialization of VarmX’s VMX-C001, a coagulation therapy designed to rapidly restore clotting in patients treated with factor Xa direct oral anticoagulants (DOACs).

A global contract development and manufacturing organization (CDMO) headquartered in Germany, Rentschler will manufacture Phase III clinical supply and conduct process validation for VMX-C001 at its Milford, Massachusetts facility. The transition marks a shift from early development and GMP manufacturing previously conducted at the company’s headquarters and is intended to support a seamless move into late-stage clinical and commercial production.

VMX-C001 is a modified human factor X protein engineered to be insensitive to FXa DOACs, enabling rapid restoration of the coagulation cascade in patients requiring urgent surgery or experiencing severe bleeding, according to VarmX. The product candidate has received the FDA’s Fast Track designation and a Phase I waiver from Japan’s PMDA, reflecting the unmet need for therapies that can quickly reverse anticoagulation in emergency settings, the company said.

VarmX plans to initiate its global Phase III EquilibriX-S trial in urgent surgery in early 2026. The company also entered into a global strategic collaboration and option agreement with CSL in September 2025.

“Manufacturing readiness is key as we prepare to commence our landmark global Phase III trial,” VarmX CEO John Glasspool said in a statement. He noted that extending the partnership with Rentschler supports the company’s goal of advancing VMX-C001 toward a new treatment option for patients on FXa DOACs who require emergency surgery.

Rentschler CEO Benedikt von Braunmühl added that the expanded collaboration reflects the CDMO’s focus on long-term partnerships and continuity from development through commercialization, leveraging FDA-licensed manufacturing capabilities in both Europe and the United States.

By 2030, approximately 30 million patients across the U.S., Europe, and Japan are expected to receive FXa DOACs as chronic anticoagulation therapy, according to the companies. VMX-C001 is designed with features including universal dosing, rapid administration, and compatibility with commonly used anticoagulants such as heparin, VarmX said.

Separately, Rentschler recently announced a biologics development partnership with Coriolis Pharma to provide integrated support from early formulation through commercial manufacturing. The collaboration is intended to combine formulation, analytical, and manufacturing expertise to accelerate development timelines and reduce tech transfer risks for biologics clients, according to the companies.