Merakris Therapeutics, a regenerative medicine company developing biologic therapies for hard-to-heal wounds, has secured a Type C meeting with the U.S. Food and Drug Administration scheduled for November 21, 2025. The meeting will address critical aspects of the clinical development program and manufacturing scale-up plans for MTX-001, the company's lead investigational drug candidate.
Regulatory Milestone for Wound Healing Innovation
The Type C meeting represents a formal opportunity for Merakris to engage with the FDA under its active Investigational New Drug (IND) application for treating venous leg ulcers. The virtual video conference will include multidisciplinary leadership from the FDA's Office of Therapeutic Products within the Center for Biologic Evaluation and Research, alongside representatives from Merakris' scientific, quality, and regulatory teams.
"This FDA Type C meeting is a significant regulatory milestone for progressing the MTX-001 clinical development program, as we move towards large-scale, efficient biologic drug manufacturing," said Chris Broderick, CEO of Merakris Therapeutics. "It provides us with a structured forum to align our clinical, manufacturing, and regulatory plans with the FDA's expectations, de-risking our path for completing our phase 2 and initiating phase 3 clinical trial and ultimately commercialization."
Meeting Objectives and Development Strategy
The FDA meeting will focus on several key objectives critical to MTX-001's advancement. These include chemistry, manufacturing, and controls (CMC) expectations, particularly critical quality attributes and release assays, including quantitative and functional potency assays. The discussion will also cover alignment on manufacturing scale-up and product safety testing requirements for biological drugs.
Risk-mitigation strategies will be addressed, focusing on product consistency and batch comparability, along with ongoing safety monitoring protocols. The meeting will also examine the ongoing Phase 2, double-blind, placebo-controlled study for venous leg ulcers treatment and primary safety and efficacy endpoint measures.
MTX-001 Clinical Development Progress
MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. The therapy is currently being evaluated in a multicenter Phase 2 trial (NCT04647240) for venous leg ulcers and is also available through an Expanded Access Program (EAP) for cutaneous wounds (NCT06730022).
Part 1 of the Phase 2 study, published in the International Wound Journal in March 2025, demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement. These results support the continued development of MTX-001 as a potential treatment for patients with chronic, non-healing wounds.
Commercial Manufacturing Pathway
The FDA will provide feedback on the development strategy as Merakris advances toward later-stage clinical trials and commercial-scale manufacturing. The meeting will address the path through approval of a 351(a) Biologics License Application and subsequent commercialization, representing a critical step in bringing this regenerative medicine therapy to market.
Merakris Therapeutics leverages advanced biologic manufacturing capabilities and maintains a robust research pipeline focused on improving patient outcomes and advancing the science of regenerative therapies. The company is committed to developing and commercializing biologically derived products for wound healing and other complex conditions.
