Merakris Advances Potentially Pivotal MTX-001 Phase 2/3 Strategy Following FDA Pre-IND Meeting

FDA indicates proposed double-blind Phase 2/3 design could be considered adequate and well controlled as Merakris prepares its first commercial-pilot GMP drug lot for a potentially pivotal trial.

RESEARCH TRIANGLE PARK, N.C., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Merakris Therapeutics, Inc., a clinical-stage biotechnology company developing regenerative biologic medicines, today announced receipt of the U.S. Food and Drug Administration’s (FDA) official summary of its October 16, 2026 Type B pre-Investigational New Drug (pre-IND) meeting for MTX-001 in diabetic foot ulcers (DFUs). The proposed seamless, adaptive Phase 2/3 trial is intended to support a potential future Biologics License Application (BLA).

Following clarification that the trial would be double-blind, FDA stated that the design could be considered adequate and well controlled in that context. The complete protocol and statistical analysis plan remain subject to review.

“FDA's feedback provides important clarity as we align our proposed adaptive Phase 2/3 trial with a GMP manufacturing program designed to support future registration," said Chris Broderick, Chief Executive Officer of Merakris. "We believe this integrated strategy offers a meaningful opportunity to accelerate evidence generation and deploy development capital more efficiently.”

Potential Single-Trial Registration Strategy

Merakris plans to submit a dedicated DFU IND, separate from its ongoing clinical program in venous leg ulcers (VLUs). The proposed seamless, adaptive Phase 2/3 study is designed to integrate a rigorous clinical and statistical framework with a commercially representative GMP manufacturing strategy intended to support future registration.

Merakris intends to leverage its first commercial-pilot-scale GMP drug lot as clinical supply for the proposed study, alongside additional planned GMP lots designed to establish manufacturing consistency and support future registration. Subject to FDA review of the clinical, statistical and manufacturing evidence, this coordinated approach may allow qualifying early-stage clinical data to contribute to a pivotal evidence package, potentially reducing duplication between conventional Phase 2 and Phase 3 development.

The proposed adaptive design incorporates prespecified interim analyses that may permit early stopping for efficacy or futility, or continuation to a larger planned sample size. FDA described the proposed sample-size selection analyses as reasonable and confirmed that no additional nonclinical studies are required to support the DFU investigation. Merakris' strategy is informed by FDA draft guidance recognizing that one adequate and well-controlled investigation, together with confirmatory evidence, may support marketing approval under appropriate circumstances.

GMP Manufacturing Readiness

FDA also provided feedback on MTX-001 product characterization and manufacturing. The Agency indicated that the overall proposed critical quality attributes appeared reasonable and requested data from future GMP-manufactured lots demonstrating consistent product quality. Merakris plans to incorporate this guidance into its clinical supply and manufacturing activities, including additional analytical qualification and viral-safety documentation.

Clinical Pipeline and Capital Strategy

In parallel, Merakris continues its randomized, double-blind, placebo-controlled Phase 2 study of MTX-001 in patients with chronic, non-healing VLUs (NCT04647240). The study is designed to evaluate safety and efficacy, with primary completion anticipated in the first quarter of 2027, subject to clinical execution. MTX-001 received FDA Fast Track designation for the VLU indication in June 2026.

The DFU program is supported in part by an NIH Direct-to-Phase II Small Business Innovation Research (SBIR) award providing up to approximately $2.2 million over two years. Merakris expects additional capital will be required for GMP manufacturing and the proposed Phase 2/3 trial and is evaluating financing and strategic collaboration opportunities aligned with these milestones.

Beyond its lead chronic wound indications, Merakris is also conducting exploratory evaluations of MTX-001 in additional conditions involving inflammation and impaired tissue repair, with the objective of identifying future therapeutic development opportunities.

About MTX-001

MTX-001 is an investigational biological drug derived from human amniotic fluid, currently being developed by Merakris for the treatment of chronic, non-healing wounds. The Company is evaluating MTX-001 in an ongoing Phase 2 clinical study in venous leg ulcers and advancing regulatory preparations for a proposed adaptive Phase 2/3 study in diabetic foot ulcers.

MTX-001 is investigational and has not been approved by FDA for any indication.

About Merakris Therapeutics

Merakris Therapeutics, Inc. is a clinical-stage regenerative medicine company developing biologic therapies for chronic wounds and other areas of tissue repair. The Company’s lead investigational biologic, MTX-001, is currently being evaluated in venous leg ulcers and is being advanced for development in diabetic foot ulcers. Merakris also develops and commercializes regenerative technologies across selected surgical and wound-care markets.

NIH Funding Acknowledgement

Merakris Therapeutics has been awarded research funding from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number R44DK146625 to support planned research activities in diabetic foot ulcers. The FDA pre-IND meeting described in this announcement was not funded by NIH. The content of this announcement is solely the responsibility of Merakris Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

Merakris Forward-Looking Statements

This release contains forward-looking statements concerning MTX-001, the proposed adaptive Phase 2/3 trial, potential regulatory pathways, manufacturing development, future clinical milestones, and anticipated financing and strategic activities. These statements involve risks and uncertainties, including the possibility that FDA may require changes to the proposed study or additional evidence; that clinical results may not demonstrate safety or efficacy; that manufacturing qualification, lot consistency or comparability requirements may not be met; that development timelines may change; and that financing or strategic arrangements may not be available on acceptable terms. Actual results may differ materially from those expressed or implied. FDA has not authorized initiation of the proposed DFU study, agreed that one trial will be sufficient for a future Biologics License Application, or approved MTX-001. Readers should not place undue reliance on these forward-looking statements.

Contact:
Chad Ingulsrud, MBA
Investor Relations
cingulsrud@merakris.com