August 4, 2025

Clarametyx Biosciences Announces FDA Grant of Fast Track And Qualified Infectious Disease Product Designations For CMTX-101

CLARAMETYX BIOSCIENCES ANNOUNCES FDA GRANT OF FAST TRACK AND QUALIFIED INFECTIOUS DISEASE PRODUCT DESIGNATIONS FOR CMTX-101  

Phase 1b/2a study in cystic fibrosis remains on track for full enrollment by end of 2025 following positive interim analysis announced in June

Company closes upsized Series A funding tranche to accelerate pipeline activities

COLUMBUS, Ohio – August 4, 2025 – Clarametyx Biosciences, Inc. (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, today announced that the U.S. Food and Drug Administration (FDA) has  granted Fast Track and Qualified Infectious Disease Product (QIDP) Designations under the Gaining Antibiotic Incentives Now (GAIN) Act for CMTX-101’s use to treat people with cystic fibrosis who are affected by chronic bacterial pulmonary infections. Following the recently announced positive interim analysis results in cystic fibrosis, the Company has closed an upsized second tranche of funding associated with its Series A financing from existing investors to support ongoing pipeline activities for both therapeutic and vaccine programs.

“The receipt of both Fast Track and QIDP designations from the FDA underscores CMTX-101’s potential as an innovative therapy for patients suffering from chronic respiratory conditions.  We look forward to working even closer with FDA to expedite the approval of a new therapy for patients suffering from difficult-to-treat pulmonary conditions,” said David V. Richards, Chief Executive Officer, Clarametyx. “Expanded resources and support from our valued investors enables us to advance our pipeline development efforts as we look to complete enrollment in our lead clinical study by the end of this year and continue driving our vaccine program through lead optimization activities towards a 2027 IND.”

FDA’s Fast Track Designation offers the potential for more frequent interactions with the FDA during clinical development and, potentially, accelerated approval and/or priority review. QIDP Designation provides incentives for the development of new infectious disease technologies, including priority review and eligibility for an additional five years of market exclusivity. These designations are intended to support the development of new therapies that address serious or life-threatening infections caused by resistant pathogens.

The company’s ongoing Phase 1b/2a clinical trial is evaluating CMTX-101 on top of stable, background standard of care therapy in people with CF, evaluating safety and tolerability, pharmacokinetics, immunogenicity, reduction of pulmonary Pseudomonas aeruginosa burden, and additional exploratory endpoints. A recently announced interim analysis from the first 21 participants enrolled met the pre-specified criteria to proceed, and the next portion will expand the number of participants and sites active in the trial. More information is available at ClinicalTrials.gov (http://www.clinicaltrials.gov, NCT06159725).

About CMTX-101

CMTX-101 is an investigational immune-enabling antibody therapy in development to address chronic respiratory disease exacerbation and lung function decline. The therapy is designed to precisely and rapidly destroy the universal underlying, pro-inflammatory structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present across bacteria, the approach can treat a range of bacterial infections and pathogen types. The goal of treatment is to dramatically improve the effectiveness of innate immune system effectors and antibiotic therapies, thereby addressing inflammation pathways driven by the biofilm state. It is currently in development in cystic fibrosis, with opportunities to expand to other chronic respiratory disease areas including non-CF bronchiectasis (NCFB), nontuberculous mycobacterial (NTM) lung disease, and chronic obstructive pulmonary disease (COPD).

About Clarametyx Biosciences

Clarametyx Biosciences is combating the formidable challenge of chronic, recalcitrant respiratory disease decline through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines, including CMTX-101, which is in a Phase 2a study for infections associated with cystic fibrosis, and CMTX-301, an anti-biofilm vaccine in early development. For more information, visit us on the web or on LinkedIn.

Media Contact:
Kellie Hotz
khotz@clarametyx.com
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Clarametyx Expanded Access Policy

Clarametyx Biosciences is a clinical stage biopharmaceutical company committed to developing novel immune-enabling therapies for serious or difficult-to-treat respiratory diseases.

“Expanded access” refers to use of an investigational drug outside of a clinical trial, where the use of the drug is for treatment, rather than gathering data in support of a marketing application.

The main goal of ongoing clinical trials for our investigational agent, CMTX-101, is to gain information about the drug’s safety and efficacy to submit an application to Health Authorities in support of approval to market CMTX-101. For this reason, Clarametyx believes that direct enrollment in a clinical trial is the preferred route of access to a drug, for which we are continuing to develop data on safety, efficacy and tolerability. We believe expanded access outside of a clinical trial may interfere with the conduct of ongoing trials and may disrupt the progress of our development programs, which could potentially delay access to other patients in need.

For this reason, Clarametyx is not making its investigational drugs available on an expanded access basis at the present time. We plan to re-evaluate this policy in the future as additional information becomes available from ongoing clinical trials.

If you have any questions about this policy or would like information about how to participate in our clinical studies, please contact us at info@clarametyx.com. More information on our ongoing clinical trial is available at ClinicalTrials.gov (http://www.clinicaltrials.gov, NCT06159725).

As authorized by the 21st Century Cures Act, Clarametyx may revise this expanded access policy at any time.