November 30, 2022

Clarametyx Initiates Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101 Against Community-Acquired Bacterial Pneumonia

COLUMBUS, Ohio – November 30, 2022 – Clarametyx Biosciences Inc. (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced the initiation of its clinical development program for CMTX-101, a novel immune-enabling antibody therapy designed to treat serious bacterial infections. The technology precisely and rapidly destroys the universal underlying structure of bacterial biofilms, which undermines bacterial defenses and enables more effective antibiotic and immune interventions.

“Severe bacterial infections carry significant clinical burden and warrant new approaches that can optimize the use of available antibiotic therapies to resolve these infections and improve patient outcomes,” said Brian Murphy, MD, MPH, primary investigator of the study and Senior Vice President, Medical Department at Medpace in Cincinnati, Ohio. “Targeting the biofilm is a logical approach to address challenging respiratory infections, and this initial trial will provide useful insights into the utility of CMTX-101.”

The company will initiate a Phase 1a safety evaluation in healthy volunteers, evaluating up to four doses of CMTX-101. Following the Phase 1a period, a Phase 1b double-blind, randomized, placebo-controlled portion will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of CMTX-101 as an adjunctive therapy to standardofcare antibiotics for the treatment of patients who have been hospitalized with moderate community-acquired bacterial pneumonia (CABP). The study will also assess exploratory efficacy endpoints including hospitalization time, time to symptomatic improvement, mortality, changes in oxygen levels, and changes in relevant biomarkers. Additional study details and eligibility criteria can be found at www.clinicaltrials.gov, NCT05629741.

“A strong base of in vitro and in vivo data support the strategy behind CMTX-101 to target the biofilm itself, rending bacteria more vulnerable to immune system or antibiotic interventions,” said David Richards, Chief Executive Officer, Clarametyx. “This initial clinical data will give us a clearer picture of this treatment approach to potentially enhance therapeutic paradigms for challenging bacterial infections.”

Initiation of the study is supported by numerous preclinical studies demonstrating the anti-biofilm activity of this therapy that were included in Clarametyx’s IND that was accepted by FDA in October.

About CMTX-101

CMTX-101 is an immune-enabling antibody therapy designed to precisely and rapidly destroy the universal underlying 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 technology can be employed to treat a range of bacterial infections, many of which are characterized by the presence of multiple types of bacteria. CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and patient innate immune system effectors from the onset of CMTX-101 administration, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics.

Clarametyx and its collaborators are separately advancing preclinical assessments of this antibody technology as a possible preventative approach for other bacterial infections.

About Clarametyx Biosciences

Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response or antibiotic intervention. The Columbus, Ohio-based company is building a dynamic pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections. 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.