COLUMBUS, OH, USA I June 01, 2023 IClarametyx Biosciences, Inc. (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced positive initial safety data from the Phase 1a portion of its clinical development program for CMTX-101, a novel immune-enabling antibody therapy designed to treat serious bacterial infections, with no safety concerns identified.
“Clearing the safety hurdle in Phase 1 is a validating milestone for accelerating development of this potentially important new tool to address persistent bacterial infections,” said David Richards, Chief Executive Officer, Clarametyx. “The sound safety findings, including the lack of anti-drug antibodies seen in the study, confirm the strength of the antibody design and support its potential to overcome the limitations of other approaches targeting biofilms and effectively resolve infection.”
No drug-related safety events were observed, no anti-drug antibodies were detected, and preliminary pharmacokinetic results align with animal modeling for CMTX-101. The safety report comes as the company moves into Phase 1b, a double-blind, randomized, placebo-controlled study that will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of CMTX-101 as an adjunctive therapy to standard‑of‑care antibiotics for the treatment of patients who have been hospitalized with moderate community-acquired bacterial pneumonia (CABP).
Additional study details and eligibility criteria can be found at www.clinicaltrials.gov, NCT05629741. Complete data from the Phase 1 portion of the study are expected in early 2024.
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, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics.
Clarametyx is separately advancing preclinical assessments of its technology as possible preventative approaches 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 and 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.
SOURCE: Clarametyx Biosciences
Post Views: 240
COLUMBUS, OH, USA I June 01, 2023 IClarametyx Biosciences, Inc. (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced positive initial safety data from the Phase 1a portion of its clinical development program for CMTX-101, a novel immune-enabling antibody therapy designed to treat serious bacterial infections, with no safety concerns identified.
“Clearing the safety hurdle in Phase 1 is a validating milestone for accelerating development of this potentially important new tool to address persistent bacterial infections,” said David Richards, Chief Executive Officer, Clarametyx. “The sound safety findings, including the lack of anti-drug antibodies seen in the study, confirm the strength of the antibody design and support its potential to overcome the limitations of other approaches targeting biofilms and effectively resolve infection.”
No drug-related safety events were observed, no anti-drug antibodies were detected, and preliminary pharmacokinetic results align with animal modeling for CMTX-101. The safety report comes as the company moves into Phase 1b, a double-blind, randomized, placebo-controlled study that will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of CMTX-101 as an adjunctive therapy to standard‑of‑care antibiotics for the treatment of patients who have been hospitalized with moderate community-acquired bacterial pneumonia (CABP).
Additional study details and eligibility criteria can be found at www.clinicaltrials.gov, NCT05629741. Complete data from the Phase 1 portion of the study are expected in early 2024.
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, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics.
Clarametyx is separately advancing preclinical assessments of its technology as possible preventative approaches 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 and 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.
SOURCE: Clarametyx Biosciences
Post Views: 240
