CMTX-101 / Clarametyx Biosci - LARVOL DELTA

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=43 | Completed | Sponsor: Clarametyx Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=41 | Active, not recruiting | Sponsor: Clarametyx Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Clarametyx Biosciences Announces FDA Grant of Fast Track and Qualified Infectious Disease Product Designations for CMTX-101 (Businesswire) - "Clarametyx Biosciences, Inc...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...'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.'"

Enrollment status • Fast track • Financing • IND • Cystic Fibrosis

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: Clarametyx Biosciences, Inc. | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Antibiotics and non-traditional antimicrobial agents for pseudomonas aeruginosa in clinical phases 1, 2, and 3 trials. (PubMed, Expert Opin Investig Drugs) - "Traditional agents in clinical development include β-lactam/β-lactamase inhibitors (funobactam, taniborbactam, QPX2014-xeruborbactam), aminoglycosides (apramycin), polymyxin derivatives (upleganan, MRX-8, and SPR741), fluoroquinolones (MP-376), and lipopolysaccharide transport inhibitors (murepavadin). Non-traditional antibiotics in clinical development include anti-virulence agents (fluorothiazinone), monoclonal antibodies (INFEX-702, TRL-1068, and CMTX-101), bacteriophages (AP-PA02, YPT-01, BX004-A, and WRAIR-PAM-CF1), and miscellaneous agents (AR-501, PLG-0206, SNSP-113, OligoG CF-5/20, and ALX-009). A considerable number of antimicrobial agents, some with novel mechanisms of action, are in clinical phases of development for treating Pseudomonas aeruginosa infections. The urgent need for more therapeutic options necessitates the rapid optimization of progress to introduce new agents into clinical practice."

Journal • Review • Infectious Disease

Clarametyx Biosciences Announces Investment by Kineticos AMR Accelerator Fund (Businesswire) - "Clarametyx Biosciences Inc....and Kineticos Life Sciences...announced an investment by the Kineticos AMR Accelerator Fund I, L.P...Aligned with the investment, KAMRA Venture Partner Douglas Thomson will join the Clarametyx Board of Directors....This investment extends the Company’s Series A funding completed in 2024 to drive momentum across the Clarametyx pipeline, including the ongoing CMTX-101 trial in cystic fibrosis-related infections in collaboration with the Cystic Fibrosis Foundation, and development of the CMTX-301 vaccine against recurrent bacterial infections, which was recently funded by CARB-X."

Financing • Cystic Fibrosis

A Study to Evaluate the Safety of CMTX-101 in People with Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: Clarametyx Biosciences, Inc. | Trial completion date: Feb 2025 ➔ Aug 2025 | Trial primary completion date: Feb 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Clarametyx Biosciences Announces Progress on Study of Antibody Therapy CMTX-101 for Infections Associated With Cystic Fibrosis (Businesswire) - "Clarametyx Biosciences....today announced that it has completed the initial Phase 1b portion of its clinical trial evaluating the novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections and is now initiating the Phase 2a portion of the trial....'We are encouraged by the initial data from the 1b portion of the study, which demonstrated no safety signals with CMTX-101'....The company expects to report initial findings from the study in 2025."

P1 data • Trial status • Cystic Fibrosis

A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101 (clinicaltrials.gov) - P1 | N=28 | Terminated | Sponsor: Clarametyx Biosciences, Inc. | Data currently under review. Results will be posted when final.

Trial termination • Infectious Disease • Pneumonia • Respiratory Diseases

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: Clarametyx Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A 2-Part First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of CMTX-101 (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Clarametyx Biosciences, Inc. | Trial completion date: Feb 2024 ➔ May 2024 | Trial primary completion date: Feb 2024 ➔ May 2024

Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

Clarametyx Biosciences Announces $33M Series A Financing to Advance Anti-Biofilm Biologics for Serious Bacterial Infections (BioSpace) - "Clarametyx Biosciences Inc....today announced the successful completion of a $33 million Series A round. The proceeds from the round will enable the company to accelerate efforts across its pipeline, including specifically to evaluate the potential of Clarametyx’s lead therapeutic candidate CMTX-101 to combat infection in people with cystic fibrosis (CF), a progressive, genetic disease that affects the lungs, pancreas and other organs....In coordination with the fundraising, Clarametyx has initiated a Phase 1b/2a clinical trial evaluating its lead candidate, CMTX-101, in people with CF."

Financing • Cystic Fibrosis