Drugs / CMTX-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05629741 | Nov 2022 → Aug 2024 | bacterial pneumonia | Clarametyx Biosciences, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT06159725 | Jun 2024 → Nov 2025 | cystic fibrosis | Clarametyx Biosciences, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-01-09 | Clarametyx Biosciences, Inc. | Results Clarametyx Biosciences Announces Positive Topline Data from Phase 2a Study Evaluating CMTX-101 in Cystic Fibrosis clarametyx.com ↗ |
| 2025-08-04 | Clarametyx Biosciences, Inc. | Regulatory Clarametyx Biosciences Announces FDA Grant of Fast Track And Qualified Infectious Disease Product Designations For CMTX-101 clarametyx.com ↗
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. |
| 2025-06-16 | Clarametyx Biosciences, Inc. | Results Clarametyx Biosciences Announces Positive Interim Analysis in Phase 2a Study Evaluating CMTX-101 for Infections Associated with Cystic Fibrosis clarametyx.com ↗
Clarametyx Biosciences Inc . (“Clarametyx”), a clinical-stage biotechnology company developing immune-enabling therapies and vaccines to address biofilm-driven chronic respiratory diseases, announced today that it is advancing a Phase 1b/2a clinical trial evaluating its novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections, based on the DMC’s approval to proceed following results of a pre-specified interim analysis. |
| 2024-10-17 | Clarametyx Biosciences, Inc. | Results Clarametyx Biosciences Announces Progress on Study of Antibody Therapy CMTX-101 For Infections Associated With Cystic Fibrosis clarametyx.com ↗
We are encouraged by the initial data from the 1b portion of the study, which demonstrated no safety signals with CMTX-101. |
| 2023-06-01 | Clarametyx Biosciences, Inc. | Results Clarametyx Announces Positive Early Phase 1 Safety Findings on CMTX-101, Immune-Enabling Antibody Therapy clarametyx.com ↗
Clarametyx 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. |
| 2022-10-05 | Clarametyx Biosciences, Inc. | Regulatory Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101 clarametyx.com ↗
Clarametyx Biosciences Inc . (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CMTX-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06159725 ↗ |
| Modality | Monoclonal antibody | “CMTX-101 is a bacterial biofilm disrupting monoclonal antibody” NCT05629741 ↗ |
| Route | Intravenous | “single IV infusion” NCT05629741 ↗ |