Clarametyx Biosciences has commenced the Phase Ia clinical trial of its immune-enabling antibody therapy, CMTX-101, to potentially treat community-acquired bacterial pneumonia (CABP).
The trial will analyse the safety of up to four doses of the antibody in healthy subjects.
On concluding the Phase Ia portion of the trial, the company will commence the placebo-controlled, double-blind, randomised Phase Ib segment.
This Phase Ib portion will assess the safety, tolerability, pharmacokinetics, and immunogenicity of CMTX-101 as an adjunctive treatment to antibiotics standard‑of‑care to treat CABP patients admitted to the hospital with moderate disease.
In addition, the trial will evaluate exploratory efficacy endpoints such as time to symptomatic improvement, hospitalisation time, death, oxygen level variations, and changes in associated biomarkers.
The trial launch is backed by various preclinical studies where CMTX-101 showed anti-biofilm activity.
A new antibody, CMTX-101 is created for treating serious bacterial infections.
It quickly eliminates the bacterial biofilms’ universal underlying structure to subsequently weaken extracellular bacterial defences and facilitate efficient antibiotic and immune intervention.
Clarametyx CEO David Richards said: “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.
“This initial clinical data will give us a clearer picture of this treatment approach to potentially enhance therapeutic paradigms for challenging bacterial infections.”
In October this year, the company received clearance for the Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to commence a Phase I safety study, followed by a Phase Ib trial of CMTX-101.