US-based Clarametyx Biosciences is starting the enrolment for its Phase Ib/IIa trial investigating CMTX-101 as an adjunctive therapy for patients with cystic fibrosis (CF), CEO David Richards has confirmed.
The Phase Ib/II trial (NCT06159725), which is being supported by the Cystic Fibrosis Foundation, will evaluate the safety of CMTX-101 in people with stable CF and chronic infection in the US. Patients in the trial will receive CMTX-101 alongside tobramycin for 28 days.
Richards told the Clinical Trials Arena that CMTX-101 is a precision anti-biofilm candidate, which enhances antibiotic sensitivity and could as a result reduce rates of antibiotic resistance. The candidate acts against DNABII protein, rapidly disrupts biofilms and releases the resident bacteria, which promotes clearance by either host immune effectors or antibiotics.
The Phase Ib stage will be an open-label, dose-escalation study involving six patients. The doses will be 5mg, 15mg, and 30mg. Richards added that enrolment for the Phase Ib cohort has started.
The interim analysis of the Phase IIa study will be a placebo-controlled study involving 19 patients who will be randomised into three groups: low dose (5mg), high dose (30mg) and placebo, in an 8:8:3 ratio. The final analysis will involve 41 patients randomised in the same groups in a 2:2:1 ratio.
Primary endpoints will measure safety and tolerability, with secondary and exploratory endpoints investigating the efficacy of the candidate.
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The company is also conducting a Phase I trial (NCT05629741) to evaluate the candidate’s safety, tolerability, pharmacokinetics, and immunogenicity. The first part involves 20 healthy volunteers, with the second part involving 16 hospitalised patients with suspected or confirmed bacterial pneumonia.
Currently, the company plans to continue investigating the candidate in CF and pneumonia, with potential expansion into other respiratory infections, including non-cystic fibrosis bronchiectasis, nontuberculous mycobacteria, and chronic obstructive pulmonary disease. The company also hopes to develop the candidate in other bacterial infections.
On 5 January, Clarametyx announced it had raised $33m in a Series A financing round. The money will be used to continue the development of CMTX-101.