cystetic Medicines, Inc., a US-based clinical-stage biotechnology company, announced on Monday it has dosed its first healthy volunteer with CM001 in a Phase one clinical trial.
CM001 is a molecular prosthetic aimed at the treatment of people with cystic fibrosis (CF).
The randomised, double-blind, placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of single-ascending and then multiple-ascending doses of CM001 administered with a portable dry powder inhaler. Studies have begun in healthy volunteers, and the company intends to begin treating people with CF in the second half of this year. The trial is being conducted in New Zealand and is supported by DevPro Biopharma LLC.
Martin Burke, MD, PhD, cystetic Medicines co-founder, said, 'The initiation of our Phase 1 trial for CM001 represents an important step forward in our mission to find a treatment for everyone with CF, especially the final 10% of people with CF who cannot benefit from CFTR modulators. Based on encouraging pre-clinical results and initial biomarker studies in the noses of people with CF not on modulators, we are excited about the potential for this molecular prosthetic approach to restore anion channel function in a way that is independent of CFTR.'
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