ReCode Therapeutics said that it has initiated a Phase 1 clinical trial of its RCT1100 nebulized mRNA-based therapeutic, which the company is developing for the treatment of primary ciliary dyskinesia (PCD) caused by certain genetic mutations. ReCode had announced positive preclinical results for RCT1100 for the treatment of PCD in August 2021.
The Phase 1 single ascending dose study is expected to enroll 32 healthy subjects who will receive either RCT1100 or placebo delivered via the PARI eFlow nebulizer system. ReCode says that it expects to submit INDs for a second Phase 1 trial of RCT1100 in PCD patients and for a trial of its inhaled CFTR mRNA therapeutic for the treatment of cystic fibrosis by the end of this year.
ReCode CEO Shehnaaz Suliman commented, “Initiating this clinical study of RCT1100, which was developed using our novel selective organ targeting (SORT) lipid nanoparticle (LNP) delivery platform, represents a major milestone for ReCode and delivering on the promise of extra-hepatic delivery of genetic medicines. Our platform enables precise delivery of genetic medicines like RCT1100 to cells impacted by disease, and we are one step closer to initiating a clinical trial in PCD patients.”
Read the ReCode Therapeutics press release.
