Biopharmaceutical company Sirnaomics has initiated the Phase IIa trial of its small interfering RNA (siRNA) therapeutic candidate STP705 (Cotsiranib) to treat patients with hypertrophic scar.
STP705 is an anti-fibrosis siRNA therapeutic designed to reduce fibrotic and inflammatory activity with dual-targeted inhibition and polypeptide nanoparticle (PNP)-enhanced delivery.
The drug is made of two siRNA oligonucleotides, which target TGF-β1 and COX-2 mRNAs, as well as contain nanoparticles with Histidine-Lysine Co-Polymer (HKP) peptide.
The randomised, double-blind, placebo controlled Phase IIa trial will evaluate the safety and efficacy of different doses of intradermal STP705 injection in patients with hypertrophic scar.
Sirnaomics founder and chief executive officer Patrick Lu said: "This first-in-man study of STP705 in the US will provide safety and efficacy evidence of Sirnaomics' unique siRNA drug design and the PNP formulation for a novel antifibrotic therapeutic approach.
"The knowledge and experience from the intradermal injection of this siRNA therapeutic should pave a path towards utilising this drug candidate systemically for other fibrotic disease treatments, addressing broader unmet clinical needs."
The hypertrophic scar is formed during burn and traumatic injuries and surgical procedures, and also causes pain, pruritus and contractures. It features TGF-β1 as a regulator of the aberrant fibrogenic response and COX-2 as a potent proinflammatory and proliferative mediator.
The study will initially assess the safety, tolerability, and efficacy of the drug for treatment of skin hypertrophic scars caused due to abnormal healing after surgical procedures.
The trial will further utilise validated scar assessment tools to measure the patient and physician reported scar outcomes.