Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2 study of the company's drug candidate, STP705, for Keloid scar prevention. STP705 is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression.
No treatment options, apart from surgical removal, are currently available for patients with keloid scarring, which is a serious medical condition of abnormal scar formation and pain that can cause negative psychological impacts on patients who suffer from the disease," said Michael Molyneaux M.D., Chief Medical Officer at Sirnaomics. "Dosing our first patient in the Phase 2 study is critical to moving the STP705 program forward, and learning more about the impact on patients who are suffering from this condition."
The Phase 2 trial is a multi-center, randomized, double-blind, multiple-arm, controlled study and is designed to evaluate the safety and efficacy of various doses of STP705 in reducing post-keloidectomy keloid recurrence in adult patients. Sirnaomics plans to enroll a total of 50 patients in the Phase 2 study. The primary endpoint of this trial is to measure the rate of recurrence in patients who have undergone surgery alone (receiving placebo) versus surgery and STP705 at three months, six months, and 12 months post-surgical excision.
"With this milestone in our research, the first patient dose of STP705 will allow us to receive additional data on safety and tolerance," said Patrick Lu, Ph.D., founder, President and Chief Executive Officer at Sirnaomics. "We look forward to seeing the results readout of this clinical trial surrounding STP705's unique mechanism of action on skin fibrotic scarring."
Sirnaomics expects to report initial clinical data from the Phase 2 trial in the second half of 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04844840.
About Keloid Scar
Keloids form as a result of aberrations of physiologic wound healing and may arise following any insult to the deep dermis. By causing pain, pruritus and contractures, excessive scarring significantly affects the patient's quality of life, both physically and psychologically. Decades of multiple studies on keloid formation have led to a plethora of therapeutic strategies to prevent or attenuate excessive scar formation. However, most therapeutic approaches remain clinically unsatisfactory, most likely owing to poor understanding of the complex mechanisms underlying the processes of scarring and wound contraction.
