Sirnaomics Doses First Patient in Phase Ⅱ Study of STP705 for Keloid Scar Prevention
Expects to Report Initial Clinical Data in Second Half of 2021
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.
Pathophysiology of keloids entails a prolonged inflammatory and proliferative phase of wound healing after injury. Among various cytokines promoting keloids formation, TGF-β1 is known as a key regulator of the aberrant fibrogenic response, while COX-2 acts a potent proinflammatory and proliferative mediator. When STP705 was locally injected into the human hypertrophic scar tissues, which were surgically removed from patients and implanted onto nude mice, the company observed scar size reductions, accompanying with not only target gene silencing but down regulation of fibrogenic markers including α-SMA, hydroxyproline, Collagen 1, and Collagen 3. Further analysis revealed that STP705 is able to induce fibroblast apoptosis both in vitro and in vivo. Therefore, the synergistic effect of simultaneous silencing of TGF-β1 and COX-2 may reverse skin fibrotic scarring through minimizing inflammation and activating fibroblast apoptosis. This mechanism of action of STP705 can be widely applied for treatment of many fibrotic conditions.
Sirnaomics’ product candidate, 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. The product candidate has received multiple IND approvals from both the U.S. FDA and Chinese NMPA, including treatments of cholangiocarcinoma, nonmelanoma skin cancer, and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma and primary sclerosing cholangitis. A Phase 2a study of STP705 for treatment of squamous cell skin cancer (isSCC) in adult patients demonstrated positive efficacy and safety results, with 76% of all patients (19/25) achieving complete histologically clearance and the two optimal dosing ranges achieving 90% histological clearance of tumor cell in the lesion. No significant or serious adverse events, including no significant cutaneous skin reactions, were reported in the study, and the company was able to define a clear therapeutic window in advance of later stage studies.
Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The Company’s mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors and corporate partnerships. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at www.sirnaomics.com.