Sirnaomics Received Green Light from US FDA for a Clinical Phase IIa Study of Its Leading siRNA Drug
Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announces today that an IND application for a Phase IIa clinical study of the company’s leading siRNA therapeutic candidate, STP705 (Cotsiranib®) has received approval from U.S. Food and Drug Administration. The approval of this “A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar” application comes just on the 30th day after the company submission of the IND package.
Sirnaomics lead product candidate, STP705, is an anti-fibrosis siRNA (small interfering RNA) therapeutic taking advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly diminish both fibrotic activity and inflammatory activity allowing for application in many disease states.
“The green light from US FDA for Sirnaomics’ first IND submission represents a major milestone for the company’s mission in discovery and development of novel siRNA therapeutics for unmet clinical needs. Meanwhile, the STP705 first-in-man study can provide further evidence that our unique approaches for siRNA drug design and PNP formulation may hold great potential of success for RNAi therapeutics,” said the Founder and CEO of the company, Dr. Patrick Y. Lu. “As a first-in-class siRNA therapeutics, STP705 anti-fibrosis and anti-inflammatory properties may be widely applied for other disease conditions.”
“The treatment of abnormal scarring is very important to our patients and the condition can result in both physical and psychological distress. There is a clear unmet medical need in the current treatment of patients with hypertrophic scar and it is very exciting to see new therapeutics such as STP705 enter into clinical study to address a problem that currently has very few effective treatment options,” stated Dr. John Harmon, MD, Director of Surgical Research and Professor of Surgery at Johns Hopkins University in Baltimore, Maryland.
“We are very excited to enter the clinic with STP705 in our first indication of hypertrophic scar. This IND approval serves as validation for our robust preclinical programs. We expect our rigorous clinical study design will enable us to gain great insights into the impact of STP705 on both fibrosis and inflammation and this information will enable us to greatly expand our platform and product pipeline for future disease indications,” the company’s Chief Medical Officer, Dr. Michael Molyneaux, MD and MBA, further emphasized.
About the Planned Clinical Study
The study is a Phase IIa randomized, double-blind placebo controlled study to evaluate the safety and efficacy of various doses of STP705 administered as intradermal injection in subjects with hypertrophic scar. Secondary outcome measures will examine both patient and physician reported scar outcomes with the use of validated scar assessment tools.
About Hypertrophic Scar
Hypertrophic scar formation is a major clinical problem in the developing and industrialized worlds. Burn injuries, traumatic injuries, and surgical procedures can give rise to exuberant scarring that result in permanent functional loss and the stigma of disfigurement. Hypertrophic scar’s 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. Pathophysiology of hypertrophic scars entails a prolonged inflammatory and proliferative phase of wound healing after injury. Among various cytokines promoting hypertrophic scar formation TGF-β1 is known as a key regulator of the aberrant fibrogenic response, while COX-2 as a potent proinflammatory and proliferative mediator.
STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA was demonstrated to inhibit the expression of their target mRNAs and combining the two siRNA’s produced a synergistic effect that diminished profibrogenic factors. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with fibrosis including: α-SMA, Col1A1, and Col3A1. Additional data suggests that reductions in TGF-β1 and COX-2 led to proapoptotic effects in fibroblasts. This data also suggests that STP705 has the potential for broad application in many inflammatory and fibrotic driven disease states. The route of administration for STP705 for Scar Reduction will be via intradermal injection. The Company and its partner, Xiangxue Pharmaceutical Co., Ltd., co-owning China right of STP705 for hypertrophic scar treatment, filed an IND to Chinese FDA.