Ichnos (‘īk-nōz) Sciences today announced that it has completed enrollment of two Phase 2b clinical trials for two candidates in clinical development: ISB 830, an OX40 antagonist monoclonal antibody currently in development for the treatment of atopic dermatitis, and ISC 27864, a non-opioid, potent, selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) currently in development for osteoarthritic pain.
In the randomized, double-blind, placebo-controlled study of ISB 830, three different doses/regimens of the monoclonal antibody are being evaluated in adult patients with moderate to severe atopic dermatitis. A total of 312 participants were randomized at sites in the US, Canada and Europe. The primary endpoint being evaluated is the proportion of subjects with both Investigator’s Global Assessment (IGA) of 0 to 1 (on a 5-point scale) and an IGA reduction from baseline of ≥2 points at the end of 16 weeks of treatment. Additional efficacy endpoints, as well as safety and tolerability are being assessed. Topline results are expected in the 1st half of 2020 and will be submitted for presentation at scientific meetings.
In the randomized, double-blind, placebo-controlled study of ISC 27864, three doses of the oral mPGES-1 antagonist administered once-daily are being evaluated in adult patients with moderate osteoarthritic pain of the knee and/or hip. A total of 624 subjects were randomized at sites in India. The primary endpoint being evaluated is the mean change from baseline in the Western Ontario and McMaster’s University Osteoarthritis Index pain subscale (WOMAC-PS) at the end of 12 weeks of treatment. Additional efficacy endpoints as well as safety and tolerability are being assessed. Data are also being collected for biomarkers that may demonstrate differentiation of ISC 27864 action from that of non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (COX-2s). Topline results are expected in the 1st half of 2020 and will be submitted for presentation at scientific meetings.
“Enrollment is now complete for both Phase 2b, dose-ranging studies with ISB 830 and ISC 27864, and this marks an important step in bringing forth potential treatments for unmet medical needs,” said Alessandro Riva, MD, Chief Executive Officer of Ichnos Sciences. “We are pleased to reach these clinical development milestones so quickly after our company’s launch and remain committed to rapidly advancing our pipeline toward new treatment options for diseases with unmet needs.”
About ISB 830
ISB 830 is an anti-OX40 monoclonal antibody and Ichnos Sciences’ lead biologic candidate. By blocking OX40 on the surface of activated T cells, ISB 830 down-regulates overactive T cells, reducing symptoms of autoimmune disease. Based on an entirely new mechanism of action, ISB 830 has the potential to treat a range of diseases beyond atopic dermatitis. ISB 830 was renamed from GBR 830 following a corporate reorganization.
About ISC 27864
ISC 27864 is a non-opioid, potent, selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) which is a novel therapeutic target for pain in inflammatory conditions. Ichnos Sciences is developing analgesic drugs with novel mechanisms of action to provide an alternative to opioids and other commonly used treatments that may have limitations in efficacy or tolerability. ISC 27864 was renamed from GRC 27864 following a corporate reorganization.
A fully integrated, global biotech with the spirit of a start-up, Ichnos Sciences is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology, autoimmune disease and pain. The Company, with headquarters in Paramus, N.J., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and treat patients holistically. With a patented BEAT® technology platform, along with pioneering teams in Switzerland and India, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will hopefully extend and improve lives, writing a new chapter in healthcare. For more information, visit IchnosSciences.com.