Sublimity Therapeutics Receives IND Clearance

Sublimity Therapeutics recently announced that the company has received FDA clearance to proceed with its Phase 2b clinical trial of the company’s lead drug candidate, ST-0529. The aim of this multicenter, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the safety, efficacy, and tolerability of ST-0529 for patients with moderate to severe ulcerative colitis.

“The acceptance of this IND by the FDA is a significant milestone for ST-0529 and patients suffering from ulcerative colitis whose current treatment options fall short,” said Sublimity Chief Executive Officer, Albert Agro, PhD. “ST-0529 has the potential to be a safe and cost effective alternative to currently available biologic drugs and to curb the need for steroids and systemic immunosuppressants in ulcerative colitis treatment.”

Sublimity also announced that in response to its clinical trial application, the company has received a No Objection Letter from Health Canada, providing clearance to proceed with the trial in Canada. Ireland’s Health Products Regulatory Authority has also granted authorization for the trial.

“Sublimity is advancing its clinical development program and will immediately initiate screening and enrollment of approximately 280 patients in 18 countries across Europe, Israel, Canada, and the US,” said Sublimity Chief Medical Officer, Jesse Hall, MD. “We anticipate launching the trial with the dosing of the first patient later this month.”

ST-0529 (formerly CyCol) is a cyclosporine-based therapy administered via Sublimity’s proprietary, advanced oral drug delivery technology platform. As systemic risks have limited the use of conventional injected and oral cyclosporine, ST-0529 allows for optimized local, topical treatment of gastrointestinal diseases while minimizing systemic absorption. A prior Phase 2a study in more than 100 patients with mild to moderate ulcerative colitis demonstrated that ST-0529 was safe and well tolerated.

Guided by the data generated in and results from Sublimity’s Phase 1 and 2a studies, a range of twice-daily ST-0529 doses will be compared with placebo in patients presenting with moderate to severely active ulcerative colitis who are failing to demonstrate an adequate response to one or more of 5-ASA, steroid or immunosuppressive therapies at screening. Patients with a previous history of having failed a single biologic will be eligible for enrollment. The data generated from this study is intended to support the design and launch of a Phase 3 clinical trial.

 It is estimated that ulcerative colitis affects approximately 1.4 million patients in North America, Europe, and other developed countries. The moderate-to-severe patient segment represents the fastest growing market segment, with double-digit annual growth. The mainstays of treatment for this disease are anti-TNFs; however, these drugs are limited by their toxicities and safety liabilities.  A large portion of patients are either unresponsive to initial front-line anti-TNF therapy or become refractory to treatment within the first year. Despite the introduction of new medicines, these patients still have significant unmet medical needs.

 Sublimity Therapeutics is a specialty pharma company with offices in Dublin, Ireland, and Solana Beach, CA. Sublimity’s goal is to identify and create meaningful new therapies for unmet clinical needs in gastrointestinal and immunological diseases. Sublimity’s priority focus is on its lead product, ST-0529, for treatment of moderate-to- severe ulcerative colitis. Sublimity has a strategic collaboration with Dr. Falk Pharma GmBH that includes development funding, milestone payments and tiered double-digit royalties for the future development and commercialization of ST-0529 and related products in Europe. In May 2018, Sublimity announced a financing of up to $64 million, subject to the achievement of certain milestones, to further the development of ST-0529, including a global Phase 2b dose-ranging study designed to evaluate the safety and efficacy of ST-0529. The financing was co-led by OrbiMed and Longitude Capital with participation from HBM Healthcare Investments. For more information, visit at www.sublimitytherapeutics.com.

Dr. Falk Pharma GmbH is one of the leading companies worldwide in gastroenterology with its products being sold in more than 60 countries. Its pharmaceuticals are used successfully to treat inflammatory bowel disease, cholestatic liver disease, irritable bowel syndrome, constipation, and for colon cleansing prior to colonoscopies. The Falk Foundation, which is associated with the company, provides medical information via international symposia, forums, postgraduate courses, and literature services. Over the past 45 years the Falk Foundation has sponsored more than 200 international Falk symposia and workshops in which over 100,000 researchers and physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology.