Sublimity Therapeutics Receives Investigational New Drug (IND) Clearance from U.S. Food and Drug Administration (FDA)

Company also Receives Ireland Authorization and Health Canada Clearance

Phase 2b Clinical Trial of ST-0529 for the Treatment of Ulcerative Colitis to Launch This Month

SAN DIEGO, Jan. 07, 2019 (GLOBE NEWSWIRE) — Sublimity Therapeutics, a specialty pharmaceutical company focused on the treatment of ulcerative colitis, announced today 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, Ph.D. “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 U.S.,” said Sublimity Chief Medical Officer, Jesse Hall, M.D. “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.

About Ulcerative Colitis

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.

About Sublimity Therapeutics

Sublimity Therapeutics is a specialty pharma company with offices in Dublin, Ireland, and Solana Beach, California. 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 US$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, please visit our website at

About Dr. Falk Pharma GmbH

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.

Forward-Looking Statements

This press release contains forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning or by using future dates in connection with any discussion thereof.  In particular, statements, express or implied, concerning future actions, conditions or events, future operating results, including, but not limited to, the potential medical benefits of ST-0529, the perceived potential opportunity in the ulcerative colitis market for an oral alternative, the intended launch of the Phase 2b clinical trial and the success of such clinical trial and the launch and success of any future clinical trials, the ability to obtain required regulatory approval for ST-0529, and risks related Sublimity meeting some or all of the milestones required to be met for future funding by investors, are forward-looking statements. We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions.  Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. You should bear this in mind as you consider forward-looking statements, and you are cautioned not to put undue reliance on forward-looking statements. Sublimity undertakes no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


Company Contact:
Albert Agro
President & CEO
Sublimity Therapeutics

David Schull
Russo Partners LLC
(212) 845-4271