Sublimity Therapeutics to Present Positive Data for Ulcerative Colitis Drug Candidate

2019 European Crohn’s and Colitis Congress Presentation Highlights ST-0529 Advantages

Solana Beach, Calif., March 8, 2019 – Sublimity Therapeutics, a specialty pharmaceutical company focused on the treatment of ulcerative colitis, today announced the presentation of data showing that the company’s lead drug candidate, ST-0529, given once daily, was safe, well tolderated and showed a numerically higher difference in remission rates in patients with mild-to-moderate ulcerative colitis compared to placebo after only four weeks of treatment.

The oral presentation is entitled “A Randomised, Multi-Centre, Double-Blind, Placebo-Controlled Study of a Targeted Release Oral Cyclosporine Formulation in the Treatment of Mild-to-Moderate Ulcerative Colitis: Efficacy Results,” at the 2019 European Crohn’s and Colitis Organisation Congress in Copenhagen.

Notably, in the post hoc analysis, differences in the clinical response between treatment subgroups achieved statistical significance in some subgroups. The largest clinical response rate was found in moderate ulcerative colitis patients taking 5-aminosalicylates and/or steroids.

ST-0529 (formerly “CyCol®”) is a cyclosporine-based therapy administered via Sublimity’s proprietary, advanced oral drug delivery technology platform, the Single-Multiple Pill (SmPill®). 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.

Oral Presentation Details
Session name: Scientific Session 5: IBD Around the World
Date and time: Friday, March 8, 11:50 a.m. – 12:00 p.m. CET
Presenting author: Dr Stuart Bloom, University College Hospital

The presentation is being made available on the Sublimity Theapeutics website at beginning on Friday, March 8.

About Ulcerative Colitis

It is estimated that ulcerative colitis affects approximately 1.7 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, a specialty pharma company with offices in Dublin, Ireland, and San Diego, California, is a clinical-stage biotechnology company dedicated to identifying and creating meaningful new therapies for unmet clinical needs in gastrointestinal and immunological diseases. Led by a team of industry innovators and leveraging our Single-Multiple Pill (SmPill®) technology, we are advancing a diverse pipeline of oral small molecules and peptides that have the potential to make important contributions to human health.

SmPill® Technology

Sublimity’s proprietary SmPill® technology is a versatile delivery system for solubilizing active therapeutic agents that are otherwise poorly soluble due to their molecular properties. This process involves hydrophobic and hydrophilic phases to reconstitute the active pharmaceutical ingredients (APIs) as polymer-coated minispheres that control the drug release profile and protect the API from degradation. This technology has broad applications for drugs with poor solubility, poor gastrointestinal permeability, a propensity for degradation in the stomach and by heat, or drugs with suboptimal pharmacokinetics. It also provides an avenue to deliver API directly to the gut with a targeted, local approach.

In addition to the CYC-202 study, Sublimity is moving forward with two new treatment programs for gastrointestinal disease.

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