Enceladus Pharmaceuticals BV announces positive results from a phase 2a study in patients with active ulcerative colitis with Nanocort(R)

-       Results to be presented on March 17^th at ECCO 2016 in Amsterdam

-       Nanocort® is a novel i.v. targeted pegylated liposomal prednisolone product

-       Clear benefit shown in 70% of the patients with 2 administrations

-       7 out of 13 patients showed a reduction of the endoscopy subscore of ≥ 1 point reaching ≤ 1 point

-       Rapid effects on partial Mayo Score with persisting remissions in 7/13 patients treated with Nanocort®

NAARDEN, The Netherlands, March 16, 2016 -- Enceladus Pharmaceuticals today announced results from a randomized, placebo-controlled, observer-blind phase 2a study performed at 2 sites in Belgium and The Netherlands in which the safety and efficacy of Nanocort® PEG-liposomal prednisolone phosphate were evaluated in 18 patients with moderate to severe active ulcerative colitis. At week 4 after initiation of the treatment (2 i.v. administrations) the Nanocort® group showed strong benefit in 70% of the patients with 4 patients out of 13 in remission. 7 out of 13 patients showed a reduction of the endoscopy subscore of ≥ 1 point and reaching ≤ 1 point. Rapid effects on partial Mayo Score were shown with persisting remissions in 7/13 patients treated with Nanocort. Typical steroid-related adverse effects were sparse.

The study results will be presented at the 11^th Congress of ECCO (the European Crohn's and Colitis Association) held in Amsterdam on March 16-19 by the principal investigator of the study Prof Dr Severine Vermeire who is also President of the governing board of ECCO. Professor Vermeire commented: "The outcome of this study suggests that i.v. Nanocort® can be a safe new therapy with fast and durable therapeutic benefit for patients with active ulcerative colitis without the drawbacks of oral steroid standard-of-care. These results should now be confirmed in a larger study. Indeed we would like to further investigate the potential benefit of this new product in our patients, many of whom still struggle to have their disease under control."

"These new positive clinical data show the power of the targeted pegylated liposomal corticosteroid product platform we have developed over the last years", said Bart Metselaar, CEO of Enceladus Pharmaceuticals. "The results underline its broad applicability and validate our strategy to develop Nanocort® in various inflammatory diseases where a fast and durable response is required. Enceladus aims to continue development of Nanocort® in this indication with high medical need in collaboration with a larger industrial partner".

About Enceladus Pharmaceuticals: Enceladus is a privately-owned drug development company based in Naarden, the Netherlands. Enceladus develops drugs based on its pegylated liposomoal corticosteroid platform of which Nanocort® (pegylated liposomal prednisolon) is the most advanced product. Enceladus targets chronic, progressive, and debilitating diseases like inflammatory diseases, autoimmune diseases and cancer. Despite considerable progress in the treatment of these diseases, there remains a large need for further improvement.

Enceladus is embedded in an extensive academic network with strong expertise in colloidal drug carriers for the design of novel products. Enceladus primary focus is on the preclinical and early clinical development of its products. The company collaborates with larger pharmaceutical companies for late stage development and marketing.

Contact: Rolf Jan Rutten

[email protected]

tel: +31646767255

www.enceladus.nl