AMCase

WARSAW, June 23, 2022 /PRNewswire/ -- Molecure S.A. ("Molecure": WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal capabilities to discover and develop first in class small molecule drug candidates that directly modulate RNA and unexplored protein targets to treat multiple incurable diseases, announces today that it has regained full rights to its dual chitinase inhibitor OATD-01 together with all the related IP and know-how, full drug substance and drug product inventory. This is the result of an ongoing corporate strategy and portfolio review by its partner Galapagos NV. Marcin Szumowski, Molecure CEO commented "We have enjoyed a very productive relationship with Galapagos and are pleased that we have been able to regain rights to OATD-01, which we believe holds great promise in several respiratory indications. Data generated to date reveal an attractive benefit-risk profile for this asset, and we look forward to revising our clinical strategy for the further development and subsequent partnering of this program in the near future." Andre Hoekema, Ph.D., Chief Business Officer of Galapagos added "We are grateful to have had the opportunity to partner with Molecure and to work on OATD-01. However, as part of an ongoing strategic exercise to renew and accelerate our portfolio, we decided to return all rights to OATD-01 to Molecure, with the confidence that they will progress this promising asset through the next stages of development." The return of OATD-01 and associated chitinase inhibitor programs provides Molecure with a renewed opportunity to generate value for its shareholders. Once the internal assessment of data, reports and information received from Galapagos is completed, Molecure considers to initially develop OATD-01 in sarcoidosis, its preferred and originally selected indication. The company will seek the optimum path forward in this indication, with the intention to conduct a Phase II proof-of-concept (PoC) study. This will likely be an international study recruiting patients in the United States and Europe, including Poland. Molecure has regained (at no cost) the full and exclusive rights to the results of all research, pre-clinical and clinical development performed by Galapagos with OATD-01 over the course of the last 18 months. The non-refundable Eur27 million received by Molecure in November 2020 as part of the original licensing deal and right of first negotiation of other molecules from its chitinase platform could support this important Phase II clinical study. Molecure believes that the studies performed by Galapagos together with the scientific advice received from the EMA are highly supportive of further progressing OATD-01 into phase II clinical trials in the near term. Molecure is confident that a positive result from the planned Phase II PoC study in sarcoidosis patients would open the possibility for the company to partner OATD-01 and its chitinase inhibitor IP for the second time. Molecure is committed to solving unmet medical needs of patients with interstitial lung diseases, inflammation driven fibrosis and cancer. The Company looks forward to further informing investors on the next steps in the planned clinical development for OATD-01 in the coming weeks. Dr Samson Fung, Molecure CMO, commented "Sarcoidosis is a systemic disease of unknown cause that is characterized by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system. Sarcoidosis is a global disease, affecting both men and women with a prevalence of about 5–50 in 100 000, with 70% of the patients aged between 25 and 45 years. The most severe and frequent complication of sarcoidosis is the occurrence of pulmonary fibrosis. This is usually associated with significant impairment of pulmonary function. Pulmonary fibrosis results in the majority of deaths related to sarcoidosis in western countries. There is currently no cure for sarcoidosis and treatments only modify the granulomatous process and its clinical consequences. During preclinical development, OATD-01 has been shown to significantly decrease the disease burden in the lungs of treated animals. In patients, the over-expression of CHIT1, the target of OATD-01 is both a marker of severity and disease progression."