Oncodesign Precision Medicine (OPM announced the clinical entry of its drug candidate ODS-101 with the first subject dosing in Phase 1 clinical trial in healthy volunteers. Inflammatory Bowel Disease (IBD) includes conditions such as ulcerative colitis (UC) and Crohn's disease (CD). The number of patients concerned has been estimated at 10 million worldwide with a prevalence of 1% (EFCCA analysis), which is constantly increasing, mainly in developed countries.

The combined global 8MM (8 major markets) UC and CD market accounted for $14.2 billion in 2019 with growth forecast to 2029 at $24.9 billion (GlobalData 2020 Reports). RIPK2 plays a key role in modulating the innate immune response, making this kinase particularly relevant to address the need for safer and more effective therapies for patients who often experience significant side effects with current therapies. Furthermore, the current knowledge about this target, associated with the favorable profile of ODS-101, opens up the possibility to realize combinations with first-line treatment therapies, particularly those based on anti-TNFa antibodies.

ODS-101 is a macrocyclic molecule from OPM's proprietary Nanocyclix® platform. It is a highly potent Type 1 inhibitor (inhibitor in the active cavity of the kinase), selective against other kinases and orally bioavailable. In pharmacology studies, ODS-101 has demonstrated good efficacy in several preclinical models of colitis.

Its safety profile in preclinical studies meets a quality standard recognized by the pharmaceutical industry and compatible with chronic administration to treat diseases such as IBD. OPM's intellectual property strategy is effective in protecting the value of this asset and its use in a wide range of therapeutic indications. The announced "First-in-human" clinical study is a randomised, double-blind, placebo-controlled, healthy volunteer study with a single administration phase (SAD – single ascending dose) and a multiple administration phase (MAD - multiple ascending dose) design to study the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ODS-101.

This Phase 1 also includes the study of the food effect and the study of the gender effect in order to prepare as well as possible the future clinical development of the molecule. About the Nanocyclix® technology The Nanocyclix® technology is based on small macrocyclic molecules designed to inhibit the human kinome (the family of kinases that has more than 500 members), which plays a role in more than 400 diseases. These molecules represent an extraordinary opportunity thanks to their physicochemical properties (low molecular weight, cell membrane crossing, selectivity) to target with high potency and selectivity little explored or notoriously difficult kinases and to obtain drug candidates that meet the specifications compatible with ambition to deliver therapeutic agents in precision medicine.