Our cutting-edge R&D approach is to selectively target novel MOAs amongst the complex cytokine/chemokine network and signal transduction pathways that have already been target-validated with an established preclinical Proof of Concept in disease-specific animal models of the therapeutic indications of interest. Our de novo Drug Discovery efforts in our state-of-the-art research center apply Fragment-based Drug Design [FBDD] coupled with Structure-based Drug Design [SBDD] that enables the discovery of high-quality drug lead compounds. Using this paradigm enables the discovery of bespoke selective drug-like small molecules that are 'rule-of-five' compliant with highly favorable physico-chemical and ADMET properties. Our NME compound candidates are being designed to be highly efficacious and potent, to demonstrate a superior safety profile by minimizing off-target and on-target toxicities, and to have a wider therapeutic index; properties that will provide significant advances over limited available treatments.

Our robust Preclinical and Clinical Development strategy is based on an optimal Target Product Profile implemented for each targeted disease indication. Our approach is to apply stringent Go/No-Go criteria, above and beyond the required ICH M3(R2) guidelines of the U.S. Food and Drug Administration, as we reach our milestone IND filings and clinical Proof of Concept. Due to the novelty of our compound candidates’ MOAs, biomarker development will also be implemented as early as in the Preclinical IND-enabling phase and throughout Phase I/II Clinical development to enable complementary Companion Diagnostics to be developed in parallel to the advancing compound candidate.