Drug Product
Namodenoson is an oral small molecule drug generically known as Cl-IB-MECA (2-chloro-N6-(3-iodobenzyl)-adenosine-5’- N-methyl-uronamide), a highly specific and selective agonist at the A3 adenosine receptor (A3AR):

Preclinical Pharmacology
Namodenoson has potent anti-cancer effect, particularly against hepatocellular carcinoma, and anti-inflammatory activity demonstrated in pre-clinical animal models of liver inflammation.

Mechanism of Action
Namodenoson mechanism of action is mediated via de-regulation of the NF-κB and the Wnt signal transduction pathways, resulting in apoptosis of tumor cells. The protective effect of Namodenoson is mediated via down-regulation of the NF-kB signal transduction pathway and preventing apoptosis.

Safety
The safety of Namodenoson has been demonstrated in preclinical studies, Phase I clinical study and in human Phase II clinical studies demonstrating a favorable safety profile.

Efficacy
1. Hepatocellular Carcinoma
 Phase I/II study in hepatocellular carcinoma (HCC) successfully met its primary and secondary endpoints demonstrating initial indications for efficacy of Namodenoson. A global Phase II study treating patients with Namodenoson as a second line therapy has recently been concluded. Although the overall survival primary endpoint failed,  a robust clinical effect has been demonstrated in a sub population of Child Pugh B7 (CPB7) patients. In an End of Phase II meeting with the FDA, the company reached an agreement with the agency on a Phase III protocol in the CPB7 population.
2. NASH (Nonalcoholic steatohepatitis)
A Phase II study in patients with NAFLD/NASH has recently completed patients’ enrolment and data are expected Q1/2020.