PIPELINE

STRADA™

Strada™ is an orally administered therapy with the potential to improve symptoms of depression in patients with Major Depressive Disorder (MDD). Our Horizon Phase 2 clinical trial testing Strada™ vs. Placebo as an adjunctive treatment of major depressive disorder has recently completed enrollment and we expect results in Q4, 2015.

Strada’s™ formulation significantly enhances the bioavailability of the key active molecule, Ademetionine. In healthy humans in a PK Phase 1 clinical trial, Strada™ demonstrated significantly better bioavailability compared against other commercially available products and has not displayed any serious drug-related adverse events.

Pharmacokinetics of Strada™

Strada 1Strada 2

We believe that Strada™ may demonstrate several ideal properties as a product candidate for MDD including efficacy, safety, low side effect burden, once daily dosing and a unique mechanism of action.

We plan to commence a Phase 3 pivotal program targeting patients who have had an inadequate response to current anti-depressant therapy for the treatment of MDD in the fourth quarter of 2016. Following the Phase 3 program, we plan to seek regulatory approval and commercialize Strada™ in the United States, European Union and Japan. Additionally, we intend to evaluate Strada™ as a potential Monotherapy treatment for MDD.