While we continue to strengthen our innovative algorithm platform, two ASD phenotypes have already been identified, Phenotype 1 and Phenotype 2. Each comprises a set of 12 clinical signs and symptoms.
STALICLA’s first therapeutic package, STALICLA Therapeutic Package 1 (STP1), is intended to offer disease modifying effects by improving the core symptoms of ASD patients. STALICLA will continue to pursue STP1 development and expand its pipeline to serve additional subgroups of patients. Our strategy is to repurpose and develop first-in-class compounds up to Phase II clinical trials before deciding on a case-by-case basis to either keep the development in-house, to partner or to out-license.
STP1 comprises two repurposed drugs, a companion diagnostic assay (challenge test) and a biomarker monitoring assay and is poised to show disease modifying effects in ASD Phenotype 1 patients. Preliminary clinical data indicates that Phenotype1 subgroup represent 15% of the total idiopathic ASD patient population.
The Greenwood Genetic Center will be the first Clinical site for randomized control trials for STP1.
STALICLA aims to submit STP1 to the FDA in Q2 2019.