Private Company Spotlight
Company: STALICLA SA (Geneva, Switzerland)
Therapeutic focus: Autism spectrum disorder (ASD)
STALICLA, which was founded in May 2017 by CEO Lynn Durham, is attempting to identify subgroups of patients with idiopathic ASD by utilizing a big data approach, and then planning to treat them using combinations of “repurposed drugs.” The company, which has raised seed funding, believes that significant clinical and preclinical evidence has accumulated over the past decade or so that leads it to believe that alterations in molecular pathways lead to abnormal cell functioning that could be features of ASD. To this end it is utilizing a proprietary algorithm called DEPI (database endophenotyping patient identification) to analyze scientific data/literature and identify links between ASD and non-ASD-based data, which it then filters using non-behavioral clinical sets of signs and symptoms of ASD.
At this early stage, STALICLA has identified two phenotypes of ASD; each has a series of 12 clinical signs and symptoms. The company has put together what it is calling STP1 (STALICLA therapeutic package 1), which is a combination of two repurposed small molecules (one that will restore intracellular processes, and another that could sustain the therapeutic effect) that it has not yet identified due to competitive reasons. The package also has a diagnostic assay (STP-1 challenge test) and a biomarker monitoring assay that STALICLA believes is “poised to show disease modifying effects in ASD Phenotype 1 patients.” The company is partnered with the Greenwood Genetic Center (SC), which will become the first clinical trial site for randomized trials of STP1.
STALICLA plans to file STP1 with the FDA in 2Q19. The company will initially target the US market and then the EU, and expects first revenues in 2025, assuming trials are successful and the package is approved. With a starting point of 1 in 110 for prevalence for moderate-to-severe patients, STALICLA’s initial estimate is that Phenotype 1 will involve ~15% of ASD patients or ~1.2mn patients in the US. STALICLA assumes peak sales of $2-3bn/year (year to reach peak not identified). -Sumant Kulkarni