To address the unmet medical needs in fibrosis, the Indalo team has synthesized and characterized a broad portfolio of proprietary, drug-like, small-molecule RGD-binding integrin antagonists with varying specificity profiles. Our strategy is to target key RGD-binding integrins on fibroblasts and epithelial cells to inhibit multiple processes of pathologic fibrosis. Indalo’s novel chemistry is unique compared to other therapeutic options being explored, as it provides the targeted specificity profile in oral small molecules with favorable drug metabolism and pharmacokinetic (DMPK) properties. Compounds in our portfolio have demonstrated strong activity in preclinical models of hepatic, pulmonary, renal, pancreatic, cardiac, muscular, and surgical implant fibrosis.
Indalo’s lead drug candidate, IDL-2965, is an oral, selective, RGD-binding integrin antagonist that inhibits multiple processes of pathologic fibrosis, including the activation of TGF-β (a fibrogenic growth factor) and the ability of stiff extracellular matrix to promote fibroblast migration and survival. IDL-2965 displays potent antifibrotic activity in multiple disease models at low once-daily doses. Indalo has completed a rigorous set of GLP toxicology and safety-pharmacology studies with IDL-2965 in preparation for human trials, resulting in a favorable safety profile with a large projected therapeutic index.
Indalo has designed an efficient and adaptive Phase 1 clinical program, in which we plan to thoroughly characterize safety and pharmacokinetics in both healthy subjects and patients with NASH and IPF. We will also explore markers of target activation and disease progression. The first Phase 1 clinical trial is scheduled to initiate in early 2019.