- Key milestone reached in adaptive Phase 1/1b clinical trial that began in April 2019
Indalo Therapeutics, a biopharmaceutical company discovering and developing integrin antagonists for patients suffering from serious fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and nonalcoholic steatohepatitis (NASH), today announced that the first IPF patient has been dosed in a clinical trial of the company’s lead drug candidate IDL-2965.
Indalo is studying IDL-2965 administered orally once daily in an adaptive multi-part Phase 1 clinical trial. Indalo recently completed the first two parts of the protocol: single- and multiple-ascending dose (MAD) studies in normal healthy volunteers (NHVs). The NHV studies, which explored a 120-fold dose range in 80 NHVs, demonstrated steady-state plasma concentrations at multiples of predicted efficacious exposures and a favorable safety profile. Dosing has now begun in the third part of the protocol: a MAD study in IPF patients designed to measure the effect of IDL-2965 on safety, pharmacokinetics, and biomarkers over 28 days.
“The safety, tolerability, and pharmacokinetics of IDL-2965 in NHVs to date are very encouraging, clearly supporting once-daily oral dosing and advancement into the IPF patient MAD part of the trial,” commented Coordinating Investigator Dr. Toby Maher, the British Lung Foundation Chair in Respiratory Research and Professor of Interstitial Lung Disease at the National Heart and Lung Institute at Imperial College, London, UK.
IDL-2965 is an oral, selective antagonist of avb1, avb3, and avb6 that uniquely inhibits multiple fibrogenic processes, including the local activation of TGF-b (a central regulator of pathologic fibrosis) as well as the ability of stiff extracellular matrix to promote fibroblast migration and survival. This approach provides robust antifibrotic activity across a broad range of tissue types in preclinical models without having to rely on null-like suppression of a single target.
“IDL-2965 has potential in multiple fibrotic diseases including those involving the lung, liver, and kidney,” added Chief Medical Officer Dr. Bill Bradford. “IPF is an attractive first indication for IDL-2965 given the high unmet medical need as well as the demonstrated responsiveness of target-engagement and disease biomarkers to pharmacologic intervention.”
Indalo plans to present data from the NHV studies at the Pulmonary Fibrosis Foundation (PFF) Summit in November.
About Indalo Therapeutics
Indalo Therapeutics is a biopharmaceutical company discovering and developing integrin antagonists for patients suffering from serious fibrotic diseases such as NASH and IPF. Indalo’s approach is unique compared to other therapeutic options being explored as it directly targets multiple processes involved in pathologic fibrosis. Indalo’s founders have investigated integrin antagonist biology and chemistry for decades, and its R&D leadership team was responsible for the development and approval of Esbriet® at InterMune. Atlas Venture and F-Prime Capital co-led the company’s Series A financing in 2017. The company has also received funding from BioGenerator, MTC, iSelect Fund, and other investors. Indalo’s corporate office is located in Cambridge, MA. For more information, please visit www.indalotherapeutics.com.