- Key milestone reached in adaptive Phase 1/1b clinical trial that began in April 2019
Cambridge, MA, October 21, 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.
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