Blog

Indalo Therapeutics Presents Phase 1 Clinical Trial Results for Lead Antifibrotic Drug Candidate IDL-2965

  • Demonstrates strong safety and oral PK
  • Data presented November 7, 2019 at PFF Summit, San Antonio, TX

Cambridge, MA, November 11, 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), for the first time presented clinical data for the company’s lead antifibrotic drug candidate IDL-2965 at the Pulmonary Fibrosis Foundation (PFF) Summit on November 7. The data demonstrate excellent safety and tolerability at concentrations that are multiples of those anticipated to be necessary for efficacy, as well as strong oral pharmacokinetics supportive of once-daily oral dosing.

Indalo is studying IDL-2965 administered orally once daily in an adaptive multi-part Phase 1 clinical trial. The data presented at the PFF Summit relate to the recently completed first two parts of the protocol: single- and multiple-ascending dose (SAD and MAD) studies in normal healthy volunteers (NHVs). The SAD study explored a 120-fold dose range from 3 mg to 360 mg, while the MAD study explored doses from 15 mg to 135 mg administered once daily for 14 days. Dosing is ongoing in the third part of the protocol, a 28-day MAD study in IPF patients designed to measure safety, pharmacokinetics, and effects on a robust panel of target-engagement and disease biomarkers.

“Progressive fibrosing interstitial lung diseases (ILD) such as IPF remain a high unmet medical need associated with significant morbidity and mortality,” commented Lead Author 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. “The unique and compelling mechanism of action of IDL-2965 coupled with these favorable data support the ongoing IPF Proof-of-Biology study and additional studies in ILD.”

Click here to read the entire press release.