Indalo Therapeutics has launched a Phase 1 clinical trial testing the company’s lead antifibrotic candidate IDL-2965 for patients with fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and nonalcoholic steatohepatitis (NASH), an inflammatory liver disease.
The biopharmaceutical company announced it has now dosed the first healthy volunteer in the initial portion of the trial.
The Phase 1/2a trial will begin by testing the safety and pharmacokinetics (the therapy’s absorption, distribution, metabolism, and excretion) of IDL-2965 in healthy participants, and then will assess fibrosis-associated markers in patients.
Indalo intends to collect data to support the development of the therapy for one or more fibrotic diseases in 2020.
“IDL-2965 reflects true scientific innovation in the biology of treating fibrosis, an area with a significant unmet medical need,” Bill Bradford, PhD, MD, chief medical officer at Indalo, said in a press release. “Despite recent medical advances, median survival for patients diagnosed with IPF is still worse than many cancers, while NASH is rapidly becoming one of the most devastating epidemics of our time.”
The oral, small molecule IDL-2965 is an inhibitor of three integrins — transmembrane receptors that mediate the interactions between cells, or cells and the extracellular matrix — named αvβ1, αvβ3, and αvβ6. By inhibiting these integrins, the therapy can block the activation of the profibrotic signaling-molecule transforming growth factor beta (TGF-β) and the stiffening of the extracellular matrix, a process linked to fibrosis.
Earlier preclinical studies using IDL-2965 on animal models showed potent antifibrotic effects at low once-daily doses. The studies assessed the therapy’s efficacy in several vital organs, including the liver, lung, and kidney.
“With the initiation of this study, IDL-2965 becomes one of very few direct antifibrotic drugs in clinical development for NASH and IPF, our initial target indications,” said Robert Jacks, president and CEO at Indalo. “We are now laser-focused on advancing IDL-2965 rapidly into clinical evaluation in multiple patient populations to demonstrate the potential of our unique approach to treating fibrosis.”
Scott Seiwert, PhD, chief scientific officer of Indalo, is presenting the findings associated with IDL-2965 at the 3rd Annual NASH Summit on April 24 in Boston.
The Cambridge-based company has a particular interest in discovering and developing integrin inhibitors for patients with fibrotic diseases. The company has received funding from BioGenerator and iSelect Fund, among other investors.