IM156 on Fast Track as IPF Treatment

The U.S. Food and Drug Administration (FDA) granted fast track status to IM156, ImmunoMet Therapeutics’ treatment candidate for idiopathic pulmonary fibrosis (IPF).

“Fast track designation is another important milestone for ImmunoMet with the potential to speed our ability to advance IM156 to patients,” Benjamin Cowen PhD, ImmunoMet’s CEO, said in a press release.

Fast-tracked compounds may move faster through development and review phases. The designation is given to potential medications developed to treat serious conditions and fill an unmet medical need. It also comes with certain benefits for therapy manufacturers, including the possibility of engaging more frequently with the FDA throughout the development process.

IM156 is an oral treatment meant to reduce fibrosis, or tissue scarring, by blocking the action of protein complex 1 (PC1), a molecule involved in metabolic processes capable of promoting both fibrosis and tumor growth. ImmunoMet is assessing the therapeutic potential of IM156 for the treatment of IPF and certain types of cancer.

So far, the therapy displayed a strong anti-fibrotic effect in preclinical studies conducted in animal models of fibrosis.

“Additionally,” Cowen said, “we are pleased with the progress we are making in the ongoing U.S. Phase 1 study in healthy volunteers.”

Earlier this year, the FDA cleared ImmunoMet’s investigational new drug application for IM156, enabling the company to advance the therapy into clinical testing. ImmunoMet now is planning to initiate a single-site Phase 1 study to evaluate the safety and tolerability of IM156 in approximately 32 healthy volunteers.

An earlier, first-in-human Phase 1 clinical trial (NCT03272256) involving 22 adults with advanced solid tumors was conducted in South Korea.

That trial determined that IM156 was generally well-tolerated. Participants experienced some treatment-related adverse side effects, the most common being nausea, diarrhea, and vomiting. Three participants experienced severe nausea, but no other serious adverse side effects related to treatment were reported.

Although the goal of that study was to evaluate the medication’s safety and tolerability, investigators observed some evidence of anti-cancer activity, allowing them to identify a dose for use in subsequent cancer studies.

The FDA also has designated IM156 an orphan drug for the treatment of IPF. This designation makes ImmunoMet eligible for other development incentives, including tax credits, FDA assistance with clinical trial costs, and seven years of market exclusivity in the U.S., should the treatment gain market approval.