Istesso Limited announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to MBS2320, an investigational metabolic reprogramming agent designed for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

The announcement, made via news release, noted that MBS2320 has been shown to reduce symptoms of IPF while supporting fibrotic tissue remodeling.

“This fast track designation reflects the pressing need for new treatments to help patients with IPF,” Dr. Lisa Patel, chief executive officer and cofounder of Istesso, said. “This fast-track designation is an important milestone that will help us advance MBS2320 to patients with this debilitating and life-threatening condition more rapidly.”


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IPF is a progressive lung disease characterized by the buildup of fibrotic tissue in the lungs. Common symptoms of IPF include dyspnea, chronic cough, “velcro” crackles on lung auscultation, sicca, and arthralgia. Its exact cause is unknown, but environmental, genetic, and epigenetic factors are suspected.

Read more about IPF experimental therapies

Only 2 drugs, pirfenidone and nintedanib, have been approved by the FDA to treat IPF. Both are antifibrotic agents that slow the decline in lung function in patients, but no treatment has been found to stop or reverse the disease process.

Investigational therapies such as MBS2320 that have been granted fast track status must demonstrate advantages over other existing treatments, such as superior effectiveness or better patient outcomes. The designation helps facilitate and expedite drug development and review, particularly for serious diseases for which there are few effective therapies.

MBS2320 is already in clinical development for patients with rheumatoid arthritis, for which it has been shown to reduce inflammation and support bone remodeling. It acts by selectively modulating immune metabolism. A clinical study on MBS2320 for patients with IPF is expected to launch in 2023.

Reference

Istesso Ltd – announces FDA Fast Track and Orphan Drug designation for MBS2320. News release. Istesso Limited; December 5, 2022.