" class="no-js "lang="en-US"> Istesso Announces FDA Fast Track and Orphan Drug Designation for MBS2320 - Pharmtech Focus
Friday, January 27, 2023

Istesso Announces FDA Fast Track and Orphan Drug Designation for MBS2320

Istesso Limited, the immunometabolism drug discovery and development company, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for Istesso’s investigational metabolic reprogramming agent, MBS2320, for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

The fast track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A fast track drug must show some advantages over available therapy, such as the potential for superior effectiveness or an improved effect on serious outcomes.

MBS2320 is a first-in-class investigational drug which is currently in clinical development for the treatment of rheumatoid arthritis (RA) where it has demonstrated a unique profile, reducing inflammation and supporting the remodelling of damaged bone. In models of IPF, MBS2320 has shown a similarly unique profile, reducing symptoms of IPF while also supporting remodelling of fibrotic tissue. A clinical study in patients with IPF will start in 2023.

The FDA has also designated MBS2320 an orphan drug for the treatment of IPF. This designation makes Istesso eligible for 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.

Dr Lisa Patel, CEO and co-founder of Istesso comments: “This fast track designation reflects the pressing need for new treatments to help patients with IPF. At Istesso we are committed to creating genuine improvements in patients’ health and quality of life. 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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