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FDA grants fast-track designation for Istesso’s IPF candidate

The therapy has reduced inflammation and supported the remodelling of damaged bone.

Istesso – a London-based immunometabolism drug development company – has announced that the US Food and Drug Administration (FDA) has granted its ‘fast-track’ designation for Istesso’s investigational metabolic reprogramming agent, MBS2320

The therapy involves the treatment of patients with idiopathic pulmonary fibrosis (IPF).

The process is designed to facilitate the review of drugs to treat serious conditions and fill an unmet medical need. Meanwhile, the purpose is to get vital new drugs to the patient earlier. A fast-track treatment must show some advantages over existing therapies, such as the potential for superior effectiveness or an improved impact on serious outcomes.

The candidate, MBS2320, is a first-in-class investigational drug which is currently in clinical development for the treatment of rheumatoid arthritis (RA). It has already demonstrated a unique profile; reducing inflammation and supporting the remodelling of damaged bone.

Furthermore, in models of IPF, MBS2320 has shown a similarly unique profile, reducing symptoms of IPF while also supporting remodelling of fibrotic tissue.

The FDA has also designated MBS2320 as an orphan drug for the treatment of IPF. This category makes Istesso eligible for development incentives, including FDA assistance with clinical trial costs and seven years of market exclusivity in the US, should the treatment go on to gain market approval.

Dr Lisa Patel, chief executive officer and co-founder of Istesso, explained: “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,” she added.

A clinical study in patients with IPF will commence in 2023.