IP Group plc (IPO.L), a developer of science and technology businesses, Monday noted that its portfolio company Istesso Ltd.'s investigational metabolic reprogramming agent, MBS232, has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration or FDA. The designation has been received for the treatment of patients with idiopathic pulmonary fibrosis or IPF.
IPF is a progressive, life-threatening disease characterized by scarring of the lungs.
Istesso, an immunometabolism drug discovery and development company, will start a clinical study in patients with IPF in 2023. IP Group has an undiluted holding of 56% in Istesso.
MBS2320 is a first-in-class investigational drug which is currently in clinical development for the treatment of rheumatoid arthritis or RA. In models of IPF, MBS2320 has shown a unique profile, reducing symptoms of IPF while also supporting remodelling of fibrotic tissue.
The company noted that 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 FDA has also designated MBS2320 an orphan drug for the treatment of IPF. With this designation, Istesso is 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.
Lisa Patel, CEO and co-founder 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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