The US Food and Drug Administration (FDA) has granted Fast Track designation to FNP-223, a promising investigational drug developed by Ferrer, a B Corp-certified pharmaceutical company, for the treatment of progressive supranuclear palsy (PSP). This rare and aggressive neurodegenerative disorder affects balance, speech, and cognitive functions, and currently has no approved disease-modifying therapies.
FNP-223, which Ferrer in-licensed from Swiss biotech company Asceneuron, is a novel molecular entity designed to slow the progression of PSP. The drug is currently undergoing Phase 2 clinical trials to assess its safety, efficacy, and pharmacokinetics in adult patients diagnosed with PSP-Richardson syndrome (PSP-RS), the most common and severe clinical subtype of PSP.
In announcing the news, Mario Rovirosa, CEO of Ferrer, stated:
“We are thrilled to receive Fast Track designation from the FDA for FNP-223 in the treatment of PSP. Consistent with our purpose of using business to fight for social justice, we are committed to advancing this promising therapy as quickly as possible to benefit as many patients as possible.”
The FDA’s Fast Track program is intended to speed up the development and review of drugs that treat serious conditions and fill an unmet medical need. It enables more frequent communication with the agency, eligibility for Accelerated Approval, and Priority Review if criteria are met.
Marta Parmar, Ferrer’s Chief Quality, Regulatory and Pharmacovigilance Officer, added:
“This designation underscores the importance of expediting the development and review of FNP-223 to address critical unmet needs in patients with this rare and devastating disease.”
PSP affects approximately five in 100,000 people, primarily those over the age of 60. Its pathology is linked to the abnormal accumulation of tau proteins in specific brain regions, resulting in progressive deterioration of motor and cognitive abilities. Preclinical studies of FNP-223 have shown it can potentially prevent the buildup of tau proteins, offering hope for a therapy that can modify the course of the disease rather than just manage its symptoms.
Ferrer’s Chief Scientific Officer, Oscar Pérez, described the designation as a “significant milestone,” and emphasized the company’s commitment to rapidly advancing research that could lead to a transformative treatment for PSP.
The company’s efforts align with its broader mission to promote social impact through healthcare innovation, offering novel solutions to underserved patient populations worldwide. If successful in ongoing trials, FNP-223 would become a first-in-class treatment for PSP, a disease long neglected in the landscape of neurological research.
