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EDINBURGH, Scotland–(BUSINESS WIRE)–Jun 22, 2026–
Pheno Therapeutics Cramped. (Pheno), a clinical stage biotechnology company centered on the discovery and charm of small molecule therapeutics for the medication of neurological ailments, at present introduced that the US Meals and Drug Administration (FDA) has cleared the Investigational Unique Drug (IND) application for PTD802, the Firm’s lead therapeutic candidate. The clearance enables Pheno to proceed with a valuable-in-human clinical trial of PTD802 within the US.
The announcement follows the Firm’s clinical trial authorisation (CTA) from the UK’s MHRA in January 2025 1. The first-in-human scrutinize would withhold in options the security and tolerability of PTD802 in wholesome volunteers. PTD802 is a unique small molecule therapeutic designed to promote remyelination, with an initial agree with extra than one sclerosis (MS), a neurological disease with high unmet clinical need.
Developed below an out of the ordinary worldwide licence from UCB, PTD802 is a selective GPR17 (G protein-coupled receptor 17) antagonist, and is the principle GPR17 programme to receive IND clearance, handing over a recent class of neuroprotective therapeutics. This style also helps Pheno Therapeutics’ IP build of abode within the US.
In MS, the immune machine assaults and damages the myelin sheaths that insulate and nourish axons and nerve fibres within the central apprehensive machine, leading to multifocal demyelination, axonal harm, and neurodegeneration. The disease is in total associated with a huge different of neurological symptoms, which, despite the ability of existing medication to govern the inflammatory element, can growth to total physical and cognitive incapacity.
Fraser Murray, PhD, CEO, Pheno Therapeutics, acknowledged:
“FDA IND clearance is a truly critical milestone for our PTD802 programme, and a step extra in opposition to our final map of providing an efficient medication for neurological ailments associated with demyelination. As the principle company to manufacture approval to originate clinical trials for a selective GPR17 antagonist, we are proud to be leading the near, and maintain this near has the aptitude to provide precise patient profit, in MS and previous.”
Belief provide model on businesswire.com:https://www.businesswire.com/news/home/20260622772175/en/
CONTACT: Zyme Communications
Katie Odgaard
KEYWORD: UNITED KINGDOM EUROPE
INDUSTRY KEYWORD: SCIENCE NEUROLOGY BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH FDA CLINICAL TRIALS
SOURCE: Pheno Therapeutics
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PUB: 06/22/2026 04:01 AM/DISC: 06/22/2026 04:01 AM
http://www.businesswire.com/news/home/20260622772175/en
