The clinical stage biotech Pheno Therapeutics has announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PTD802, the company's lead therapeutic candidate.
The news means Pheno can now proceed with a first-in-human clinical trial of PTD802 in the US and follows on from a clinical trial authorisation (CTA) from the UK’s MHRA in January 2025.
PTD802 is a novel small molecule therapeutic designed to promote remyelination, with an initial focus on multiple sclerosis (MS), a neurological disease with significant unmet medical need.
Developed under an exclusive worldwide licence from UCB, PTD802 is a selective GPR17 (G protein-coupled receptor 17) antagonist.
The first-in-human study would investigate the safety and tolerability of PTD802 in healthy volunteers.
This also marks the first GPR17 programme to receive IND clearance, delivering a new class of neuroprotective therapeutics, which Pheno Therapeutics said would support its IP position in the US.
Dr Fraser Murray, CEO at Pheno Therapeutics, said: "FDA IND clearance is an important milestone for our PTD802 programme and a step further toward our ultimate goal of providing an effective treatment for neurological diseases associated with demyelination."
As the first company to gain approval to begin clinical trials for a selective GPR17 antagonist, we are proud to be leading the way and believe this approach has the potential to offer real patient benefit, in MS and beyond.
