PTD802 is aimed at promoting remyelination in individuals with neurological conditions, particularly multiple sclerosis. Credit: New Africa/Shutterstock.

Pheno Therapeutics has gained clinical trial authorisation (CTA) from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its small molecule therapeutic, PTD802.

The authorisation enables the first-in-human trial of the selective G protein-coupled receptor 17 (GPR17) antagonist to proceed, which is aimed at promoting remyelination in individuals with neurological conditions, particularly multiple sclerosis (MS).

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Pheno Therapeutics CEO Fraser Murray said: “We are delighted to have received approval from the MHRA to progress our PTD802 programme to a Phase I trial, a major milestone, marking our transition to a clinical-stage organisation.

“As the first company to carry out dosing of a selective GPR17 antagonist in healthy humans, we are leading the way in the race to develop GPR17-targeting remyelination therapeutics. With this first-in-human programme, we are moving closer to our goal of delivering transformational drugs for the treatment of neurological diseases associated with demyelination.”

Developed under an exclusive worldwide licence agreement with UCB, a Belgium-based biopharmaceutical company, PTD802 is designed to counteract the effects of demyelination in MS.

This condition is characterised by the immune system attacking the myelin sheaths, leading to nerve damage and a range of neurological symptoms. Despite existing treatments that manage inflammation, MS can progress and cause severe physical and cognitive disability.

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Supported by biotech investors Advent Life Sciences and LifeArc, Pheno Therapeutics specialises in developing small molecule therapeutics that enhance the function of human oligodendrocytes.

Pheno stated that it brings together expertise in myelin biology, MS trials, patient selection, and clinical cohorts.

In January 2023, Pheno Therapeutics entered an exclusive worldwide licence agreement with UCB, granting Pheno the rights and access to develop, manufacture, and commercialise a preclinical-stage programme of novel small molecules focused on remyelination.