Poolbeg agrees 12-month option over potential Behcet's treatment

Poolbeg Pharma announced an exclusive 12-month option agreement with Silk Road Therapeutics on Tuesday, to potentially acquire a novel topical muco-adherent formulation of Pentoxifylline (tPTX).

The AIM-traded firm said the formulation targeted oral ulcers in patients grappling with Behçet's Disease, a condition marked by a high unmet medical need due to its lack of a cure.

Highlights of the agreement included the successful completion of a phase two trial, which demonstrated the superiority of tPTX over the current standard of care.

Moreover, the drug had garnered both orphan drug designation and fast-track designation from the FDA, setting the stage for a potential approval pathway in the US.

The board said the partnership with Silk Road Therapeutics would enable Poolbeg to further its due diligence efforts, including engagement with Silk Road to determine the clinical approval pathway.

That came amid clear demand for effective treatments for Behçet's Disease, which sees inflammation of blood vessels and tissues, leading to debilitating symptoms such as oral ulcers.

The current standard of care fell short, leaving a pressing need for alternative treatment options.

The topical formulation of PTX had shown promising results in accelerating oral ulcer healing and reducing pain in Behçet's Disease patients during clinical trials.

“The foundation of any pharma company is a strong pipeline of assets, and we believe that topical PTX could fit well into our pipeline alongside our other assets as we increase our focus on rare and orphan diseases,” said chief executive officer Jeremy Skillington.

“We are delighted to enter this exclusive option agreement with Silk Road Therapeutics and Dr Timothy Coté, whose extensive experience, including as director of the FDA Office of Orphan Products Development, adds invaluable insights into the regulatory pathway and ultimate approval and commercialisation of the drug.”

Skillington dded that tPTX had the potential to “transform the lives” of patients suffering from Behçet's Disease, who currently lacked effective and safe long term treatment options.

“Under this exclusive option agreement, we will advance our due diligence process and engage with Silk Road Therapeutics to further understand the clinical pathway to approval, and we look forward to updating the market in due course.”

At 1623 BST, shares in Poolbeg Pharma were up 8.04% at 12.1p.

Reporting by Josh White for Sharecast.com.