Poolbeg Pharma PLC (AIM:POLB) has inked an exclusive 12-month option agreement to acquire a phase III-ready treatment from Silk Road Therapeutics Inc that is being developed for oral ulcers associated with Behçet's Disease.
Interestingly, the topical muco-adherent formulation of Pentoxifylline (PTX) has acquired orphan drug and fast-track status from the US Food & Drug Administration.
These designations underline the drug's potential efficacy and safety and offer seven years of market exclusivity upon receiving marketing approval.
Additionally, the potential use of a 505(b)(2) approval pathway could significantly reduce the time and cost associated with bringing this much-needed medication to market.
"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 Poolbeg chief executive, Jeremy Skillington.
Behçet's Disease, characterised by chronic inflammation of blood vessels and tissues, manifests most commonly as painful oral ulcers severely affecting patients' quality of life and daily functions such as eating and speaking.
Despite the lack of a cure and satisfactory treatments, this new therapeutic has shown promise in phase II trials, outperforming the standard of care by accelerating healing and reducing pain in affected patients.
On a busy day for news from Poolbeg, the company also released its prelims. They revealed the drug developer exited the year ending December 31 with a cash balance of £12.2 million. It also posted a loss of £3.9 million as it invested in developing its key asset POLB 001, targeting inflammation.
The key highlight of the period was the recruitment of the Amryt Pharma team, which built and sold a drug business for $1.48 billion.
And, in a third announcement, investors were told Shore Capital Stockbrokers had been appointed joint broker to the company.