Poolbeg Pharma PLC (AIM: POLB, OTCQB: POLBF) has secured an exclusive 12-month option agreement with Silk Road Therapeutics Inc to acquire a phase III-ready oral ulcer treatment for Behçet’s Disease.
The treatment involves a topical muco-adherent formulation of Pentoxifylline (PTX), which has received orphan drug and fast-track designations from the US Food & Drug Administration. These statuses highlight the drug’s promising efficacy and safety and grant it seven years of market exclusivity upon approval.
Moreover, the potential application of a 505(b)(2) approval pathway could notably decrease the time and costs involved in delivering this critical medication to the market.
“Topical PTX could be a valuable addition to our focus on rare and orphan diseases, strengthening our portfolio,” commented Jeremy Skillington, CEO of Poolbeg.
Behçet’s Disease, known for chronic inflammation that often results in painful oral ulcers, severely compromises patients’ life quality, affecting daily activities like eating and speaking.
Although current treatments are limited, this new therapy has demonstrated significant promise in phase II trials, surpassing standard treatments by enhancing healing and reducing pain.
In other updates from Poolbeg, the company announced preliminary results showing a year-end cash balance of £12.2 million and a loss of £3.9 million due to investments in developing its primary asset, POLB 001, for inflammation.
A notable development in the period was the recruitment of the Amryt Pharma team, known for building and selling a drug business for $1.48 billion.
Additionally, Poolbeg announced the appointment of Shore Capital Stockbrokers as a joint broker to the company.
