Poolbeg Pharma PLC (AIM:POLB) highlighted the opportunity for its lead drug as it reported first-half results, which also showed a cash balance of £10.1 million at the end of June.
Lead programme POLB 001 is positioned to be the first approved therapy that offers both prevention and treatment options to prevent a cytokine storm in patients receiving cancer immunotherapy, with independent research outlining a potential market opportunity of around US$10 billion.
During the period, the company strengthened its patent and overall intellectual property portfolio with positive in vivo data, with the US Patent Office granting an Immunomodulator II patent application covering a class of drugs, including POLB 001, to treat or prevent hypercytokinemia (cytokine storm) induced in any disease indication
Engagement also continued with potential partners in relation to POLB 001, said chief executive Jeremy Skillington, "seeing significant interest".
He said the value and attractiveness of POLB 001 to pharma partners had been "greatly enhanced" following the independent confirmation of the potential market opportunity.
"As pharma companies seek to enhance the safety and market reach of their cancer immunotherapies, we believe that POLB 001 is well placed to generate value for shareholders while addressing a critical unmet medical need for patients."
Skillington added that Poolbeg's increasing focus on rare and orphan diseases is exemplified by the exclusive 12-month option agreement signed for tPTX, a novel, topical treatment for oral ulcers in patients suffering from Behçet's Disease, which has US regulatory fast-track and orphan drug designation.
"Our experienced team, bolstered by the addition of a number of the former Amryt leadership team, is well-positioned to execute on our strategy of acquiring, developing, partnering, and commercialising innovative medicines that will help improve the lives of patients with rare and orphan diseases, and where there is a high unmet medical need."
Events coming up later this year, include the start of a clinical trial for a potential obesity treatment, an orally-delivered GLP-1R in the same market as those made by Novo Nordisk (NYSE:NVO) and Eli Lilly, which is expected to begin towards the end of 2024.
Poolbeg noted that despite extremely strong demand for the larger players in this new weight loss market, oral GLP-1R options are limited, with only one available drug offering just 1% bioavailability.
"Our Oral GLP-1R agonist programme aims to address this unmet need using a delivery system that utilises Generally Regarded as Safe (GRAS) components to encapsulate API's (active pharmaceutical ingredients), such as GLP-1R agonist, for oral delivery to specific areas of the gut and into systemic circulation with the aim of enhancing bioavailability and improving convenience."
Poolbeg said its £10.1 million cash balance was a result of its prudent financial management. It followed a period when it made a loss of £2.3 million as £0.7 million was spent on R&D, £2.1 million on administrative expenses, where there were tax rebates and other income & charges of £0.6 million.