LONDON, UK – Poolbeg Pharma (AIM:POLB)(OTCQB:POLBF), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces that it has entered into an exclusive 12-month option agreement with Silk Road Therapeutics Inc, for a nominal fee, to acquire a novel topical muco-adherent formulation of Pentoxifylline (tPTX) for the treatment of oral ulcers in patient’s suffering from Behçet’s Disease.
Key Highlights
12-month option agreement with Silk Road Therapeutics to acquire novel topical muco-adherent formulation of Pentoxifylline (tPTX), a treatment for oral ulcers in patient’s suffering from Behçet’s Disease which currently has no cure
Phase 2 trial successfully completed, demonstrating superiority over standard of care
Secured Orphan Drug Designation and Fast Track Designation from the FDA
Positioned for a potential 505(b)(2) approval pathway in the U.S.
Poolbeg will continue due diligence throughout the term of the exclusive option agreement which will include engagement with Silk Road Therapeutics to ascertain the clinical approval pathway
There is a clear unmet medical need for an effective treatment for this rare disease, which has no cure. Behçet’s Disease causes inflammation of blood vessels and tissues, resulting in debilitating symptoms, the most common being oral ulcers which impact essential functions like eating, drinking and speaking.[1] Patients also suffer from reduced psychosocial quality of life[2]. Current standard of care is inadequate with safety concerns and there is a clear need for alternative treatment options.
The topical formulation of PTX, a small molecule with broad anti-inflammatory activity, has successfully demonstrated accelerated oral ulcer healing and decreased pain compared to standard of care in patients with Behçet’s Disease in a Phase 2 clinical trial.
The drug is positioned for a potential 505(b)(2) approval pathway in the U.S. which can result in a much less expensive and much faster route to approval and commercialisation. tPTX has successfully secured FDA Fast Track Designation, designed to expedite development and review of certain medicines. It has also received Orphan Drug Designation from the FDA, providing seven years of market exclusivity upon marketing authorisation.
Jeremy Skillington, PhD, Chief Executive Officer of Poolbeg Pharma, said: “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.
“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.
“tPTX has the potential to transform the lives of patients suffering from Behçet’s Disease, who currently lack 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.”
Timothy R. Coté, M.D., M.P.H., Chief Executive Officer of Silk Road Therapeutics, said: “Poolbeg Pharma shares our commitment to advancing healthcare innovation to support rare disease patients. With Fast Track Designation and Orphan Drug Designation secured, topical PTX has the potential to swiftly reach patients and offer a potentially transformative solution for those suffering from Behçet’s Disease.”
Investor presentation
Poolbeg Pharma CEO, Jeremy Skillington, PhD, and CBO David Allmond, along with Dr Timothy Coté, CEO of Silk Road Therapeutics,will provide a live presentation via the Investor Meet Company platform on Tuesday 30 April 2024 at 6pm BST.
The presentation is open to analysts and investors, those who already follow Poolbeg on the Investor Meet Company platform will automatically be invited. Investors can sign up to Investor Meet for free and add Poolbeg Pharma plc to their company dashboard via: https://www.investormeetcompany.com/poolbeg-pharma-plc/register-investor
Enquiries
| Poolbeg Pharma Plc
Jeremy Skillington, CEO Ian O’Connell, CFO |
+44 (0) 207 183 1499 |
| Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker)
Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) |
+44 (0) 207 220 0500 |
| Singer Capital Markets (Joint Broker)
Phil Davies, Sam Butcher |
+44 (0) 207 496 3000 |
| J&E Davy (Joint Broker)
Anthony Farrell, Niall Gilchrist |
+353 (0) 1 679 6363 |
| Optimum Strategic Communications
Nick Bastin, Vici Rabbetts, Elena Bates |
+44 (0) 208 078 4357 |
About Behçet’s Disease
Behçet’s Disease is a rare condition that results in inflammation of the blood vessels and tissues. Inflammation across multiple parts of the body leads to diverse symptoms, the most prevalent being recurrent oral ulcers, in addition to genital ulcers and inflammation of the eye and skin lesions. It is not yet known what triggers the disease or causes it to persist. However, it is clear there is a significant immune component with some suggestions that exaggerated responses to pathogens and increased cytokine and chemokine production may play key roles in the disease.[3]
About Poolbeg Pharma
Poolbeg Pharma plc is committed to the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, with a growing emphasis on rare and orphan diseases. Its model focusses upon developing its exciting clinical assets and commercialising approved and marketed drugs to support the growth of the Company and the development of its robust pipeline of innovative products, thereby driving significant value creation.
Poolbeg is led by an experienced leadership team with a history of delivering significant shareholder value. The team has been strengthened by the appointment of three former members of the Amryt Pharma plc leadership team, with the intention of repeating Amryt’s success and generating near term revenues.
Poolbeg’s clinical programmes target large addressable markets including cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions such as obesity with the development of an oral GLP-1R agonist. It uses a cost-effective development philosophy to generate high quality human data to support partnering and further development. Its AI-led infectious disease programmes analyse unique data from human challenge trials to identify clinically relevant drug targets and treatments, leading to faster development and greater commercial appeal.
References
[1] Hatemi G, Yurttas B, Kutlubay Z, Cote T, Derkunt S, Yazici Y, Yazici H. Pentoxifylline Gel for Oral Ulcers in Patients with Behçet’s Syndrome [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/pentoxifylline-gel-for-oral-ulcers-in-patients-with-behcets-syndrome/. Accessed April 17, 2024.
[2] Ali S, Nagieb CS, Fayed HL. Effect of Behcet’s disease-associated oral ulcers on oral health related quality of life. Spec Care Dentist. 2023 Jul-Aug;43(4):435-442. doi: 10.1111/scd.12782. Epub 2022 Sep 20. PMID: 36127751.
[3] behcetsuk.org
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