Poolbeg ready to commence POLB 001 clinical study
Poolbeg Pharma is to commence a human challenge trial for its lead molecule POLB 001, a small molecule immunomodulator intended for the treatment of severe influenza, marking delivery against an important commitment made in its IPO a year ago. The company has received ethics and competent authority approval for the study and expects to carry out the formal site initiation visit later this week. The study will be conducted at the CHDR, an independent institute in the Netherlands specialising in early clinical trials.
The study will test POLB 001, an in-licensed p38 MAPK inhibitor, in a condition that mimics the hyper-inflammatory response (cytokine storm) that can occur in influenza. The study will be conducted in healthy volunteers, where the symptoms are triggered by exposure to LPS (lipopolysaccharide), a cell surface molecule produced by most Gram-negative bacteria.
Thestudy is randomised, double-blind and placebo-controlled and tests multiple doses in 36 healthy volunteers challenged with LPS administered both intradermally and intravenously. There will be three cohorts with escalating dose (30mg, 70mg, 150mg), with 12 volunteers per treatment group (3:1 drug: placebo) with the study drug administered orally, twice daily for seven consecutive days.
The endpoints are as follows: for intradermal (skin response by imaging, blister exudate analysis, skin punch biopsy, safety and tolerability) and for IV are bloods (cytokines, vascular markers, CRP), ex-vivo LPS response and safety & tolerability (including vital signs, AEs, ECG and haematology). It is hoped the study will show a dose-dependent reduction in the inflammatory response.
Initial results are expected before the end of 2022, after which Poolbeg aims to secure a licensing deal for the further development of POLB 001. The company expects that this study, when combined with data from earlier studies conducted by a prior licensor, will provide a broad data package that should be attractive to potential partners. The company is exploring further disease indications and the results from this study could provide insights in these indications.
Final regulatory clearance to start LPS challenge trial
Poolbeg reported cash of £20.9mln at the end of December. Based on the current market capitalisation (£23mln), it has an enterprise value of no more than £5mln, making an assumption of costs in the first half of the year. This represents a potentially attractive entry point for investors, considering Poolbeg has a pipleine with one clinical stage asset and at least four preclinical programmes (including two based on recently-established artificial intelligence data collaborations), all addressing unmet needs in infectious disease.
EV very attractve currently
Recent grant of patents
In May, Poolbeg reported the grant of two US patents. These cover POLB 001 and POLB 002, its intranasally administered RNA-based immunotherapy for respiratory virus infections. The first patent (No 11,339,207) was issued to Poolbeg and covers the use of certain p38 MAP kinase (mitogen-activated protein kinase) inhibitors, including POLB 001, for the treatment or prevention of severe influenza and its associated hypercytokinaemia (cytokine storm) through modulation of the immune response. Poolbeg noted the patent covers for the majority of its original claims and that its plans to further strengthen its IP position, through continuation patent application(s).
The second patent (No 11,339,374) was issued to the University of Warwick, to which Poolbeg is an exclusive licensee, covering the identification of defective interfering (DI) RNA-based influenza viruses for use against infection by influenza. This is the basis for POLB 002, which is a DI virus with a dual mechanism of action that interferes with virus replication and triggers nasal cells to go into an antiviral state. POLB 002 could have both prophylactic and therapeutic applications and provide pan-viral protection from respiratory virus infections including influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others. The candidate is currently is in late preclinical development.