Poolbeg Pharma shares soar on successful POLB 001 human trial
(), a clinical stage infectious disease company, announced results from the human challenge trial for its flagship POLB 001 candidate for severe influenza.
Poolbeg said the data from the LPS human challenge trial for POLB 001 indicated the treatment was "safe and well tolerated and had a potent effect in systemic and localised inflammatory response in a dose dependent manner."
The trial involved 36 healthy volunteers aged 18 to 55. The subjects exhibited a "marked reduction in multiple markers of systemic and localised inflammation compared with placebo", Poolbeg explained.
Specifically, the typical LPS-induced rise in plasma cytokine levels (TNF-α, IL-6, and IL-8) decreased between 57-81% across all cytokines in subjects treated with 70 mg or 150 mg POLB 001. POLB 001 also proved highly effective in blocking local inflammation.
Jeremy Skillington, PhD, CEO, commented: "Together these data indicate POLB 001 reaches all cells and tissues where p38 MAPK is expressed, shutting down inflammation and silencing multiple aspects of overactivated inflammation unlike many anti-inflammatory drugs that target a single immune pathway."
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This is an excellent result from Poolbeg Pharma's POLB 001 candidate for severe influenza. To put it in layman's terms, the human challenge trial has indicated that POLB 001 significantly reduces inflammation both locally and systematically in a way that is a market first.
Indeed, no other effective treatment currently exists for patents with severe influenza that are past the anti-viral stage and undergoing hospital treatment. Today, all that can be done for such patients is to treat their symptoms. POLB 001 promises to be the first effective drug for the condition.
This in part explains the market's strong reaction to the news, driving shares up as much as 30% today.
POLB 001's applications do not end with severe influenza, however. The treatment works on p38 MAP kinease, a master regulator of immunity, which plays a role in other inflammatory conditions. This makes POLB 001 an effective treatment for a range of acute, aggressive immune responses.
One example is hyperinflammation associated with cancer treatment. Last month we reported on Poolbeg's expansion of POLB 001 into oncology. While investigating the role of cytokine release syndrome (CRS) in severe influenza, Poolbeg discovered data suggesting that POLB 001 has the potential to dampen hyperinflammation associated with CRS that affects patients receiving CAR T-cell cancer therapies. CAR T-cell therapies are a form of cancer immunotherapy, and CRS is an often encountered side effect that causes potentially life-threatening hyperinflammation.
Poolbeg said it is readying oncology clinical trials, expecting trials in CAR T-cell patients to commence in 2024. Poolbeg said it will issue further oncology-related data, regulatory feedback, and non-clinical development updates later in 2023. It has already submitted a patent application for the use of POLB 001 in addressing the impact of CRS in CAR T-cell patients.
Overall, POLB 001 has the potential to be a highly disruptive treatment for severe influenza and other acute inflammatory conditions, answering significant unmet medical need. Due to its mode of action, it is strain agnostic and unaffected by seasonal variants. Furthermore, as a shelf stable oral drug it is an ideal stock piling candidate for both seasonal and pandemic outbreaks.
Poolbeg has been developing POLB 001 in accordance with its capital-light business model. Poolbeg aims to develop and bring products through to early human proof of concept in the clinic, then partner with large pharma and biotech companies that continue the pipeline to production and distribution. Thus, Poolbeg profits from the relatively inexpensive human trial process, now enhanced with their partners' AI analysis, and then exits at the scale-up stage.
Today's news should further accelerate Poolbeg's discussions with potential partners for POLB 001, with an agreement likely to be signed in 2023. Poolbeg is also targeting initial results from its AI collaboration with CytoReason in Q2 2023, as well as results from its GLP-1 oral vaccine trial in by Q4 2023. This leaves investors with much to look forward to this year. Poolbeg Pharma, so you do not miss future news.
Poolbeg remains well funded with a cash balance of £18.9m on 30 June 2022, enabling it to jump on high-value opportunities and quickly fund development. Its long development pipeline should continue to drive value for shareholders in 2023 and beyond. finnCap now places its risk-adjusted DCF valuation for POLB at 19p/share, up from 15p/share before today's news.
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