GCIPoolbeg Pharma sees positive initial data from influenza candidate trial
( ), a clinical stage infectious disease company, announced positive initial data from the human challenge trial for its flagship POLB 001 candidate for severe influenza.
Poolbeg said the data indicated that administration of POLB 001 resulted in a "marked reduction" in both systematic and localised inflammatory response in subjects challenged with bacterial lipopolysaccharide (LPS) compared to those who received a placebo.
The LPS challenge trial evaluated the effect of POLB 001 on 36 volunteers aged 18-55, following both an intradermal and intravenous LPS challenge. In the study, LPS acted as a surrogate for the hyperinflammatory response associated with severe influenza.
Poolbeg said POLB 001 was "well-tolerated across all doses and no serious adverse events or volunteer withdrawals". Poolbeg also confirmed that a clear dose-response relationship was apparent.
Jeremy Skillington, CEO, commented:
"Following the completion of the LPS human challenge trial in December, we are excited to see this positive initial data of POLB 001. The clear anti-inflammatory dose response, with no serious adverse events, further demonstrates the strong potential for POLB 001 to address the significant unmet medical need in severe influenza and beyond. We look forward to presenting the full data in Q2 2023."
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Markets had been looking forward to results from Poolbeg's first clinical trial for POLB 001, and initial data did not disappoint - shares were up 10.27% on the news in early trading on Monday.
In summary, the data showed that POLB 001 was effective in reducing both systemic and localised inflammatory response, with a clear dose-response relationship. It was well-tolerated across all doses without serious adverse side effects of volunteer withdrawals.
Poolbeg said the full data would be released in Q2 2023.
POLB 001 has the potential to be a disruptive treatment for influenza, answering significant unmet medical need. Due to its mode of action, it is strain agnostic and unaffected by seasonal variants, which is a notable advantage over its competitors. 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 accelerate Poolbeg's discussions with potential partners for POLB 001.
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. The company's long development pipeline will continue to drive value for shareholders in 2023.
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