Poolbeg Pharma POLB 001 LPS human challenge clinical trial successfully completed

Poolbeg Pharma plc (LON:POLB’), a leading infectious disease focused biopharmaceutical company, has announced that, further to its announcement in July 2022, it has now received the initial results having completed the Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a viral strain agnostic, small molecule immunomodulator being developed to address the unmet medical need for severe influenza.

Key highlights from the study:

·     No further clinical activity is required to complete the objectives of the trial, bringing the recruitment and clinical phase to a close on schedule

·    No serious adverse events reported. POLB 001 was found to be safe and well tolerated

·     Data analysis has commenced and full data read-out is expected in Q2 2023

·    The comprehensive dataset is expected to facilitate progression of the product to the next clinical phase for potential partners

This LPS challenge trial was designed to evaluate the effect of POLB 001 on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following an intradermal and an intravenous LPS challenge. LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases.

POLB 001 is a unique potential treatment for viruses such as severe influenza as it is strain agnostic, unlike other flu treatments and prophylactics. This means that it can be effective regardless of which strain of influenza is dominant in any particular season or geography. As a shelf-stable, oral drug it could also be ideal as a stockpiling candidate for both seasonal outbreaks and pandemic preparedness.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

We have completed our first trial on schedule, achieving a key milestone for Poolbeg, thanks to the committed efforts of the team. We are actively planning the next steps for POLB 001 and are engaging with industry on potential partnering opportunities.

“The threat of influenza shouldn’t be underestimated. Cases are on the rise – the WHO estimates that there are 3-5 million severe influenza cases globally per year, with real pandemic potential. Severe influenza can also lead to other major complications such as pneumonia and stroke. There is a significant unmet need for severe influenza treatments, so we eagerly anticipate the full results of this study next year.”

Matthijs Moerland, PhD, Principal Investigator at CHDR, said:

“LPS human challenge trials are a highly reliable way of measuring the efficacy of anti-inflammatory drugs and these initial data are an important first step.  We are pleased to be involved in the development of a potential treatment for such an unmet need as severe influenza and we look forward to the vital insights that the full analysis will bring.”

Click to view all articles for the EPIC:
Or click to view the full company profile:
Poolbeg Pharma

More articles like this

Poolbeg Pharma publishes Annual Report and AGM Notice

Poolbeg Pharma plc (LON: POLB, OTCQB: POLBF), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, has confirmed that the Company’s Annual Report and Accounts for the period ended

Poolbeg Pharma expands treatment into new markets

Poolbeg Pharma said it had made progress last year in expanding its treatments into new markets, with significant pipeline advancements and strategic deals. The company said it had made a strategic expansion into the treatment of

Poolbeg Pharma granted significant POLB 001 patent in United States

Poolbeg Pharma plc (LON:POLB, OTCQB:POLBF), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, has announced that, further to its announcement on 20 March 2024, the Company has received the fully granted

AI impact on biopharma business models

The culture of collaboration in the Pacific Northwest, the impact of AI on biopharma, and the shape of new business models driven by AI were all topics at a panel discussion Wednesday in Seattle at the

POLB 001: Targeting CRS in Cancer Immunotherapy

Phase 2 Ready orally administered p38 MAP Kinase inhibitor – a preventative therapy targeting an addressable market of more than $10 billion. POLB 001 aims to target the Cytokine Release Syndrome (CRS) associated with many cancer

Poolbeg Pharma updates on Immunomodulator II Patent

Poolbeg Pharma has announced that it has received a Notice of Allowance from the US Patent Office in relation to its Immunomodulator II patent application. A Notice of Allowance is a precursor to the expected formal grant

February hires in Pharma

February may be the shortest month, but we got an extra day this year and that left plenty of time for personnel announcements in the pharma world. Read on for a roundup of the month’s hiring