Poolbeg Pharma's milestone POLB 001 trial receives regulatory green light
( ) has received regulatory approval to begin its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator treatment for severe influenza.
The trial will assess the efficacy of POLB 001 in dampening the body's robust immune response to LPS. LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases, which can lead to organ damage. The trial will officially commence on 22 July.
Initial results are expected in Q4 2022, at which point Poolbeg intends to partner with pharma and biotech companies for further development and monetisation of POLB 001. Success of the trial will pave the way for potential applications beyond severe influenza.
Jeremy Skillington PhD, CEO of Poolbeg Pharma, commented: "We look forward to receiving the valuable, broad-ranging data and insights that this trial is expected to generate by the end of 2022. We stated at our IPO in July 2021 that we intended to bring POLB 001 into the clinic for this LPS trial in the summer of 2022 and are happy to have achieved this stated objective and demonstrate our ability to effectively execute on our strategy."
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This is a significant milestone for Poolbeg which began preparatory work for this trial in 2021. There is an unmet need for treatment of severe influenza, thus a successful POLB 001 trial will present opportunities to quickly improve the lives of patients, and monetise Poolbeg's R&D for the treatment. Poolbeg was granted US patents for POLB 001 and POLB 002 in May.
The company is also investigating POLB 001's applications and potential value beyond severe influenza. POLB 001's ability to reduce hyperinflammation would be valuable in a wide range of applications and treatments.
Since the outbreak of Covid-19, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025. With its initial assets from Open Orphan, Poolbeg has targeted this growing market. Since its IPO a year ago, the company has made significant progress in developing new products - in addition to POLB 001 and POLB 002, Poolbeg has partnered with two leading AI firms for its RSV Artificial Intelligence Discovery Program.
Investors welcomed today's news with POLB shares up 6.19% in early trading.
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