Regulatory approval gives green light for LPS trial to proceed
Poolbeg Pharma, a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, has received ethics and competent authority approval to commence its Lipopolysaccharide (LPS) human challenge clinical trial for POLB 001, a strain agnostic, small molecule immunomodulator which aims to address the unmet medical need for a treatment for severe influenza.
Key highlights:
- The trial will assess the efficacy of POLB 001 in dampening the robust immune response to LPS which acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases.
- Initial results expected in Q4 2022 at which point the company intends to rapidly monetise by out-licensing / partnering with pharma and biotech companies for further development of POLB 001.
- Trial success could also pave the way for potential applications beyond severe influenza.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This is a major milestone for Poolbeg as we are ready to commence the LPS human challenge trial of POLB 001, our severe influenza treatment. Significant preparatory work has been completed in order to reach this stage with the completion of GMP manufacturing, formulation, trial protocol design amongst other vital regulatory requirements.
"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.
“The unmet need for new treatments for severe influenza presents a significant opportunity to improve outcomes for patients as well as to potentially rapidly monetise our lead asset. The unique mode of action of POLB 001 to reduce hyperinflammatory response in the body means that it is agnostic to the strain of virus and has the potential to expand to other disease indications and as such, could provide further opportunities to create significant value beyond severe influenza for the company and our shareholders.”