Dublin-based infectious disease specialist Poolbeg Pharma has received data analysis in relation to a new drug to treat the unmet medical need for severe flu. The data indicated that administration of the drug during a clinical trial resulted in a marked reduction in both systemic and localised inflammatory response in subjects challenged with bacterial lipopolysaccharide (LPS) compared to those who received a placebo.
A clear dose-response relationship was also apparent. This trial was designed to evaluate the effect of the drug on inflammatory responses in 36 healthy volunteers between 18 and 55 years of age following both an intradermal and an intravenous LPS challenge.
LPS acts as a surrogate for the hyperinflammatory response associated with severe influenza and other diseases. The drug was well tolerated across all doses and no serious adverse events or volunteer withdrawals were reported.
Poolbeg Pharma chief executive Jeremy Skillington said: “Following the completion of the LPS human challenge trial in December, we are excited to see this positive initial data. The clear anti-inflammatory dose response, with no serious adverse events, further demonstrates the strong potential for [the drug] to address the significant unmet medical need in severe influenza and beyond.
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“We are delighted to have completed our first clinical trial on schedule, delivering on our business model of rapidly generating early human clinical data. We believe that the positive initial data is a significant value inflection point and will support discussions with partners.”
The drug is a small molecule immunomodulator for the treatment of hypercytokinemia-related diseases such as severe influenza. It electively inhibits overwhelming inflammation in viral infections, such as influenza, while leaving the necessary immune functions intact to fight the infection. This contrasts with other immunomodulatory approaches, such as steroids, which affect both beneficial and damaging immune responses.
It is unaffected by seasonal variants which is a significant advantage over treatments available on the market. In addition, as a shelf stable oral drug it is “an ideal stockpiling candidate” for both seasonal and pandemic outbreaks.
Poolbeg said it has the potential to be a transformational treatment for patients and to become a leading severe influenza treatment.
