Poolbeg Pharma releases positive data from influenza trial

Poolbeg Pharma has released new data from a human challenge trial that shows its treatment has strong potential in dampening inflammation in blood and tissues in influenza and other viral infections.

POLB 001 showed success in reducing multiple markers of systemic and local inflammation compared with placebo, and a significant reduction in p38 MAP kinase-driven cytokines. Cytokines can sweep throughout the body and cause tissue damage and shut down circulation and other essential organs.

POLB 001 is a viral strain agnostic, small molecule immunomodulator being developed to address severe influenza and other acute inflammatory conditions. The treatment differs from other approaches, such as steroids, which can affect both beneficial and damaging immune responses. It is also unaffected by seasonal variants, giving it an advantage over other treatments on the market, and is a shelf-stable oral drug.

“Together, these data indicate POLB 001 reaches all cells and tissues where p38 MAPK is expressed, shutting down inflammation and silencing multiple aspects of overactivated inflammation unlike many anti-inflammatory drugs that target a single immune pathway,” said Poolbeg Pharma chief executive Jeremy Skillington.

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“POLB 001 blocks inflammation both locally and systemically and in a manner that suggests efficacy in treating life-threatening infections such as severe influenza or the CRS associated with other acute inflammatory conditions. POLB 001 has the potential to be an effective treatment in a wide range of inflammatory syndromes that present serious and life-threatening complications for patients.

“Due to our parallel clinical programmes with POLB 001, we are particularly excited that these results support continued clinical investigation in both indications, and that we can share this positive data with potential pharma partners ahead of schedule.”

The Covid-19 pandemic, more than anything in recent memory, has shown how bereft we are of the medicines needed to treat infections

The trial, which was conducted at the Centre for Human Drug Research in the Netherlands, included 36 healthy volunteers aged 18 to 55. It used a bacterial product that mimics infection and can capture the hallmarks of both local and systemic inflammation typical of a cytokine storm in humans in a safe, controlled and quantifiable manner.

“The Covid-19 pandemic, more than anything in recent memory, has shown how bereft we are of the medicines needed to treat infections, and stop our immune system from killing us,” said Derek Gilroy, professor of immunology at University College London. “With such pandemics increasing in frequency, it’s only a matter of time before we face yet another crisis.

“Poolbeg Pharma has risen to this challenge. POLB 001 has shown substantial promise in dampening the key players of harmful inflammation in both blood and tissues, acting where the immune system can do harm. These exciting data, and safety profile, support a role for POLB 001 beyond infectious diseases into treating a range of acute, aggressive immune responses.”