Shares in Poolbeg Pharma PLC (AIM:POLB) rose 11% on Tuesday after the US Food and Drug Administration granted Orphan Drug Designation to its lead candidate, POLB 001. The drug is being developed to prevent cytokine release syndrome, a severe and potentially fatal side-effect linked to some advanced cancer immunotherapies.
The designation, reserved for treatments targeting rare diseases, gives Poolbeg access to a series of incentives in the United States. These include tax credits, reduced regulatory fees and a potential seven-year period of market exclusivity if the drug is approved.
POLB 001 is taken orally and works by blocking a protein known to drive the intense immune response that causes cytokine release syndrome. Mid-stage trials are expected to begin later this year.
Poolbeg said larger pharmaceutical firms have shown interest in supplying the antibodies needed for the trial, which would help lower costs. There are currently no approved drugs that prevent the condition.
The shares rose 0.28p to 2.73p.