Poolbeg Pharma (POLB) said its ongoing TOPICAL clinical trial of POLB 001 will continue as planned following a positive review of data from the interim safety cohort.
The review recommended that the study proceed without any changes to the trial protocol, marking an important milestone in the clinical development of POLB 001.
Patient recruitment is continuing across leading UK clinical sites, with further patients expected to be enrolled and additional sites activated.
POLB 001 is being developed as a potential preventative treatment for cytokine release syndrome (CRS), a potentially serious side effect associated with some cancer immunotherapies, including bispecific antibodies.
Poolbeg said it expects to generate further clinical data as the study progresses and plans to share additional details with prospective partners as discussions around POLB 001 continue.
Poolbeg Pharma’s Chief Executive Officer Jeremy Skillington said: “The data from the interim cohort represent a significant milestone for the TOPICAL trial. The positive recommendation to continue the study as planned provides further confidence as we advance the POLB 001 programme.
“We are building momentum across the study, with recruitment continuing at leading UK clinical sites, further patients expected to be enrolled and additional sites activated. We look forward to generating further clinical data and sharing more detail with prospective partners as we continue discussions around the POLB 001 opportunity.”
View from Vox
The positive interim safety review allows the TOPICAL trial to move ahead without protocol changes and removes an important near term clinical hurdle for POLB 001. Continued recruitment and the activation of additional UK sites should help Poolbeg build the clinical dataset needed to support ongoing discussions with prospective partners.