Argo Biopharmaceutical announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its novel siRNA therapy BW-20805, for the treatment of hereditary angioedema (HAE).

BW-20805 is an investigational siRNA therapy that targets and significantly inhibits prekallikrein (PKK), a well-validated target for hereditary angioedema (HAE) treatment, offering the possibility of prevention of HAE attacks with a long-term effect. The company is currently conducting a global phase-II study in adult HAE patients. It anticipates primary completion of the phase-II study in the second half of 2026, followed by plans for a global phase-III study.

"Receiving FTD from the FDA highlights the significant unmet medical need for patients living with HAE and underscores the potential of BW-20805 as a novel therapeutic option. We have generated a robust body of clinical evidence supporting BW-20805's potential, including recent open-label study results presented at the AAAAI Annual Meeting, which demonstrated that BW-20805 provides remarkable plasma PKK reduction and meaningful time-normalised HAE attack rate reduction. We look forward to advancing the clinical development of BW-20805 and bringing a potentially long-acting treatment option to patients as effectively as possible," said Dr Dongxu Shu, Co-Founder and Chief Executive Officer (CEO), Argo Biopharma.