On March 16, Bowang Pharmaceutical announced that its investigational siRNA therapy BW-20805 received Fast Track designation from the U.S. FDA for the treatment of hereditary angioedema (HAE).

HAE is a rare genetic disorder that causes sudden, unpredictable swelling in different parts of the body. Severe cases can lead to laryngeal edema, with a mortality rate as high as approximately 40%.

BW-20805 is an siRNA therapy targeting prokallikrein (PKK). By targeting PKK mRNA and inhibiting PKK gene expression, it holds promise for providing long-term flare prevention for patients with heart attack (HAE). PKK is currently a well-established therapeutic target in HAE treatment. Recent data presented by Bowang Pharmaceuticals at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting showed that BW-20805 significantly reduces plasma PKK levels and achieves a clinically significant reduction in HAE flare rates.

Bowang Pharmaceuticals is currently conducting a Phase 2 clinical trial in adult HAE patients, and expects to complete the Phase 2 clinical trial in the second half of 2026, followed by the initiation of a Phase 3 clinical trial.

https://mp.weixin.qq.com/s/73pdstKEgs3qDjNvOPSASw