Akeso, Inc. (9926.HK), a commercial-stage biopharmaceutical company, announced on Thursday that the National Medical Products Administration (NMPA) of China has approved Gumokimab for the treatment of adult patients with moderate-to-severe plaque psoriasis.
Plaque psoriasis is a common type of psoriasis that causes the skin to appear dry and itchy with plaques covered with scales. It is a chronic condition that tends to go through cyclic flare-ups for weeks or months. (Source: Mayo Clinic).
Gumokimab (AK111) is an Akeso-developed IgG1 monoclonal antibody that targets interleukin-17 (IL-17) for treating patients with autoimmune diseases such as psoriasis. Gumokimab is described to inhibit the progression of the immune-inflammatory response by blocking the IL-17/IL-17 receptor signalling pathway.
The approval was supported by one pivotal Phase 3 AK111-301 clinical study and three supportive studies.
Gumokimab is administered subcutaneously and requires only 17 injections per year, including the loading phase. According to Akeso, this represents approximately half the annual injection burden of other IL-17 inhibitors that require more frequent maintenance dosing.
The company stated that Gumokimab achieved a PASI (psoriasis area and severity index) 75 response rate of 94.6% and a complete skin clearance rate (PASI 100) of 47.7% at week 12. The result was substantially higher than the 28.6% PASI 100 response rate observed with other agents of the same class.
Additionally, the company noted the PASI 75 response rate approached 100% through week 52, while the PASI 100 response rate reached 68.9% compared to 39.2% reported for other drugs of the same class. The treatment demonstrated rapid onset of action, with meaningful improvement observed as early as Week 2.
Gumokimab demonstrated a favorable safety profile, with TEAE and SAE rates reported by the company as among the lowest observed across pivotal IL-17 inhibitor studies.
In addition to moderate-to-severe plaque psoriasis, a supplemental New Drug Application (sNDA) for gumokimab in active ankylosing spondylitis has been accepted for review by the Center for Drug Evaluation (CDE) of the NMPA, noted the firm.
Akeso is currently trading on the Hong Kong Stock Exchange at HK$ 92.65, up 5.52%
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