sovleplenib (HMPL-523)

P1, N=134, Completed, Hutchison Medipharma Limited | Unknown status --> Completed | N=217 --> 134

P2/3, N=110, Recruiting, Hutchison Medipharma Limited | Active, not recruiting --> Recruiting

P1, N=45, Completed, Hutchison Medipharma Limited | Unknown status --> Completed

P1, N=6, Completed, Hutchmed | Active, not recruiting --> Completed | N=10 --> 6

P3, N=272, Active, not recruiting, Hutchison Medipharma Limited | N=188 --> 272 | Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Dec 2023 --> Oct 2024

Sovleplenib showed a clinically meaningful sustained platelet response in patients with chronic primary immune thrombocytopenia, with a tolerable safety profile and improvement in quality of life. Sovleplenib could be a potential treatment option for patients with immune thrombocytopenia who received one or more previous therapy.

Sovleplenib is a potent and selective Syk inhibitor with favorable preclinical PK profiles and robust anti-inflammation efficacy in a preclinical collagen-induced arthritis model. Sovleplenib is now being developed for treating autoimmune diseases such as immune thrombocytopenic purpura and warm antibody hemolytic anemia as well as hematological malignancies.

P1, N=48, Recruiting, Hutchmed | Not yet recruiting --> Recruiting

P1, N=48, Not yet recruiting, Hutchmed

P1, N=140, Active, not recruiting, Hutchmed | Recruiting --> Active, not recruiting

Sovleplenib showed antitumor activity in relapsed/refractory B-cell lymphoma with acceptable safety. Further studies are warranted.

Inhibition of Syk could provide a novel therapeutic approach for autoimmune diseases and hematologic malignancies. The manuscript describes the preclinical pharmacology characterization of sovleplenib, a novel Syk inhibitor, in enzymatic and cellular assays in vitro and several murine autoimmune disease models in vivo.

The dose expansion phase of the study will evaluate safety and efficacy in patients with multiple subtypes of B-cell and T-cell lymphoma at the RP2D of 700 mg. Updated safety, PK, and anti-tumor activity will be presented.

Ongoing global studies are still open and enrolling patients with R/R lymphoma. Validated data / results from this study will be made available at the end of dose escalation and or at the conclusion of dose expansion stage.