LONDON, UK I August 23, 2019 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase (“Syk”) inhibitor, in patients with immune thrombocytopenia (“ITP”), an autoimmune disorder that can lead to increased risk of bleeding. The first ITP patient was dosed on August 12, 2019 in China.
The study is a randomized, double-blinded, placebo-controlled Phase Ib clinical trial investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-523 in adult patients with ITP. The primary endpoint is the number of patients with any adverse event. The secondary endpoints are maximum plasma concentration (Cmax), area under the concentration-time curve in a selected time interval (AUC0-t), and rate of clinical remission at week 8. The trial is comprised of a dose escalation stage and a dose expansion stage. Approximately 50 to 60 patients will be enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT03951623.
This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifiers: NCT02857998 and NCT03483948) addressing a broad range of hematological cancers. These cancers include acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom’s macroglobulinemia. Preliminary results of the dose escalation stage in a Phase I study in China of HMPL-523 in patients with relapsed or refractory B-cell lymphomas were presented in 2018.1 A Phase I dose escalation study in Australia in healthy volunteers was also completed, showing that HMPL-523 was generally well tolerated (clinicaltrials.gov identifier: NCT02105129).
About HMPL-523
HMPL-523 is a novel, highly selective and potent small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established therapeutic target in multiple subtypes of B-cell lymphomas and autoimmune disorders.
About ITP
ITP is a type of thrombocytopenic defined as isolated low platelet count (thrombocytopenia) with normal bone marrow and the absence of other causes of thrombocytopenia. Patients with ITP exhibit symptoms of petechiae, purpura, and gastrointestinal and/or urinary mucosal tract bleeding.2 ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life, across domains of emotional, functional and reproductive health, and work or social life.3-7 The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults.8
Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem. Many patients develop resistance to treatment and thereby are prone to relapse.9 Thus, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of a new approach to treatment.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 186
LONDON, UK I August 23, 2019 I Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase (“Syk”) inhibitor, in patients with immune thrombocytopenia (“ITP”), an autoimmune disorder that can lead to increased risk of bleeding. The first ITP patient was dosed on August 12, 2019 in China.
The study is a randomized, double-blinded, placebo-controlled Phase Ib clinical trial investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-523 in adult patients with ITP. The primary endpoint is the number of patients with any adverse event. The secondary endpoints are maximum plasma concentration (Cmax), area under the concentration-time curve in a selected time interval (AUC0-t), and rate of clinical remission at week 8. The trial is comprised of a dose escalation stage and a dose expansion stage. Approximately 50 to 60 patients will be enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT03951623.
This study complements the ongoing Phase Ib dose expansion program of HMPL-523 in Australia (clinicaltrials.gov identifier: NCT02503033) and China (clinicaltrials.gov identifiers: NCT02857998 and NCT03483948) addressing a broad range of hematological cancers. These cancers include acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma and Waldenstrom’s macroglobulinemia. Preliminary results of the dose escalation stage in a Phase I study in China of HMPL-523 in patients with relapsed or refractory B-cell lymphomas were presented in 2018.1 A Phase I dose escalation study in Australia in healthy volunteers was also completed, showing that HMPL-523 was generally well tolerated (clinicaltrials.gov identifier: NCT02105129).
About HMPL-523
HMPL-523 is a novel, highly selective and potent small molecule inhibitor for oral administration targeting spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor signaling and is an established therapeutic target in multiple subtypes of B-cell lymphomas and autoimmune disorders.
About ITP
ITP is a type of thrombocytopenic defined as isolated low platelet count (thrombocytopenia) with normal bone marrow and the absence of other causes of thrombocytopenia. Patients with ITP exhibit symptoms of petechiae, purpura, and gastrointestinal and/or urinary mucosal tract bleeding.2 ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life, across domains of emotional, functional and reproductive health, and work or social life.3-7 The incidence of primary ITP in adults is 3.3/100,000 adults per year with a prevalence of 9.5 per 100,000 adults.8
Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem. Many patients develop resistance to treatment and thereby are prone to relapse.9 Thus, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of a new approach to treatment.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapeutics and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
SOURCE: Chi-Med
Post Views: 186
