Hutchison China MediTech says data from a recent phase I, first-in-human, dose escalating study of the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of HMPL-523, will be presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals in Washington DC.
The presentation will include additional data on HMPL-523, a highly selective, potent and orally available inhibitor of Spleen Tyrosine Kinase.
Syk plays a pivotal role in the regulation of downstream signaling in immune receptors, including B cell receptors (BCRs), which play a key role in autoimmune diseases such as rheumatoid arthritis (RA).
A Phase I dose-escalating study to assess safety, tolerability and PK of HMPL-523 was completed in healthy volunteers in Australia in late 2015. HMPL-523 was administered at up to 800mg as a single dose and up to 400mg in multiple doses in 14 cohorts.
The treatment was generally well tolerated without material off-target toxicities, including lower rates of diarrhea and hypertension compared to what had been observed in first-generation Syk inhibitors.
Furthermore, HMPL-523 demonstrated a dose-dependent suppression of B-cell activation. The Company plans to initiate a Phase II study in the US in 2017.
HMPL-523 is also being studied in oncology indications. A Phase I dose escalation study was initiated in Australia in January 2016 and is expected to complete in the first half of 2017. This study is in patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphoma or chronic lymphocytic leukemia for whom there is no standard therapy.
At 9:21am: (LON:HCM) Hutchison China Meditech Ltd share price was 0p at 1887.5p
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