HK-based Chi-Med wraps up PhI healthy volunteer trial of HMPL 523

Hong Kong-based Hutchison China MediTech (Chi-Med) said its research subsidiary Hutchison MediPharma has wrapped up its first human Phase I clinical trial of HMPL 523, which is a small molecule inhibitor targeting spleen tyrosine kinase.

The Phase I study was a "dose-escalating study to assess the safety, tolerability and pharmacokinetics of both single and repeat doses of HMPL 523 in healthy volunteers in Australia," the company said in a release.

The company said in its statement that the "preliminary safety profile of HMPL 523 was in-line with our expectations" and "no material off-target toxicities such as hypertension and severe diarrhea were observed with HMPL 523 in this study. Furthermore, HMPL 523 exhibited a linear pharmacokinetic profile and a dose dependent suppression of B-cell activation."

Chi-Med CEO Christian Hogg

"We have now established what we believe is a dose range for the further development of HMPL 523," Chi-Med CEO Christian Hogg said in the press release. "This will now allow Chi-Med to move this important, potentially first-in-class compound into global Phase II proof-of-concept studies against multiple indications both in autoimmune diseases and oncology."

Chi-Med also said it would present preclinical results on its compounds sulfatinib and its fruquintinib-savolitinib combination at the 2015 International Conference on Molecular Targets and Cancer Therapeutics in Boston, to be held Nov. 5 through Nov. 9.

The drugs are being reviewed in clinical trials for treating various cancers.

"Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth," the company said in its release.

HMP said it will present results from its Phase I trial in China, "focusing on neuroendocrine tumour ('NET') patients."

"In this study, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4% and disease control rate was 100%," the company said, adding "by comparison, sunitinib and everolimus, the two approved single agent therapies for neuroendocrine tumours, achieve objective response rates of less than 10% in their pivotal clinical trials. Furthermore, neuroendocrine tumour responses to sulfatinib have been observed to improve gradually with time."

The company said the results showed sulfatinib "was well tolerated with an acceptable safety profile" and also said "promising anti-tumour activity was observed in NET patients."

- here's the release on the trial
- and the release on the upcoming presentation