HONG KONG – Calling success in the first proof-of-concept trial for its cancer drug, fruquintinib, Hong Kong-based Hutchison Medipharma said the drug achieved primary efficacy endpoints. Phase III trials will now start for the colorectal indication of fruquintinib, even as development continues in two other indications.

"One down, two to go. It is a very positive step. We have already started the phase III for colorectal cancer," said Christian Hogg, CEO of Hutchison China Meditech Ltd., also known as Chi-Med, the parent firm of Hutchison Medipharma, which is focused on R&D and drug discovery.

"It is important because it is the first proof of concept for fruquintinib," he added. "We currently have development ongoing in colorectal cancer, in lung and in gastric. Lung and gastric will read out later this year.

"Fruquintinib is a really high-quality drug candidate and we are all very enthusiastic about it," Hogg said.

A phase III study is enrolling "rapidly" and could conclude later this year or early in 2016. "If it is successful we hope to be submitting next year some time," Hogg told BioWorld Today.

The plan is to get the drug to market in China first but "subject to the quality of the phase II proof-of-concept clinical trial results we will consider going beyond China."

Hogg said the results of the proof-of-concept trial for fruquintinib were positive and its development will continue apace. The drug achieved primary endpoint of progression-free survival in the Chinese trial enrolling patients with metastatic colorectal cancer (mCRC), Chi-Med said.

Hutchison is continuing with assessments of secondary efficacy endpoints, which include the objective response and disease control rates as well as overall survival rates. All three were in line with expectations at the end of the last six-month data cut-off in February. The company said there were no unexpected safety issues or adverse effects but has not yet released full details from the trial.

The aim of the proof-of-concept phase II study was to compare the efficacy and safety of fruquintinib plus the best supportive care – usually chemotherapy – against a placebo plus best supportive care in patients with mCRC.

The trial that started last April completed enrollment in August 2014. It involved 71 patients and was a randomized, double-blind, placebo-controlled study that enrolled subjects who had failed at least two prior chemotherapies such as fluoropyrimidine, oxaliplatin and irinotecan. Two patients received fruquintinib for every one that received placebo.

Chi-Med is now looking to get results from ongoing proof-of-concept studies in lung cancer around the middle of this year and in gastric cancer some time after that.

The gastric cancer study is testing fruquintinib in combination with chemotherapy, and the company is undertaking a phase Ib dose-finding study that could be completed shortly, certainly before the middle of 2015. The plan then is to kick off a full phase II proof-of-concept study in second-line gastric cancer in the later half of the year.

Hutchison Medipharma is a China-based drug development company. It is currently developing 16 drugs and has partnerships with Astrazeneca plc, Johnson & Johnson unit Janssen, Eli Lilly and Co. and Nestle as well as 18 universities and hospitals.

Hutchison Medipharma's s pipeline includes 10 advanced drug candidates, including fruquintinib; HMPL-004 for ulcerative colitis and Crohn's disease; sulfatinib for neuroendocrine tumors; eptitinib for non-small-cell lung cancer (NSCLC); theliatinib for osoephageal and solid tumors, savolitinib for NSCLC and gastric cancer as well as papillary renal carninoma; HMPL-523 for rheumatoid arthritis, multiple sclerosis, lupus and hematological cancers; HMPL-689 for hematological cancers; and HMPL-453 for solid tumors. Trials are under way in China, the U,S,, the EU and Australia.

The company was founded in 2002 with funding from Hutchison Whampoa, a Hong Kong conglomerate controlled by tycoon Li Ka-shing. Its original goal was to search for botanical drugs. The company filed its first investigational new drug application for HMPL-004 with the FDA in 2005 and went public on London's Alternative Investment Market in 2006.