ARCH-backed Chinese biotech scores PhIII win for glucokinase-modulating diabetes drug
When ARCH Venture Partners helped launch Hua Medicine with former Roche exec Li Chen, it marked one of the first bets on a Chinese biotech to deliver a world-class diabetes drug. Eight years later, their lead drug appears to have turned the corner and entered the final stretch.
Late on Monday night Shanghai time — where it’s based — Hua unveiled positive data from the first part of its pivotal study of dorzagliatin, celebrating a win on the primary endpoint as well as decent safety results.
“With these 24-week top-line results from HMM0301, Hua Medicine becomes the first China-based biotech company to advance a global first-in-class drug candidate with a well-defined mechanism of action by achieving its primary efficacy endpoint, while also demonstrating a desirable safety profile,” said ARCH managing director Robert Nelsen, who chairs Hua’s board, in a statement.
First licensed from Roche, dorzagliatin is designed to restore glucose homeostasis by modulating glucokinase — an enzyme that typically serves as a glucose sensor.
In the HMM0301 trial involving 463 treatment-naive patients with type 2 diabetes, the drug arm experienced an HbA1c reduction of 1.07% from baseline (8.35%) compared to the average 0.50% reduction seen in the placebo group (baseline 8.37%). The p-value was less than 0.0001.
On a secondary endpoint representing a treatment target defined by the American Diabetes Association, 45.4% of patients on the drug saw their HbA1c dip below 7.0% versus 21.5% on placebo.
Other secondary measures — ranging from 2-hour postprandial plasma glucose and fasting plasma glucose to incidence of treatment-emergent adverse events over time — were not reported.
Importantly for a drug positioned for a massive market, Hua said fewer than 1% of the dorzagliatin group experienced clinically significant hypoglycemia and no severe hypoglycemia was reported.
Following the initial, placebo-controlled 24 weeks, investigators have moved onto a subsequent open-label follow-up period that would last for 28 weeks.
CEO Chen, who ran R&D for Roche for 18 years (7 of them in China) before launching Hua, added that the goal is also to explore combining dorzagliatin with widely prescribed diabetes medicines such as metformin, DPP-4, SGLT2, GLP-1 or insulin depending on patients’ needs.
“Our Phase III trial HMM302 [NCT03141073] targets patients who have failed metformin treatment and has recently completed enrollment. We are launching several clinical studies in the United States and China to investigate the effectiveness of dorzagliatin in different type 2 diabetes patient populations, and new indications in metabolic diseases and cognition,” he said.
Interestingly, Hua’s shares on the Hong Kong stock exchange declined after the announcement, falling 15.88% to HK$5.72 ($0.73) at the end of a local trading day.