Bayer and Hua Medicine, a leading innovative drug development company, have announced a commercialization agreement and strategic partnership for dorzagliatin, a novel diabetes treatment, in China.
SHANGHAI, CHINA, July 1, 2020 - (ACN Newswire) - Hua Medicine today announced the positive 24-week top-line results from HMM0302, a Phase III registration trial in China of its global first-in-class glucokinase activator dorzagliatin add-on to metformin, a first line oral antidiabetic therapy in Type 2 diabetes. All subjects are treated with metformin (Glucophage) at 1500mg/day as basic therapy throughout the entire 52-week treatment period. These patients are also given either twice-daily doses of dorzagliatin (75mg) or placebo, randomized on a 1:1 ratio. The clinical study evaluates the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period when all patients will receive dorzagliatin 75mg twice daily. The primary efficacy endpoint is evaluated at the conclusion of the first 24 weeks. The subsequent 28-week treatment period is ongoing.
HMM0112 is a Phase I trial conducted in the United States in Type 2 Diabetes (T2D) patients with insufficiently controlled blood glucose levels while on metformin, DPP-4 inhibitors or SGLT-2 inhibitors, alone or in combination treatment. The principal purpose of HMM0112 is to investigate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of dorzagliatin and empagliflozin (a SGLT-2 inhibitor) as either monotherapy or combination therapy. The PK results demonstrated no impact of dorzagliatin (75 mg BID) and empagliflozin (25 mg QD) on their respective PK properties under co-administration, supporting their combination use in the clinical setting, while the PD results demonstrated a clear synergistic effect in efficacy under combination therapy. Following OGTT, the combination treatment achieved significantly enhanced glucose lowering effect (AUEC: 279 h•mg/dL) over empagliflozin (AUEC: 452 h•mg/dL, P<0.01) or dorzagliatin (AUEC: 364 h•mg/dL, P<0.05) monotherapy. Moreover, significantly increased C-peptide secretion was also observed for the combination treatment over empagliflozin monotherapy. These results support the development of a combination therapy of dorzagliatin with empagliflozin, which will provide improved benefits and better solutions to T2D patients.
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.
Shanghai-based diabetes drugmaker Hua Medicine has concluded its Hong Kong IPO with a $110.5 million (HK$867 million) raise by pricing at the low end of its range. Now valued at $1.1 billion, Hua was the second company to take advantage of the city’s new rules allowing pre-revenue biotechs to list on it stock exchange.