Hua Medicine’s big diabetes bet pays off in key Phase 3 win
Two years ago, Hua Medicine turned to the public markets to help finance its ambitious diabetes program. “Our future success depends substantially on the success in China of our only clinical drug candidate, dorzagliatin,” the Shanghai-based pharma said in its IPO filing.
The company kept plugging away at the effort quietly until last week, when it announced the completion of its first Phase 3 trial. A positive readout sent the stock soaring 27% — and could make Hua the first company globally to win approval for a novel diabetes therapy known as a glucokinase activator, a class also being developed in the United States, India, and Japan.
In Hua’s yearlong Phase 3 trial, 463 patients with type 2 diabetes who had received no prior treatment were randomized to receive a double-blinded, 24-week treatment of either dorzagliatin or placebo. At the end of this period, all patients then continued the trial in an open-label format, receiving a 28-week treatment period of the orally administered dorzagliatin.
Patients who received dorzagliatin at the start of the trial saw their levels of HbA1c, a measure of blood glucose levels, drop by an average of 1.15%, a statistically significant measure. Patients who started on placebo saw their levels reduced by an average of 1.27%.
Hua is expected to file for approval for dorzagliatin with China’s National Medical Products Administration. A separate Phase 3 trial pairing dorzagliatin with metformin, the standard first-line therapy, is ongoing. It is expected to be completed by the end of this year.
Read more.
The company kept plugging away at the effort quietly until last week, when it announced the completion of its first Phase 3 trial. A positive readout sent the stock soaring 27% — and could make Hua the first company globally to win approval for a novel diabetes therapy known as a glucokinase activator, a class also being developed in the United States, India, and Japan.
In Hua’s yearlong Phase 3 trial, 463 patients with type 2 diabetes who had received no prior treatment were randomized to receive a double-blinded, 24-week treatment of either dorzagliatin or placebo. At the end of this period, all patients then continued the trial in an open-label format, receiving a 28-week treatment period of the orally administered dorzagliatin.
Patients who received dorzagliatin at the start of the trial saw their levels of HbA1c, a measure of blood glucose levels, drop by an average of 1.15%, a statistically significant measure. Patients who started on placebo saw their levels reduced by an average of 1.27%.
Hua is expected to file for approval for dorzagliatin with China’s National Medical Products Administration. A separate Phase 3 trial pairing dorzagliatin with metformin, the standard first-line therapy, is ongoing. It is expected to be completed by the end of this year.
Read more.
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