Hua Medicine hopes to initiate the Phase I trial of once-daily Huatangning by the end of H1 2024. Image credit: Green Apple / Shutterstock.

China-based Hua Medicine plans to focus on the US trial development of its type 2 diabetes (T2D) drug in diabetic kidney patients.

Chief strategy officer George Lin told Clinical Trials Arena that the company is looking to develop a once-daily version of its drug Huatangning (dorzagliatin) in the US.

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The company filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the second generation of HuaTangNing after previously holding four Phase I trials in the US of the twice-daily version of the candidate which is marketed in China in partnership with Bayer.

The Phase I trial will be a safety trial lasting two weeks with no more than 20 participants enrolled across a maximum of three sites in the US. The trial will enrol both healthy volunteers and T2D patients.

Hua Medicine will also evaluate the key secondary endpoints of pharmacokinetics and pharmacodynamics in the Phase I trial.

Lin adds that the first patient in the trial will be dosed by the end of H1 2024 with data expected by the end of H2 2024.

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If successful, Lin says that Hua Medicine plans to run a Phase II trial of the candidate in diabetic patients with kidney disease with the hope of getting FDA approval in that indication before conducting further trials to broaden the label to T2D specifically.

HuaTangNing is an oral glucokinase activator (GKA), a key regulator of glucose homeostasis. GK modulates blood glucose by inducing glucose-stimulated insulin release in the pancreas and by inducing glycogen formation and glucose breakdown in the liver.

Hua Medicine CEO Li Chen PhD brought dorzagliatin from original developer Roche where he had worked for 18 years.

T2D landscape

According to GlobalData, the T2D market is set to shift with glucagon-like peptide 1 receptor agonists (GLP-1RA’s) to surpass PD1 Antagonists as the best-selling drugs in 2024 and beyond.

The main GLP1-RA’s set to dominate the market are Ozempic/Wegovy, Mounjaro, Cagrisema, and Rybelsus, which are forecast to capture 83% of the GLP-1RA market by 2029.

Despite Eli Lilly’s Mounjaro being predicted to lead in sales, Novo Nordisk is expected to emerge as the leading company, holding a predicted 55% of the market share in 2029.

GlobalData forecasts the T2D market to be worth $91.6bn in 2030.

GlobalData is the parent company of Clinical Trials Arena.