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news.Hua Medicine announced its third successful clinical trial of lead program HMS5552, a novel glucokinase activator (GKA) treatment for Type 2 diabetes (T2DM). This latest Phase 1c trial demonstrated an impressive 1% HbA1c average reduction in patients compared to their baseline blood levels after only 4 weeks of treatment.
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In addition to the high efficacy, the results showed an excellent tolerability and safety profile with low risk of hypoglycemia or other side effects (such as gastrointestinal discomfort) common in many diabetes treatments.
"HbA1c levels indicate the average level of glucose in a person’s blood over time. Hence HbA1c is measurably higher in diabetic patients vs. normal levels. Usually, it takes more than 12-16 weeks to see a noticeable effect from a new diabetes therapy, since this is the average life span of the red blood cells that carry HbA1c," explained Dr. Li Chen, CEO of Hua Medicine.
"Discerning a greater than 1% reduction in HbA1c after only 4 weeks means HMS5552 is highly efficacious, especially in this typical diabetic population (baseline HbA1c of 8.9%).
"Additionally, the data indicate improvement in ß-cell function via significantly increased HOMA-ß and decreased HOMA-IR parameters compared to baseline. Overall, we expect to further expand on these promising results during our longer 12-week Phase 2 trial, currently underway."
"As was seen in previous Phase 1a and Phase 1b trials, HMS5552 again showed sustained 24-hour glucose control of both fasting plasma glucose (FPG) and post-meal glucose (PMG)," added Dr. Yi Zhang, Hua Medicine’s Head of Clinical Development.
"Furthermore, these outstanding efficacy and safety results remained consistent throughout the month-long treatment period in both the once-a-day and twice-a-day patient dosing groups tested in this Phase 1c study. This indicates HMS5552 has the potential to be a convenient and effective once-a-day oral therapy."
The previous Phase 1a clinical data were presented at the 74thAmerican Diabetes Association (ADA) Conference in San Francisco in June 2014, while the Phase 1b clinical data were recently presented at the 75thADA Conference in Boston in June 2015.
The data from both trials along with the Phase 1c results will shortly be submitted to an international scientific journal for review and publication.
This Phase 1c study was a single-center, randomized, open-label, parallel 2-dose arm study in 24 diabetic patients comparing 75mg once-a-day vs. 75mg twice-a-day treatment of HMS5552 over a 4 week dosing period.
The study was designed to assess the safety, tolerability, PK/PD, ß-cell function and preliminary efficacy of the drug as measured by HbA1c levels and 24-hour FPG / PMG compared to baseline.
"We are gratified with the excellent safety and efficacy results to date. Previous generations of GKA compounds developed by others have encountered a number of clinical issues related to hypoglycemia, triglyceride elevations, and efficacy loss in the first several weeks of use. None of these issues were seen in HMS5552, a 4th-generation GKA, either in this 4-week trial or any prior clinical or pre-clinical studies," observed Dr. John Baldwin, Hua Medicine’s Scientific Advisory Board Chairman.
"Many of the previous generation issues were likely related to specific chemical structural features rather than mechanism. For example, two unsuccessful compounds that suffered from similar clinical issues share an identical tri-benzenoid scaffold. In comparison, HMS5552 has an entirely different, amino-acid-based scaffold which seems to have made a significant difference in overcoming these clinical hurdles."