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Uni-Bio Science Group Announces Positive Phase III Results for Uni-E4 in Type-2 Diabetes
- Uni-E4, a twice-daily administered GLP-1 (Glucagon-like peptide-1) receptor agonist, successfully meets primary endpoint in Type-2 diabetes study
- Uni-E4 confirmed as safe and efficacious for Type-2 diabetes
- Uni-E4 demonstrated significant difference in change of body weight versus insulin glargine
- Uni-E4 generally well-tolerated with no significant adverse events
HONG KONG, Aug 03, 2015 - (ACN Newswire) - Uni-Bio Science Group Limited ("Uni-Bio" or the "Group";HKEx code: 690) today announced positive top-line results of the Phase III clinical trial which assessed the efficacy and safety of Uni-E4, Uni-Bio's proprietary recombinant GLP-1 receptor agonist for the treatment of Type-2 diabetes. Results from the study showed that Uni-E4, a twice-daily administered GLP-1 receptor agonist, achieved its primary endpoint of reduction of HbA1C levels after 24 weeks of treatment, indicating its efficacy in lowering blood glucose as non-inferior to insulin glargine.
The 24-week study enrolled a total of 471 Type 2 diabetes patients who were not well-managed by metformin and/or sulfonylurea treatment, and were randomly selected at a 3:1 ratio to receive either Uni-E4 (treatment group, n=355) or insulin glargine (control group, n=116). HbA1c levels were reduced by 1.02% in patients taking Uni-E4, versus a reduction of 0.93% in those taking insulin glargine. The Uni-E4 patients reported a reduction in body weight of 0.70kg, whereas insulin glargine patients increased body weight by 0.74kg, the difference in weight change was statistically significant. Uni-E4 also demonstrated a statistically significant difference in the rate of hypoglycemic reactions (1.44%) compared to insulin glargine (5.22%). Uni-E4 was generally well-tolerated with adverse events consistent with the data reported in literature relating to the GLP-1 class.
China has the largest number of people with diabetes in the world by country, national diabetes prevalence currently stands at over 100 million (approximately 8% of the population) and it is estimated that more than 50 million patients are undiagnosed, spurring the growth of the overall diabetes pharmaceutical market in China to $3.2 billion in 2016 . Mortality attributable to diabetes in China is amongst one of the leading and fastest growing causes of death, according to the World Health Organisation, and reached almost 15.8% in the Western Pacific, making it one of the most deadly diseases in the region . If current trends continue, it is expected that 143 million people in China will have diabetes by 2035, placing a tremendous financial and human burden on healthcare resources and emphasizing the need for new treatment options to manage the long-term, chronic condition.
Uni-E4 effectively regulates blood glucose level through multiple mechanisms including stimulating insulin secretion, inhibiting glucagon release, decreasing appetite and decreasing gastric emptying. As a member of the GLP-1 agonist class, it is positioned as a major second-line treatment option. It is well understood that obesity is an important factor that can lead to insulin resistance in diabetes patients and many antidiabetic drugs, including insulin, can contribute to increased body weight of diabetes patients, making further treatment even more difficult. This is a particularly important issue in China where 30% of Chinese Type-2 diabetes patients are already overweight. The results from the Uni-E4 trial demonstrate that, when compared to insulin glargine, Uni-E4 can effectively decrease the body weight of diabetes patients through suppressing the appetite and prolonging gastrointestinal emptying time. Furthermore, Uni-E4 has also been shown to lower the risk of hypoglycemia, an important clinical advantage in managing T2D complications in the long term.
Uni-Bio is currently finalizing the clinical trial summary report and plans to submit a New Drug Application for Uni-E4 to the China Food and Drug Administration in early 2016.
Mr. Kingsley Leung, Executive Director of Uni-Bio Science Group, said: "We are delighted to announce the positive results of the Uni-E4 Phase III clinical trial. The results are a significant achievement for Uni-Bio and our highly-skilled research and development teams. There is a great unmet need in the provision of new therapeutics for the growing burden of diabetes in China, a chronic condition that can lead to serious and costly long-term complications as well as rising mortality rates, and we are proud to be making important clinical advances to address this."
"Uni-Bio was one of the first companies to focus on recombinant technology in China and is on track to be the first domestic company in the region to launch an important new GLP-1 treatment for diabetes. The soaring numbers of patients diagnosed with diabetes in China presents an important commercial opportunity for Uni-Bio and we are well positioned to capture this. We look forward to filing the NDA with the CFDA early next year and to continue to make significant progress on our commitment to identify new treatment options for patients with Type-2 diabetes in China."
About Type-2 diabetes
Type 2 diabetes mellitus (T2D) is a clinical syndrome, characterized by hyperglycemia, affecting more than 100 million people in China. It is estimated that China's diabetes treatment market will expand 20% annually to reach $3.2B by 2016, becoming one of the largest therapeutic areas in the PRC. According to the International Diabetes Federation, China has the world's largest diabetes epidemic, and it continues to grow rapidly. With rising prevalence and an aging population, there is a great demand for newer, safer and more cost effective T2D therapeutics.
Contact:Strategic Financial Relations Limited
Veron Ng Phone: +852 2864 4831 Email: veron.ng@sprg.com.hk
Angelus Lau Phone: +852 2864 4805 Email: angelus.lau@sprg.com.hk
Caley Chan Phone: +852 2114 4950 Email: caley.chan@sprg.com.hk
Fax: +852 2527 1196
Source: Uni-Bio Science Group Limited
Sectors: Daily Finance, Healthcare & Pharm
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