HONG KONG, CHINA - EQS Newswire - 18 September 2020 - The board of directors (the "Board") of Uni-Bio Science Group Limited (the "Company", together with its subsidiaries, the "Group") is pleased to announce updates on the developmental potential of the Group's innovative biologic self-developed drug Recombinant Exendin-4 Injection ("Uni-GLP").
Uni-GLP, a class of glucagon-like peptide-1 receptor agonists ("GLP-1 RAs"), can reduce high blood glucose by increasing insulin and decreasing glucagon secretion, is effective in the treatment of Type 2 diabetes mellitus ("T2DM"). GLP-1 RAs are particularly advantageous because of their incretin effect which can lower risk of hypoglycemia. In addition, GLP-1 RAs is one of the only classes of diabetic drugs shown to cause significant weight loss. The application for clinical trial of Uni-GLP submitted by the Company has been accepted by National Medical Products Administration ("NMPA") on 14 July 2020. Currently, the Group's professional and technical personnel are making great efforts to prepare for clinical trial-related works.
New Progress and Opportunities of GLP-1 RAs
Based on new data presented in the scientific community, GLP-1 RAs can treat a wide range of high value indications such as obesity, cardiovascular disease ("CVD"), nonalcoholic fatty liver disease ("NAFLD") and nonalcoholic steatohepatitis ("NASH"), Alzheimer's disease ("AD"), as well as new coronavirus disease 2019 ("COVID-19"; caused by severe acute respiratory syndrome coronavirus 2, "SARS-CoV-2"), where there are significant unmet medical needs.
As obesity is a common comorbidity of T2DM, this class is effective in T2DM patients who are overweight, accounting for at least 30% of all diabetes patients in the PRC according to IMS primary research. In addition, GLP-1 RAs has further been shown to have beneficial impact on cardiovascular function independent of its role in peripheral glycemic control, through increasing myocardial glucose uptake, preserving myocardial function following ischemic injury. Moreover, evidence suggests that GLP-1 secretion is impaired in patients with NAFLD and NASH-the aggressive form of NAFLD that can lead to cirrhosis and hepatocellular carcinoma, highlighting the role of GLP-1 RAs as potential candidates for NAFLD treatment. Furthermore, emerging evidences have shown that AD, caused by "starvation" of the brain, is associated with insulin resistance. When the brain cannot use glucose due to insulin resistance, it can lead to inflammation and deposition of plaques and tangles. Nevertheless, GLP-1 RAs can prevent the decline of brain glucose consumption, causing synaptogenesis and neurogenesis, thereby improving memory behavior.
Most recently, it has been hypothesized that GLP-1 RAs have been considered excellent candidates for the treatment of patients with COVID-19 with or without T2DM owing to their multiple beneficial effects on excessive inflammation-induced acute lung injury. Multiple preclinical studies performed in mice and rats with experimental induced lung injury demonstrated that GLP-1 RAs attenuate pulmonary inflammation, through inhibitory activity on cytokine release, as a result of their interference with nuclear factor-κB ("NF-κB") signaling pathways. More recently, several studies have demonstrated the capacity of GLP-1 RAs to enhance the activity of the angiotensin converting enzyme 2 ("ACE2")→ angiotensin (1--7)（"A(1--7)"）→Mas receptor ("MasR") axis by directly stimulating ACE2 expression would contribute to reduce the progression of inflammatory and thrombotic processes frequently associated with the poor prognosis of SARS-CoV-2 infection, through the fostering of an antithrombotic and anti-inflammatory milieu. Lung injury and inflammation is seen in more severe COVID-19 infected patients, and a leading cause of COVID-19 related fatalities. The advantage compared with vaccine is that the GLP-1 RAs can continue to protect lung function even when coronavirus mutates.
Next Steps for Uni-GLP
The Board is optimistic about Uni-GLP's potential in new therapeutic areas. The Group has already kicked off partnerships with several universities in PRC to conduct preclinical research of Uni-GLP in obesity, as well as to formulate a new innovative oral or 3rd generation Uni-GLP. Armed with the recent data of GLP-1 RA in treatment of CVD, NAFLD, NASH, AD and COVID-19, the Group is currently in talks with NMPA and prospective partners to expand Uni-GLP into these new areas.