TAIPEI, July 10, 2020 /PRNewswire/ -- Center Laboratories Inc. (CenterLab: 4123.TWO), a pharmaceutical company dedicated in specialty drug product development, announced today that the anti-diabetic drug – CS02 meets its primary endpoint. The topline results of a phase 2 clinical trial of CS02 showed significantly decreases of glycated hemoglobin (HbA1c) in treated patients as compared to placebo group by 0.45% (p value = 0.0098).
CS02 is an orally administered small molecule drug under development following the abbreviated 505(b)(2) regulatory pathway for new drug approval. This phase 2 trial is a proof of concept (PoC) study according to the US FDA's guidance to explore its glycemic controlling effect primarily. Furthermore, CenterLab included Homeostasis model2 assessment β-cell (HOMA2-β) as a secondary endpoint demonstrating its capability in beta cell preservation. The results from the Phase 2 trial showed that CS02 significantly decreased HbA1c and had stellar performance on preserving pancreatic beta cell function with HOMA2-β increased by 13.45%.
According to American Diabetes Association (ADA), cardiovascular disease (CVD) is the major cause of morbidity and mortality for diabetic patients and results in $37.3 billion in related expenditure per year. As CS02 was designed to be submitted through 505(b)(2) pathway to treat diabetes with new mechanism, not only could CS02 reduce blood glucose level, but it could also reduce the risk of cardiovascular complications by reducing blood pressure as its inherent feature. Through 505(b)(2) pathway, the safety, tolerability and pharmacokinetic profiles from previously approved drug and published references can be leveraged to support the safety and/or effectiveness of CS02, by that, redundant investigation processes could be waived and significantly shorten the drug product development time to market.
"CenterLab is highly committed to patients' unmet needs, thus, CenterLab aims to bring on better treatments which is more cost-effective and safer compared to other treatments. We believe CS02, as a potential blockbuster for diabetes treatment, has a role in improving patients' life quality," said Robert Hsu, the GM of CenterLab.
For further development of CS02, CenterLab is actively seeking global partners for co-development or licensing opportunities.
Center Laboratories Inc. is a professional oral liquid pharmaceutical company and experts in worldwide specialty drug development. Also, we bring together resources and experiences to help potential biotechnology and healthcare companies tap into the global market.