Bioalpha Holdings Berhad has obtained approval from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) to commence human clinical trial in Malaysia for the botanical drug in relation to treatment of type 2 diabetes.
Bioalpha will undertake the clinical trial in collaboration with an internationally accredited Contract Research Organisation, expected to take place at a Malaysian general hospital.
The objective of the trial is to ascertain the ideal dosage for humans and evaluate the human body reaction to the drug.
We are delighted to have made good progress on the development of our type 2 diabetes botanical drug. The advancement from pre-clinical to clinical trial is a testament of our hard work and commitment to the eventual commercialisation of our botanical drug. With this NPRA approval, Bioalpha is one step closer to bringing a safe and efficacious herbal treatment for type 2 diabetes to the market,” said Mr. William Hon, Managing Director of Bioalpha.
“The drug, which contains herbs such as Hempedu Bumi or scientifically known as Andrographic Paniculata, has shown to lower and stabilise the patient’s average blood glucose levels or better known as HbA1c, while protecting the liver and kidney, in addition to reducing the blood lipid profile. Another important note is that during the earlier pre-clinical trials, the drug yielded no undesirable side-effects and we look forward to this being the case in humans as well,” Mr. Hon added.
“We have obtained a total of 9 patents in Malaysia and Taiwan, including the use of composition of active ingredients of Andrographic Paniculata in liver and kidney protection, as well as in treating hyperlipidemia, among others. Bioalpha aims to be the pioneer to utilize Malaysian herbal plants to treat type 2 diabetes, and hope to be the first to roll out a botanical drug product in our country. With our formulation now entering human clinical trials, we are certainly moving in the right direction.”
“There are altogether 3 phases of human clinical trials to determine the optimal dose level, efficacy and safety in humans. Once the drug successfully completes all 3 phases of clinical trials, we will submit all necessary documentations to the Drug Control Authority (“DCA”), to seek approval for commercialisation to the masses.” Mr.Hon concluded.
