Bioalpha gets NPRA nod to commence human clinical trials for diabetes botanical drug

TheEdge Mon, Feb 07, 2022 10:08pm - 4 months View Original

KUALA LUMPUR (Feb 7): Bioalpha Holdings Bhd has obtained the approval from the National Pharmaceutical Regulatory Agency (NPRA) to commence human clinical trials in Malaysia for the botanical drug for the treatment of Type 2 diabetes.

The Integrated health supplement company said it will undertake the clinical trials in collaboration with an internationally accredited Contract Research Organisation, which is expected to take place at a Malaysian general hospital.

Bioalpha managing director William Hon said the objective of the trials is to ascertain the ideal dosage for humans and evaluate the human body reaction to the drug.

“The company aims to be the pioneer to utiliseg Malaysian herbal plants to treat Type 2 diabetes, and hopes to be the first to roll out a botanical drug product in the country.

“With our formulation now entering human clinical trials, we are certainly moving in the right direction,” he said in a statement on Monday (Feb 7).

Hon revealed that the drug which contains herbs such as "Hempedu Bumi" or scientifically known as Andrographic Paniculata, has been 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.” 

Hon said Bioalpha has been working on the botanical drug since 2011 and it has undergone pre-clinical trials in Taiwan and India with promising results.

Besides, it has obtained a total of nine patents in Malaysia and Taiwan including the use of the composition of active ingredients of Andrographic Paniculata in liver and kidney protection, as well as in treating hyperlipidemia.

On another note, Hon said there are altogether three phases of human clinical trials to determine the optimal dose level, efficacy and safety in humans.

“Once the drug successfully completes all three phases of clinical trials, we will submit all necessary documentations to the Drug Control Authority to seek approval for commercialisation to the masses,” he added.

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