Bioalpha Holdings obtains NPRA approval to carry out human clinical trials for botanical-based type II diabetes

KUALA LUMPUR: Bioalpha Holdings Bhd has received approval from the National Pharmaceutical Regulatory Agency (NPRA) to begin human clinical trials in Malaysia utilising a botanical medicine to treat type II diabetes.

The integrated health supplement company would undertake the clinical trial in collaboration with an internationally accredited Contract Research Organisation, expected to take place at a Malaysian general hospital.

The trial's objective is to ascertain the ideal dosage for humans and evaluate how the human body reacts to the drug.

Managing director William Hon said the company had made good progress in developing its type II 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," he said.

Hon said 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.

During the earlier pre-clinical trials, the drug yielded no undesirable side effects, and the company look forward to this being the case in humans as well.

"We have been working on our botanical drug since 2011, and it has undergone pre-clinical trials in Taiwan and India with promising results. Bioalpha has been using the findings and results obtained during the progress of the pre-clinical trials thus far to create health supplement products.

"We shall continue to do so during the entire duration of the human clinical trials for us to manufacture highly effective and efficient products."

"We have obtained a total of nine patents in Malaysia and Taiwan, including the use of a composition of active ingredients of Andrographic Paniculata in liver and kidney protection, as well as in treating hyperlipidemia, among others."

He said Bioalpha aimed to be the pioneer to utilise Malaysian herbal plants to treat type II diabetes and is hopeful 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.

"There are altogether three phases of human clinical trials to determine the optimal dose level, efficacy and safety in humans.

"Once the drug completes all three phases of clinical trials, we will submit all necessary documentation to the Drug Control Authority (DCA) to seek approval for commercialisation to the masses," added William.

Bioalpha said there is vast potential commercialisation potential to be reaped, citing research conducted by GlobalData, the global type II diabetes market was likely to reach US$58.7 billion by 2025.

Meanwhile, the International Diabetes Foundation projected that the number of diabetes cases in Asia would increase to more than 320 million in the next ten years.

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