New Delhi: The Tata group-promoted pharmaceutical company Advinus Therapeutics Pvt. Ltd has successfully completed the first phase of human clinical trials of its indigenous new chemical entity targeting type 2 diabetes. The company is now in talks with big pharma multinationals for out-licensing the molecule for further clinical trials.
The drug candidate, GKM001, was administered to about 40 healthy subjects and the study was then repeated in type 2 diabetics. In this first phase of trials, not only did the drug reduce glucose levels, but it also did not cause hypoglycemia (a condition in which the glucose level drops to a lower than normal level).
“We are very excited about the development. While this particular target has been known for the past 10-15 years, it has failed because it leads to hypoglycemia. In our first phase of human clinical trials, we found no evidence of hypoglycemia even though the drug did reduce glucose levels,” said Rashmi Barbhaiya, chief executive and managing director of Advinus.
According to Barbhaiya, this being a double-blinded placebo study, the study coordinators did not know which subjects had been given the active form of the drug and which had been given the placebo. “However, since we were monitoring sugar levels, we saw significantly low glucose levels in some subjects, while in some it was high and just by looking at these levels we could tell which subjects had been given the active drug,” he said.
While the data for its single-dose phase I trial has been submitted to the Indian drugs regulator, the company is in the midst of conducting a multi-dose study as well. Because the study is being done on diabetics in the first phase itself, the company will now be able to directly go to phase II (b) and will have a better understanding of dosage.
Advinus, which was started five years ago, like most other Indian pharma research firms, will not be taking the molecule to further stages of development on its own due to the investment this would demand and the subject size a clinical trial for a diabetes drug needs.
“We have received request for dialogue from many companies. These companies are among the top five and among the top 20, and are based in the US, Europe and Japan. The benchmark for the size of the deal has already been set by an out-licensing deal that was recently signed between US-based Forest Laboratories Inc. and TransTech Pharma Inc. for a similar drug candidate,” said Barbhaiya.
The Forest-TransTech deal is valued at $1.11 billion (Rs5,173 crore today) in upfront and milestone payments for the successful development and commercialization of a TransTech compound that has been in-licensed by Forest for further development. TransTech received an upfront payment of $50 million, which is more than the amount that Advinus has invested in bringing its compound to the current phase of clinical development.
Advinus expects to close the out-licensing deal in the next three-six months.
However, Advinus is not the first Indian company to have developed a diabetes compound and out-licensed it. Dr Reddy’s Laboratories Ltd (DRL) out-licensed its diabetes drug candidate Balaglitazone to Danish company Rheoscience A/S, and Glenmark Pharmaceuticals Ltd’s candidate Melogliptin was out-licensed to Germany’s Merck KGaA. While DRL’s compound belongs to a category of “glitazones”, which have been the subject of significant debate in the scientific community, Glenmark’s compound was returned after Merck decided to drop diabetes projects from its research portfolio.
This is probably why Barbhaiya is not willing to take any chances. With two decades of work experience in innovator firm Bristol-Meyers Squibb, he, along with Advinus co-founder Kasim Mookhtiar, is keen on striking the right deal.
“We will find a partner who has a good track record of taking a partner molecule to successful conclusion. We have worked in big pharma and know that after a few years priorities can change. So, we will put in some stringent timelines and commitment to put enough resources and money in the contract,” he said.