At a time when many Indian generic stalwarts are looking at pursuing the Holy Grail of drug discovery, a hardly five-year-old upstart drug development services firm is making news by successfully taking a new diabetes molecule through Phase I studies.

Backed by India’s most powerful business conglomerate Tata Group, Advinus Therapeutics has struck the high portals of drug discovery with its novel molecule code-named GKM 001 at a pace that would sound amazing even for innovator firms. In addition to this molecule for type 2 diabetes, Advinus has an active pipeline of candidates targeting obesity, COPD and tropical infections.

Advinus, which operates from the western and southern Indian cities of Pune and Bangalore, would like to leverage the advantages of India while maintaining global quality and speed. Currently, the company has several drug discovery partnerships with global drug firms.

GKM 001, a glucokinase modulator, will have a clear edge
over existing approaches to type 2 diabetes, believes Dr. Rashmi H. Barbhaiya, Advinus’ chief executive officer, managing director and a co-founder. Dr. Barbhaiya has 30 years of experience in R&D, working with Bristol-Myers Squibb and Ranbaxy, now part of Daiichi-Sankyo.

Contract Pharma: Within a short span of five years, Advinus managed to identify several potential leads and successfully brought in its first drug molecule up to the proof-of-concept stage. What do you consider the basic strengths that helped Advinus reach this milestone so soon?

Dr. Rashmi H. Barbhaiya: Our primary strength is our people. This is coupled with our hands-on experience on discovering and developing new medicines, our credibility and network in the pharma R&D world and culture of innovation we have nurtured within the company. Last but not the least is the support from our board and the Tata group.

CP: Do you think Advinus’ model can be a good example of how the skill sets of Indian pharmaceutical researchers can be harnessed to expedite the drug discovery process? Can such collaborations with Indian firms help innovators save precious time and resources?

RHB: This is one of the key advantages we offer to our partners. Because of our reduced cost, we offer options for either more “shots on goal” or deployment of more people for a given budget. Each of the two options can save time. Since Advinus is a small boutique company, we do not have the bureaucracy of large organizations and do not have to go through multiple committees to make decisions. Innovation by definition requires taking risks. Since we are small and young, calculated risk taking is in our DNA. We do not have past legacies and set ways of doing things, and that allows us to approach each issue on its own merit with an open mind.

CP: At the moment, several new therapies are reportedly in development to address the condition of diabetes. Advinus’ lead molecule, GKM 001, also falls in the diabetes segment. Can Advinus’ molecule make a difference in the existing or emerging therapies?

RHB: We have designed our clinical molecule and current discovery programs with a clear differentiation strategy and with a projection of clinical needs and market in the year 2017 and beyond. Results from our Phase I trials on our first molecule are very encouraging and all subsequent clinical trials will be designed to keep the differentiation strategy in mind.

A number of GK (glucokinase) activators have shown unacceptable hypoglycemia in humans. Due to this side effect, further development of a number of GK activators has been terminated. Our GK activator has shown evidence for efficacy and has shown no sign of hypoglycemia over a 40-fold dose range. It is also liver selective.

We plan to establish proof of concept in humans and look for a partner with a track record of developing and marketing molecules for diabetes.

CP: Advinus is currently handling several IND projects for leading pharmaceutical and biotechnology companies. What are the value propositions Advinus offers in terms of drug discovery services?

RHB: At this time we do not provide services for drug discovery. We do have risk/reward sharing discovery alliances. We do provide services for drug development. We have capabilities and bandwidth to develop CMC as well as pharmacology/toxicology package for an IND. This capability in itself differentiates us from most other Indian service providers.

CP: What makes Advinus stand apart from the peers in drug discovery research in India?

RHB: We have high respect for some outstanding players from India, so it is not appropriate for me to comment on this question.Our philosophy on drug discovery entails principles such as recruiting, retaining and developing the best talent, taking calculated risk and challenging conventional wisdom. We have science-driven approaches as well as decision making – when required we ignore the “drug discovery manual” for selecting a drug candidate.

And we explore only areas of unmet clinical needs.

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached atharachand@gmail.com.