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Discovery and innovation is now thriving in SMEs like Bugworks

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Bugworks Research India is developing a new class of antibiotics and has received a grant from CARB-X, a global initiative to address the gap in antibiotic R&D. V Balasubramanian, Co-founder and President R&D, Bugworks Research India, shares more details about their research, tackling the AMR menace and more

Tell us about the research project which has secured you the Carb X grant?

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V Balasubramanian

Bugworks has unlocked a new paradigm to discover novel antibiotics. Through our innovative approaches, we have developed a stealth strategy by which antibiotics can successfully by-pass efflux pumps, which are a key defense barrier present on the bacterial cell envelope. Our current lead chemical series target the WHO 2017 Critical, Serious and Concerning infection threats. We are progressing a first-in-class novel chemical entity (NCE) that exhibits potent killing of pan-resistant superbugs such as those resistant to colistin, beta-lactams, cephalosporins, carbapenems, fluroquinolones, and difficult to treat pathogens such as Acinetobacteri baumannii, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Klebsiella pneumoniae etc. We will deliver a clinical candidate that will progress through proof of concept studies in human patients by 2020.

How will your project reduce risk of AMR, lower costs associated with resistance and address a public health challenge?

Bacteria evolve continuously and have the ability to break – defuse – avoid – expel the antibiotics developed in the earlier decades. The Bugworks team has developed a new paradigm that allows its antibiotics to overcome the bacterial defense and rapidly kill the organism. We have successfully validated our paradigm through the discovery of multiple novel chemical series.  The successful outcome of our discovery efforts will result in the introduction of a brand new class of antibiotics, which will be effective on all known resistant bacterial strains. This will not only saves millions of lives who are otherwise perishing due to infections that are resistant to all known classes of antibiotics, but also save millions of dollars in extended hospital costs.

When would your project be ready to be commercialised?

We are in pre-clinical development and likely to initiate Phase 1 studies in 2019. Given the push and pull mechanisms for novel antibiotics, we expect an accelerated development timeline and the product in the market within seven years.

How will this grant help you? How have you deployed the investment of $2.6 million?

The grant is valuable for many reasons: one, since it was a globally competitive grant with less than five per cent success in terms of the final award, it is a vindication of the science that is emanating out of our small biotech operation in Bangalore, India. And to be the only company from Asia is indeed a matter of great distinction. Two, it brings non-dilutive funding, covering nearly 75 per cent of the total costs to deliver one candidate drug. Three, it brings with it an ecosystem of the best minds in antibiotic development from a global pool who will provide critical feedback and steer the team. Four, it opens up several investor networks and access to large pharma who have deeper pockets to develop and deliver the final drug.

What is preventing investment and innovation in tackling superbug infections?

The failure to develop novel antibiotics by big pharma in the past decades are well documented. Problems in science are not always solved by infusing vast sums of money. In fact, recent history has shown that the industrialised, proces- driven discovery engines of big pharma has failed spectacularly in yielding novel antibiotics to combat bacterial infections. Innovation happens in creative environments, which are not shackled by the process driven cultures of big pharma. Hence in recent times, discovery and innovation has exited Big Pharma and is now thriving in SMEs like Bugworks. This not only unshackles the creative mind, but also significantly lowers the cost.

Investments into antibiotic discovery are still a trickle compared to other therapy areas such as oncology and cardiovascular diseases.  Even though antibiotics are life saving in most situations, since they have been around for several decades, the common mindset is to pay extremely small sums of money for a course of antibiotics. And a typical course of a successful antibiotic for a patient is a few weeks as opposed to life-long consumption in the case of anti-hypertensive and anti-diabetic medications. Hence the traditional volume-based pharma business model has become less attractive  This has had a spiral effect in terms of investor friendliness as well.

What should be the blueprint to tackle AMR?

AMR is a problem that affects the entire spectrum of clinical practice and is not only a problem when someone contracts infections. This is not easily intuitive to most, who still view AMR as a problem of the infectious disease (ID) specialists in the clinic and microbiologists in the diagnostic labs. Thanks to AMR, simple surgical procedures will become untenable. The most advanced cardio thoracic surgeries to treat heart ailments will be derailed due to the humble drug-resistant bacteria. Cancer treatments, which offer life extensions and improved quality of life, will become useless when the patient now succumbs to infection and not cancer. The point of all this is to shift the focus of AMR from the purview of ID specialists alone to the purview of the entire medical fraternity. It is everyone’s problem and not just the microbiologist’s problem! This will not only increase the awareness, but also increase the investments into the area. The true implementation of the responsible use of antibiotics is a must if we are to succeed in our quest to tackle AMR. Tackling AMR is a combination of scientific innovation, responsible social behavior and strong political will.

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