Express Pharma

‘Urgent need to cater to large unmet needs in dermatology’

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Fresh from a $14 million series C financing round, Venkateswarlu Nelabhotla (N Venkat), Co-Founder & CEO, Vyome Biosciences tells Viveka Roychowdhury that their’s is the only company addressing topical antibiotic resistance issue, even though current treatment has been witnessing increased resistance rates

Vyome Biosciences recently closed a $14 million Series C financing round. The US FDA accepted the Investigational New Drug (IND) Application for the initiation of clinical studies of the lead product VB 1953 this January, so by when do you expect the product to go into Phase 1 clinical trials? How long will these trials run? Will India be part of these trials?

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N Venkat

The dosing in humans for VB 1953 is planned in October 2016, we will talk about this separately few days prior to it. We are conducting this trial with a reputed CRO of the US so as to ensure high quality as per US FDA guidelines. Our programme is focussed on the US market therefore India will not be a part of these trials.

With the rise of antibiotic resistant pathogens, many companies are looking at developing drugs which address antimicrobial resistance. Why did your company choose to focus on the dermatology segment? Which other products are in your pipeline?

Dermatology is one therapeutic area where scientific innovation has been very less since last many years. Because of this, most of the antimicrobial drugs for skin pathogens have developed resistance or non-response. Therefore, there is an urgent requirement to cater to large unmet needs in dermatology. After rigorous scientific research and thorough understanding, Vyome’s team has specialised in understanding the skin microbiome and its molecular level mechanics as well as the global issue of antimicrobial resistance, particularly those caused by skin opportunistic pathogens.

We have clinically-tested products based on our breakthrough technology platform targeting antifungal indications Molecular Replacement Therapy (MRT), for which we are currently pursuing commercialisation discussions with multiple partners in various countries. We also have preclinical stage products based on MRT which target multiple skin fungal infections. In addition, we are also developing New Chemical Entities (NCEs) broad spectrum antibiotics based on our innovative technology platform Dual Action Rational Therapeutics (DARTs), which target the antimicrobial resistance caused by skin opportunistic pathogens.

VB 1953 is both a next-generation antibiotic as well as has an IP-protected microtechnology gel system. Could you explain more and are there other clinical candidates in research elsewhere? How does VB 1953 measure up to these future competitors?

Vyome’s product VB 1953 is targeted towards prescription based treatment of antibiotic resistant acne, which constitutes the major patient population suffering from moderate to severe acne.

Topical antibiotics are being used as first line therapy by doctors to treat acne. However, current antibiotic treatment has been witnessing increased resistance rates, at present approximately 40-90 per cent patients for topical antibiotic Clindmaycin varying by countries. This reduces the response rates and leads to dissatisfaction with dermatologists as well as patients. Doctors then prescribe oral antibiotics for treatment of moderate to severe acne which have significant side-effects in patients. Even the response rates of oral antibiotic treatment of patients is ~50 per cent, which leads to worsening of the condition of the patients.

No company apart from Vyome, is addressing the topical antibiotic resistance issue, which is a unique space based on huge unmet need, as there is only one topical antibiotic available for treatment. Clinicians are looking for first in class new topical antibiotic that works on resistant P. acnes. Our product VB 1953 addresses this unmet need and in addition to this, it has anti-inflammatory effect and is less prone to develop resistance.

Vyome Biosciences’ platform strategy seems to offer differentiated new generation antibiotics combined with either better delivery systems as with VB 1953 or dual action (DARTS Platform Strategy) or changing the tissue micro-environment so that the infecting microbe is killed (Molecular Replacement Therapy (MRTTM)). All these are patentable platforms so while being an excellent R&D risk mitigation strategy, will it add to the cost of the therapy?

This is one unique proposition of Vyome’s R&D strategy and programmes such as these platforms create IP value and have different possibilities for commercialisation. However, we are currently focussed on VB 1953 programmes’ clinical development in terms of fund utilisation.

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