Apr. 01, 2019 (Life Science Leader) -- Vyome Therapeutics has built platforms and is developing products that address antibiotic resistance in severe skin conditions. The mostly topical products not only kill bacteria and fungal microbes, they are engineered to impede microbial resistance to conventional antibiotics and have other therapeutic effects, such as lowering inflammation. Most of the products have gone through preclinical tests and are in early to midstage clinical development. Some are in partnerships or are planned for partnering. The lead pipeline drug is a topical treatment for antibiotic- resistant acne entering a Phase 2b trial in the second quarter of this year.
What's At Stake
Transitions challenge every company, but maybe biopharmas most of all. Drug development consists of a series of big steps, each one bringing a dramatic increase in the scale of a company’s expertise, operations, and risk-taking. Vyome is reaching the cusp of an upcoming Phase 2b trial, and it faces its greatest transition so far as a small company. With roots in India but new headquarters in Princeton, NJ, Vyome must now play for much higher stakes in focusing its dermatology portfolio on the U.S. market.
The company’s lead product, VB 1953 — slated to begin a Phase 2b trial for antibiotic-resistant acne this year — would enter an impressive U.S. market of about 10 million patients with antibiotic- resistant P. acnes. VB 1953 exemplifies most of the other dermatology agents in the pipeline as a product of mechanistic knowledge applied to skin conditions; it is a product of the company’s Dual Action Rational Therapeutics (DART) technology engineered to have high potency against antibiotic- resistant Propionibacterium acne and other bacteria involved in acne. Vyome is one of a small group of startups taking new approaches to skin disease. Last month, this column featured another skin-focused company, Azitra, which uses a synthetic biology platform to engineer biotherapeutics. Vyome uncovers the functional genomics of resistant micro-organisms and constructs drug molecules to inhibit the resistance mechanisms.
Venkat Nelabhotla, CEO, further explains how the company’s approach applies to acne: “The American Association of Dermatology recommends use of an antibiotic, along with benzoyl peroxide, as first-line therapy for acne with inflammatory lesions. Only the topical antibiotic clindamycin has been available, but it produces drug resistance and has become less effective in terms of cure rates. Our new antibiotic works on the clindamycin-resistant strains of bacteria and also reduces inflammation and makes it very hard for drug resistance to develop.”
Vyome has another platform, Molecular Replacement Therapeutics (MRT), which it has applied to potentiating current antifungal agents. MRT targets particular biomolecules in infected tissue that are essential to the infecting microbe’s growth, replacing them with molecules that impede the growth. The MRT agent “replaces an essential fatty acid in the fungus and causes membrane disruption,” according to the company. Vyome is offering about a half-dozen other MRT candidates for development partnerships.
To gear up for the VB 1953 Phase 2b and further trials for its other products in the United States, Vyome has brought in U.S. scientific, medical, and business expertise to augment its original Indian team. U.S. experts now sit on the company’s board and scientific advisory panel, and the chief medical officer, a senior VP of product development, and other senior life science advisors are also U.S.-based. Vyome is hedging its bets with a full pipeline but does not appear to be clogging its arteries with too many simultaneous projects. Its plans for transition to a U.S. focus leave plenty of room for future growth in products and markets, even globally. If clinical results ultimately support FDA approvals for its products, it will be interesting, and probably instructive, to see how well the company manages this transition.
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