Vyome Biosciences Administers First In-human Dose of VB 1953 in U.S. Phase 1 Clinical Study in Patients with Facial Acne Vulgaris

NEW DELHI–(BUSINESS WIRE)–Vyome
Biosciences, a clinical-stage specialty biopharmaceutical
company developing novel medicines for treating skin diseases caused by
resistant microbes, today announced that it administered the first
in-human dose of its lead candidate VB 1953 in its Phase 1 clinical
trial being conducted in the United States to treat patients with
moderate to severe facial acne.

This open-label study is designed to evaluate the safety, tolerability
and pharmacokinetics of VB 1953, a topically administered gel developed
to treat patients with moderate to severe acne. According to the study
protocol, VB 1953 will be administered twice daily for a treatment
period of 14 days following a 30-day screening period. The clinical
study, which is being conducted by a CRO (Therapeutics Inc.), continues
to enroll patients at a single clinical site; Therapeutics Clinical
Research, in San Diego, CA.

“Microbial resistance often limits the effectiveness of treatment of
moderate to severe acne. We are looking forward to evaluating VB 1953 in
this patient population,” said Investigator Neal Bhatia, MD, of
Therapeutics Clinical Research.

“One-third of patients with moderate to severe acne do not respond to
available treatment options which is due, at least in part, to microbial
resistance. We believe VB 1953 can address this significant unmet need.
This milestone is an important step in that direction,” said
Venkateswarlu Nelabhotla (N. Venkat), Co-founder and Chief Executive
Officer of Vyome Biosciences.

About Acne

Approximately 240 million people are diagnosed with moderate to severe
acne globally, and studies show that nearly 40 percent of these patients
are affected by antibiotic resistance. According to the American Academy
of Dermatology, acne represents the most common skin disease, affecting
40-50 million people in the United States alone, including 85 percent of
teenagers.

About VB 1953

VB 1953 is Vyome Biosciences’ lead program focused on the treatment of
antibiotic resistant acne. It is currently in evaluation in U.S. FDA
Phase 1 clinical studies. As a first-in-class topical treatment option,
VB 1953 has bactericidal properties, addresses antibiotic resistance and
also exerts an anti-inflammatory effect. Vyome has developed the product
using micro-technology gel system that optimizes skin deposition and
minimizes systemic exposure.

About Vyome Biosciences

Vyome Biosciences is an innovation-driven, clinical stage specialty
bio-pharmaceutical company, which has novel platform technologies and a
deep pipeline that addresses drug-resistant skin opportunistic pathogens
such as antibiotic resistant acne. Vyome’s lead program VB 1953, which
targets the unmet need of antibiotic resistant acne, is currently under
evaluation in U.S. FDA Phase 1 clinical studies. Vyome also has a deep
pipeline of preclinical new chemical entities, unique in their ability
to overcome the development of resistance based on patented Dual Action
Rational Therapeutics (DARTs) technology. In addition, Vyome has
developed clinically proven antifungal products based on an innovative
technology platform, Molecular Replacement Therapy (MRT™). Vyome has
assembled a world-class team of scientific experts from India and the
United States who have a track record of conducting scientific research,
developing breakthrough products and building sustainable businesses.
More information is available at http://www.vyome.in

Contacts

For Vyome Biosciences
Nic DiBella, +1-617-945-5183
nic@jpa.com