PRINCETON, N.J., May 13, 2019 (GLOBE NEWSWIRE) -- Vyome Therapeutics, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, today presented positive results from two clinical trials testing its lead anti-acne candidate, VB-1953, at the 77th Annual Meeting of the Society for Investigative Dermatology (SID) in Chicago. VB-1953 is a first-in-class, bactericidal, antibiotic topical gel that kills both sensitive and resistant strains of P. acnes, which is a main driver of inflammatory acne. In previous preclinical studies, VB-1953 demonstrated the ability to reduce inflammation by prompting a direct immunomodulatory anti-IL6 effect.
Data presented at SID demonstrated that VB-1953 was not only capable of significantly reducing inflammatory lesions in moderate to severe inflammatory acne, but also showed the ability to reduce inflammatory lesions of those patients who are non-responders or are resistant to the first line antibiotic treatment, clindamycin.
In the first, proof of concept, double-blind, vehicle-controlled randomized study, topical VB-1953 2% gel was tested over a twelve-week period in adult subjects with moderate to severe facial acne vulgaris. The study demonstrated that twelve weeks of treatment with twice-daily (BID) VB-1953 2% resulted in a significant reduction of 71.46% in inflammatory lesions (p<0.05 versus vehicle), in a post-hoc analysis with 40 and 21 evaluable patients in treatment and vehicle arms, respectively. In as early as eight weeks, an approximately 60% reduction in inflammatory lesions was observed after VB-1953 treatment (p<0.01 versus vehicle). Safety signals were similar between vehicle and treated arms.
In the second, open label, single arm, investigator-initiated clinical study, VB-1953 2% gel was tested for efficacy in moderate to severe acne patients who are clindamycin non-responders and who also have clindamycin resistant P.acnes. Treatment with twice-daily VB-1953 resulted in a reduction in absolute inflammatory lesion count from baseline 34.4 ± 6.4 (Mean ± SD) to 16.7 ± 9.0 (p<0.001) at week twelve. The proportion of subjects achieving a IGA success score was 26.3% at twelve weeks of treatment. Resistant bacteria reduced by 94.3% ± 1.0% (p<0.05) within four weeks of treatment with VB-1953.
"We are very encouraged with these early indications of efficacy from studies of VB-1953," said Venkat Nelabhotla, chief executive officer of Vyome Therapeutics. "A mean percentage reduction of 71% in inflammatory lesion count as observed in our proof of concept study with twelve-week monotherapy represents promising potential for this drug candidate. This figure is in line with the efficacious 56% mean reduction in inflammatory acne lesions seen after two weeks of treatment in our phase 1 studies. At only eight weeks, VB-1953 demonstrated a 60% reduction in inflammatory lesions, and it is notable that currently-used antibiotics offer about 50% mean reduction in inflammatory lesion count with twelve weeks of treatment. We look forward to sharing the results of our ongoing 480 patient phase 2 study on moderate to severe inflammatory acne in early 2020."
Angelo Secci M.D., chief medical officer of Vyome Therapeutics, commented: "The results of these studies are meaningful because VB-1953 may not only represent an effective treatment for moderate to severe inflammatory acne, but also an additional option for patients with antibiotic resistant P. acnes. There is a large and growing unmet need to treat antibiotic-resistant acne, which is the next major therapeutic challenge in dermatology, with at least one in three acne patients in the United States alone having antibiotics resistant P. acnes. VB-1953 has the potential to bring significant clinical benefit to this large population of patients."
Vyome’s lead molecule, VB-1953, is a first-in-class topical bactericidal antibiotic clinical drug candidate targeted for moderate to severe inflammatory acne, with a novel mechanism of action that includes inflammation-reducing capabilities as well as the demonstrated ability to treat antibiotic resistant P. acnes strains. VB-1953 is currently being studied in a Phase 2 clinical trial in the United States. In preclinical studies, VB-1953 showed activity against clindamycin-resistant P. acnes bacteria, a low emergence of resistance and the ability to reduce inflammation. VB-1953 is delivered with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. Acne caused by antibacterial-resistant P. acnes currently poses an emerging and unmet need for patients worldwide, with a potential $2B market opportunity in the US alone.
About Vyome Therapeutics
Vyome Therapeutics is a clinical stage specialty pharmaceutical company based in Princeton, New Jersey, developing a deep pipeline of drugs for the treatment of drug-resistant skin pathogens, including antibiotic-resistant P. acnes. Vyome recently closed a $22 million fund raise in January 2019 from new and existing investors, including Perceptive Advisors, Romulus and Iron Pillar. Vyome advanced its lead clinical candidate, VB-1953, into a Phase 2 clinical trial for the treatment of moderate to severe acne.
Vyome has a deep pipeline of preclinical new chemical entities, based on its patented Dual Action Rational Therapeutics (DARTs) technology, which are unique in their ability to overcome antimicrobial resistance. Vyome has developed clinically validated antifungal products based on its innovative and patented technology platform Molecular Replacement Therapeutics (MRT™), a platform for which Vyome has recently signed an out-licensing deal of marketing rights with a large specialty pharmaceutical company. More information is available at http://www.vyometx.com and @VyomeTx.
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