Vyome (NASDAQ:HIND), a clinical-stage company focused on immuno-inflammatory and rare diseases, outlined its strategy for developing therapies in areas with limited treatment options, highlighting its lead topical gel candidate, VT-1953, for symptoms associated with malignant fungating wounds.
Speaking at a Chardan event, Chief Executive Officer and Co-founder Venkat Nelabhotla said the company targets programs with substantial unmet needs or no FDA-approved therapies while seeking to maintain a capital-efficient development model. He said Vyome operates with a lean structure, uses scientific and cost advantages in India for certain development work, and relies on specialist consultants for regulatory-related activities.
Nelabhotla said the company maintains a simple capital structure based on common stock. The event moderator noted that Vyome reported second-quarter operating expenses of about $874,000.
Lead Program Targets Symptoms of Malignant Fungating Wounds
VT-1953 is a 2% topical gel being developed for malignant fungating wounds, which can occur when advanced tumors break through the skin. Shiladitya Sengupta, Vyome’s co-founder and board member and a professor of medicine at Harvard Medical School, said the condition occurs in approximately 10% of advanced cancer patients and is seen in cancers including breast cancer and head and neck cancer.
Sengupta said the wounds can involve infection, exudate formation, pain and severe odor, creating significant challenges for patients and caregivers. He said these symptoms can contribute to psychological distress and social isolation, particularly during the later stages of a patient’s illness.
Vyome is seeking to address the symptoms of the condition rather than the underlying cancer. Sengupta described the company’s approach as identifying unmet patient needs and applying existing drugs based on their mechanisms and established risk profiles.
Existing Safety Data and Pilot Study Results
According to Sengupta, the VT-1953 gel has been evaluated in five clinical studies, including chronic dosing for up to 90 days. He said the product has been tested in more than 400 patients, or nearly 450 patients, and has shown what he described as a relatively clean safety profile. Based on that database, he said the company’s current development emphasis is on demonstrating efficacy in malignant fungating wounds.
The company cited results from an investigator-initiated Phase II pilot study that enrolled 15 patients with severe, malodorous malignant fungating wounds. Ten patients received VT-1953 and five received vehicle, with twice-daily dosing over 14 days.
Sengupta said the study showed a statistically significant reduction in odor versus placebo, with a reported p-value of 0.01. He also said patients receiving the drug experienced reductions in pain and improvements in patient-reported psychological outcomes. In the placebo group, he said there was no improvement and that some patients worsened.
Dual Mechanism and Regulatory Discussions
Sengupta said VT-1953 is intended to have both antibacterial and anti-inflammatory activity. He described the drug as acting on DNA gyrase and inhibiting the MD-2/TLR interaction. While metronidazole is used off-label for malignant fungating wounds, Sengupta said it primarily targets anaerobic bacteria and may not address more than half of the bacterial causes involved in wound symptoms.
He said VT-1953 is designed to target a broader range of bacteria colonizing the wounds while also reducing inflammatory signaling that can contribute to pain and exudate formation.
Nelabhotla said Vyome has an orphan drug designation application pending with the FDA. He said the agency requested additional information, including information related to endpoints because no FDA-approved therapy currently exists for the indication. He also said the company has disclosed plans for a Type C meeting with the FDA.
Regarding a potential registrational study, Nelabhotla said the company previously discussed a trial involving closer to 100 patients but does not yet have a final patient number. He said study design will depend on the next round of FDA interactions. Nelabhotla added that third-party analysts have estimated a U.S. total addressable market of $2.2 billion for the indication.
About Vyome (NASDAQ:HIND)
Vyome is a biotechnology company focused on developing therapies for dermatological conditions. Its research programs are centered on skin diseases involving inflammation, microbial imbalance and antibiotic resistance, with the goal of creating targeted treatments for patients who have limited options.
The company’s pipeline has included topical therapies for acne and other inflammatory skin disorders. Among its reported programs is VB-1953, an investigational topical treatment designed to address acne-causing bacteria while potentially reducing concerns associated with conventional broad-spectrum antibiotics.
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