LAS VEGAS – An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.
VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.
Dr. David M. Pariser
Dr. Pariser served as an . Patients enrolled were aged 18-70 years, with a mean age of 49. Most were men (80%) and white (85%), as is typical in trials for onychomycosis drugs, noted Dr. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk.
Distal subungual onychomycosis was evident in 25%-75% of the nail, and patients needed 2 mm of clear nail to be included in the trial. Disease was confirmed by positive KOH staining and culture.
Patients were randomized into four active treatment groups; a fifth received placebo. All active treatment groups were started on 14 days of a daily loading dose of VT-1161, with one arm getting 300 mg per day and one getting 600 mg per day.
After the loading dose, two groups were treated for 12 weeks with VT-1161 (weekly doses of 300 mg and 600 mg); two other groups had treatment extended out to 24 weeks.
Few patients, roughly 20% in each treatment arm, had achieved the primary endpoint, a complete cure (0% nail involvement and negative KOH stain and culture) at the end of active treatment, Dr. Pariser said.
“I personally think that all of these onychomycosis studies should be carried out for longer than a year, up to 2 years, even if you were able to get rid of all the fungus, because that’s how long it’s going to take for the nail to grow out, especially in older patients with slower nail growth,” Dr. Pariser said.
At 48 weeks, approximately 40% of patients in each active treatment arm achieved complete cure, Dr. Pariser noted. “The results indicated that there was not a lot of difference in outcomes based on the dose the patient received.”
About 60%-70% of treated patients sustained mycologic cure of onychomycosis at 60 weeks.
No serious drug-related adverse events were seen in the study, and no patients dropped out because of lab abnormalities, including liver function tests. Other adverse events were rare and occurred equally in the treatment and placebo arms and consisted of dermatitis, headache, and cough. Nausea, cough, and dysgeusia each occurred in 2% of patients and could have been related to the study drug, Dr. Pariser said.
Looking at both mycologic and complete cure rates of available onychomycosis treatments, the results from the RENOVATE trial are comparable to approved systemic therapies, and superior to topicals, he said.
Dr. Pariser disclosed serving as an investigator for pharmaceutical manufactures Viamet (maker of VT-1161), Valeant, and Ancor/Pharmaderm.
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