A biodegradable drug-delivery patch met the primary and multiple secondary endpoints in a phase 2b study in patients with oral lichen planus (OLP), a chronic inflammatory condition characterized by lesions and ulcers inside the mouth.
According to AFYX Therapeutics, the study is the largest randomized, double-blind, placebo-controlled study ever conducted in OLP patients. The 20 μg dose Rivelin clobetasol patch (Rivelin-CLO) demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of four weeks, the Copenhagen, Denmark-based company said. Secondary endpoints focused on capturing patient symptomatic improvement also demonstrated statistical significance, AFYX said. The company also noted that no serious adverse events were observed and patients reported overall ease of use and patch adherence to the oral cavity for an average of 90 minutes. The study was conducted in Europe and North America,
"We are excited by the results of this phase 2b study of Rivelin-CLO, which clearly demonstrated first-of-its kind therapeutic benefit for patients with OLP, a condition for which no approved therapies exist," said Nishan de Silva, MD, CEO of AFYX Therapeutics. "Investigators we have been working with have expressed challenges with existing treatment options – topical treatments, ointments, and mouth rinses that don't provide adequate results – and view Rivelin-CLO as an important potential solution for addressing these unmet medical needs."
He said AFYX plans to move into phase 3 clinical studies with the 20 μg Rivelin-CLO patch, based on the strength of the phase 2b results.
The Rivelin-CLO patch uses a novel electrospinning technology to create a patch capable of adhering to the oral cavity for an average of 90 minutes, and to other wet tissue surfaces for about 9.5 hours, while delivering a steady therapeutic dose to the lesion, AFYX said. The company noted that OLP is estimated to affect more than 6 million people in the United States and Europe.
The phase 2b trial enrolled 138 adult patients diagnosed with OLP and who had at least one visible and measurable symptomatic ulcerative lesion. In addition to the placebo arm, the study consisted of three active dose arms (Rivelin-CLO 1μg/patch, Rivelin-CLO 5 μg/patch, and Rivelin-CLO 20 μg/patch).
"Rivelin-CLO adhered to wet tissue inside the mouth of patients with OLP, delivered a steady dose of clobetasol that led to a significant reduction in wound size, and patients were able to easily adhere to the treatment regimen," said Michael Brennan, principal investigator of the study and chair of the Department of Oral Medicine at Atrium Health's Carolinas Medical Center in Charlotte, NC. "This is very encouraging data for a disease that has been overlooked, and I look forward to further evaluating Rivelin in phase 3 studies."