Biotechnology company Novan Therapeutics has announced that it has received encouraging results from a phase 2b study analysing a nitric-oxide topical gel candidate drug.
SB204, which is the company’s leading drug candidate for the treatment of acne vulgaris, was used in the trial and produced significant results on inflammatory and non-inflammatory lesions at week 12 on a recorded 213 patients.
All participants were randomly split into five groups:; SB204 2% twice daily, SB204 4% once daily, SB204 4% twice daily and vehicle once or twice daily.
According to the study, the 4% dose of SB204 proved to demonstrate the most significant difference in inflammatory lesions, and the 1% and 4% groups were effective at decreasing non-inflammatory lesions. The study noted that patients treated with SB204 had 80% less sebum on the skin’s surface compared to those in the vehicle groups.
In addition, less than 1% of participants discontinued treatment due to adverse effects, which can include scaling, dryness, itching and burning.
Nathan Stasko, president of Novan Therapeutics, said, “These study results reproduce our phase 2a trial, which showed a similar separation between the active drug and vehicle.”
He continued, “Replicating a 20% differential between SB204 and vehicle in percent lesion reduction gives us great confidence in moving into the phase 3 programme.”
Based on the trial results, Novan announced plans to initiate two phase 3 trials with SB204 once daily in the beginning of 2016, with 1,300 patients expected to be enrolled in each study.