Novan Inc. (NASDAQ: NOVN) announced that it expects its current cash to be adequate for funding the additional third phase pivotal SB206 study in treating patients with molluscum or B-SIMPLE4.
Novan has almost 17 million for conducting phase 3 SB206 trial
Since the beginning of June, Novan has secured around $16.9 million from common shares purchase agreements with Aspire Capital Fund and the exercise of common share warrants that were sold in the March public offering.
The Morrisville based company hopes to commence the third phase trial of its lead drug to treat molluscum, which is a viral skin infection. This trial was not part of the company’s plan in the regulatory approval path for SB206. It was necessitated after the company reported in January that the previous third phase trials didn’t produce statistically significant results despite Company executives indicating that part of the trial data was encouraging. At the time, CEO and President Paula Brown Safford had indicated that the data supported the company’s hypothesis that SB206 had statistically meaningful differences irrespective of the disappointing results.
Novan to commence third phase SB206 trial in September
Novan plans to enroll the first patient in the study for B-SIMPLE4 this summer. If the study commences as scheduled without delay, the company expects to report top-line efficacy in Q2 2021. Stafford indicated that they were pleased to be in a position to conduct the B-SIMPLE4 trial. She added that there is an unmet medical need for molluscum patients, and the company looks forward to advancing the SB206 program.
Early this year, the company set a meeting with the FDA to discuss additional trials for SB206 to secure regulatory approval. Currently, there is no FDA approved therapy for molluscum. The treatment alternatives for patients, especially those aged below 10-years, include in-office, painful, and physician-administered freezing, scraping, blistering, and burning treatments. Patients’ choices are over-the-counter products and off-label prescriptions that do not have any proven clinical safety and efficacy profile.
