Novan spikes on positive antifungal results
- North Carolina-based Novan’s stock jumped 35% in early-morning trading on the NASDAQ after the biotech announced positive topline results for a mid-stage antifungal treatment.
- The company said Wednesday morning the drug, called SB208, delivered positive results in a Phase 2 study for the treatment of superficial cutaneous fungal infections of the skin and nails.
- Treatment with SB208, a topical, silicone-based gel based on the company's nitric oxide platform, led to statistically significant response in the treatment of athlete’s foot at both 4% and 16% concentrations.
Novan gained almost $2 to trade at $7 per share on Wednesday morning after the results from the 222-patient trial were released.
The results of the study showed four out of five patients receiving the 4% concentration and 74.2% using the 16% concentration achieved a negative fungal culture at 14 days, compared to 45.5% on vehicle.
More than double the number of patients on the gel were considered cured at a four-week follow-up compared to the vehicle treatment.
While the positive results for the antifungal gel is a boon for the small biotech, the trial further confirms that the company’s nitric oxide platform works. The platform is based on an on-demand system of topical delivery of nitric oxide.
"We have now seen clinical evidence of antibacterial, antiviral and antifungal activity with product candidates from our nitric oxide platform. Our ability to deploy antimicrobial doses of nitric oxide in this trial gives us confidence to move forward in the development of a potential treatment for hard-to-treat infections like onychomycosis," said Novan President and CEO Nathan Stasko.
Novan is looking into late-stage options for the treatment and could start a Phase 2 trial in onychomycosis as early as the second half of the year.
The biotech entered the public market last August with a $60 million initial public offering but saw its share value plummet 75% after announcing earlier this year mixed results for its lead acne candidate in two late-stage studies.
- Novan Press release
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