Novan to Present Integrated Data from Phase 3 Trials with SB204 for Treatment of Acne
Source: Nasdaq GlobeNewswire / 13 Feb 2018 08:05:23 America/New_York
MORRISVILLE, N.C., Feb. 13, 2018 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today announced that data from the Company’s two Phase 3 clinical trials and long-term safety trial with SB204 for the treatment acne vulgaris will be presented during a Late-breaking Research forum at the 2018 Annual Meeting of the American Academy of Dermatology, or AAD, in San Diego, California.
Newly reported data to be presented in the oral presentation will include pooled results, as well as individual results, of the Phase 3 studies with SB204 in changes in inflammatory, non-inflammatory and total lesion counts and the proportion of patients achieving success on the Investigator Global Assessment, or IGA. Additionally, the presentation will include safety and efficacy results of the 40-week long term open label trial with SB204.
Adelaide Hebert, M.D., is scheduled to present “Evaluation of the Efficacy, Safety, and Tolerability of SB204 4% Once Daily in Subjects with Moderate to Severe Acne Vulgaris Treated Topically for Up to 52 Weeks” on Saturday, February 17, 2018. Dr. Hebert was one of the investigators in this clinical trial and is a board-certified dermatologist and Chief of Pediatric Dermatology at the UTHealth McGovern Medical School, Houston, Texas.
“The pooled efficacy data from the two Phase 3 trials, combined with a sustained treatment benefit over an additional 40 weeks in the long-term safety trial and favorable safety profile, further demonstrate the potential of nitric oxide and its multiple mechanisms of action as a promising treatment for acne,” stated Dr. Hebert. “I am most intrigued by the improvement observed in the severely diseased population treated with SB204. Patients with severe acne have limited treatment options that are safe and accessible, and are in need of well-tolerated topical alternatives.”
About the Presentation
Abstract Number: 6705
Title: “Evaluation of the Efficacy, Safety, and Tolerability of SB204 4% Once Daily in Subjects with Moderate to Severe Acne Vulgaris Treated Topically for Up to 52 Weeks”
Authors: A. Hebert, J. del Rosso, M. Rico, R. Woolson, E. de Leon, C. Enloe, N. Stasko
Presenter: Adelaide Hebert, M.D.
Date and Time: Saturday, Feb. 17, 2017, 10:24 – 10:35 a.m. Pacific Time
Session: F055, Late-breaking Research: Procedural Dermatology
Acne vulgaris is the most common skin condition in the U.S., affecting approximately 40 million to 50 million Americans annually. The disease ranges in severity from mild to severe cystic acne and causes both physical and psychological effects, including permanent scarring, anxiety, depression and poor self-esteem. The complexity of the disease requires treatments that address more than one of the major causes of acne pathogenesis.
Novan, Inc. is a clinical-stage biotechnology company focused on leveraging nitric oxide’s natural antiviral and immunomodulatory mechanisms of action to treat dermatological and oncovirus-mediated diseases. We believe that our ability to conveniently deploy nitric oxide in a solid form, on demand and in localized formulations allows us the potential to significantly improve patient outcomes in a variety of diseases.
This press release contains forward-looking statements including, but not limited to, statements related to our operations and business strategy. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, risks and uncertainties related to our interpretation of data from preclinical studies or clinical trials and other risks and uncertainties described in our annual report filed with the SEC on Form 10-K for the twelve months ended Dec. 31, 2016, and in our subsequent filings with the SEC. These forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
Director, Corporate Communications and Administration