Novan Announces Statistically Significant Phase 2 Clinical Trial Results for SB206
Number of Patients with Complete Clearance of Genital Warts Provides Clinical Evidence of Nitric Oxide Anti-Viral Activity Against HPV
Company Plans End-of-Phase 2 Meeting for First Half of 2017
"These data are impressive. The magnitude of effect with favorable tolerability provides us great enthusiasm for patients suffering from the most common sexually transmitted infection in the United States," said
In this randomized, double-blind, vehicle-controlled clinical trial, the safety and efficacy of SB206 was evaluated in 107 patients with external genital warts and perianal warts. The dose and dosing frequency of SB206 was tested in four independent cohorts in which patients were randomized in a 3:1 ratio to either SB206 or vehicle and treated for up to 12 weeks. SB206 doses included SB206 4% twice-daily, 4% once-daily, 8% once-daily and the highest dose evaluated, 12% once-daily. Patients eligible for this clinical trial were males or females, 18 to 50 years of age, with 2 to 20 warts on the genital or perianal area. The mean wart count burden per patient at baseline was 7.4 warts.
The primary endpoint for this clinical trial was the proportion of patients who were completely clear of warts that were present at baseline at or before week 12. In the intent-to-treat analysis, 33% of patients achieved complete clearance of all warts by week 12 when treated with SB206 12% once-daily, compared to only 4% of patients achieving complete clearance with vehicle once-daily (p=0.0099). In the per-protocol analysis containing patients who completed a full 12 weeks of dosing, 42% of patients achieved complete clearance of all warts when treated with SB206 12% once-daily, compared to only 7% of patients achieving complete clearance with vehicle once-daily (p=0.0200).
The cutaneous tolerability of SB206 was carefully monitored and recorded using scores on a four-point grading scale for erythema, edema, erosions or ulcers and burning or stinging. The once-daily treatment arms were generally well tolerated, including the most effective dose, 12% once-daily. The most frequently reported treatment-emergent adverse events were application site reactions, the percentage of which was highest in patients treated with SB206 4% twice-daily. Based on the local application site adverse-event profile and the Company's strict, pre-specified stopping criteria, SB206 4% twice-daily was discontinued, and all of the remaining cohorts were dosed once-daily.
"I am honored to be part of the SB206 investigative team, and it was exciting to observe the clinical benefits that a number of my patients experienced during the Phase 2 trial," said Dr.
"Our SB206 development program now includes in vitro evidence against high-risk HPV-18 in a human raft cell culture model, in vivo data against papilloma virus in rabbits, and clinical evidence from our Phase 2 trial against genital warts commonly caused by HPV-6 and -11," said Dr.
Based on the data generated in this Phase 2 dose-ranging trial,
About Human Papillomavirus (HPV) and Genital Warts
HPV refers to a large family of double-stranded DNA viruses that induce abnormal growths on the skin or mucosal surfaces. HPV affects nearly 80 million Americans, and an estimated 14 million new cases of the virus are reported each year, according to the
Genital warts are among the world's most common sexually transmitted diseases. Genital warts are usually flesh-colored growths that can be raised, flat or cauliflower-shaped and are typically found on the surface of the external genitalia or in and around the anus. In males, they can appear on the surface of the penis and scrotum, and in females inside the vagina or on the cervix. Genital warts carry a substantial psychosocial burden due to the shame and embarrassment related to having a sexually transmitted disease as well as the inconvenience and discomfort of current treatment modalities. Current treatment options for genital warts consist of ablative procedures that cut, burn or freeze the warts but do not address the underlying viral infection, and there are no currently approved oral or topical prescription products indicated for the treatment of genital warts with a direct anti-viral mechanism of action.
For more information, visit the Company's website at www.Novan.com.
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and future prospects. 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, uncertainties and risks in the clinical development process, including, among others, length, expense, ability to enroll patients, reliance on third parties, and that results of earlier research and preclinical or clinical trials may not be predictive of results, conclusions or interpretations of later research or trials; whether we will be able to obtain additional funding when needed; and other risks and uncertainties described in our prospectus dated