Novan Announces Top-Line Data From Mid-Stage Molluscum Study
Zacks Investment Research | Dec 10, 2018 09:22PM ET
Novan, Inc. (NASDAQ:NOVN) announced full top-line data from its phase II study evaluating its topical nitric oxide candidate, SB206, for the treatment of molluscum contagiosum, a skin infection causing lesions. Data included results from the fourth cohort of the study, evaluating SB206 12% once daily. Last month, Novan announced preliminary top-line data from three arms of the study evaluating twice daily dosages of SB206 4%, 8% and 12%.
Data from the study demonstrated that once daily treatment with SB206 12% achieved reductions in molluscum lesions of statistical significance as early as second week of treatment. It also showed that once daily SB206 12% arm achieved the highest rate of complete clearance in patients at week 12.
The phase II study evaluated SB206 in patients aged two years and older with 3 to 70 molluscum lesions. Data from the once daily SB206 12% arm showed that 38% of patients achieved complete clearance rates compared to 18% for the vehicle. Moreover, reduction in lesions from baseline were 29%, 37%, 56% and 55% at week 2, 4, 8 and 12, respectively.
The company is planning to request an end-of-Phase II meeting with the FDA by the end of this year on the back of availability of full data from the study. Novan plans to initiate a phase III study with once daily SB206 12% and will discuss the structure of the study in the meeting. The late-stage study is expected to be initiated in the first half of next year with top-line data anticipated by the end of 2019 or in early 2020.
Novan’s stock has declined 70.1% this year so far compared with a decrease of 11.3% recorded by the industry .
Per the press release, molluscum contagiosum is a contagious skin infection, which affects around 6 million patients in the United States, especially in pediatric patients. There is no FDA- approved treatment available for the disease so far. Meanwhile, over-the-counter products used for treating molluscum have average treatment duration of 13 months. Thus, successful development of SB206 will be a boost for the company as the candidate has better efficacy and a huge patient population.
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