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NOVN

Novan

$2.45

-0.055 (-2.20%)

06:34
08/20/18
08/20
06:34
08/20/18
06:34

Novan reports 'positive' clinical results with SB414

Novan announced an update on the SB414 nitric oxide-releasing cream product candidate and its application to two therapeutic indications: atopic dermatitis and psoriasis. Based on results of two complementary Phase 1b clinical trials with SB414 in patients with psoriasis and atopic dermatitis, Novan intends to advance the development of SB414 as a treatment for atopic dermatitis and conduct additional exploratory trials in psoriasis and acne rosacea. The Phase 1b trial design for atopic dermatitis was purposefully short in duration and small in sample size and, as such, substantive clinical efficacy data was not expected to be generated. However, the Company observed that the mean changes in EASI scores were more favorable for SB414-treated patients than those on vehicle. Directional consistency in the clinical data further reinforces the strong correlation with key biomarker signals. In the Phase 1b trial for mild-to-moderate chronic plaque psoriasis, 36 adults received SB414 6% cream or vehicle twice daily for four weeks. Analysis of the data revealed that various known biomarkers related to psoriasis were not downregulated after four weeks of treatment with SB414 6%. Both doses of SB414 were safe as defined by no serious adverse events and SB414 2% was more tolerable with no patients discontinuing treatment in the trial due to application site reactions. SB414 at the 6% dose was not consistently effective in reducing biomarkers across both the atopic dermatitis and psoriasis trials. This lack of consistent biomarker movement could potentially be explained by the increased irritation score experienced by patients treated with SB414 6% in both trials. Additionally, SB414 6% showed detectable systemic exposure in a subset of patients, which cleared in nearly all affected patients within 12 hours. Given the successful downregulation of key biomarkers, favorable tolerability and lack of systemic exposure with SB414 2%, Novan intends to advance the development of SB414 as a treatment for atopic dermatitis and explore the use of lower doses of SB414 in psoriasis

NOVN Novan
$2.45

-0.055 (-2.20%)

05/21/18
JMPS
05/21/18
NO CHANGE
JMPS
Novan Q1 results beat estimates, pipeline progressing, says JMP Securities
JMP Securities analyst Donald Ellis noted that Novan reported Q1 earnings that were ahead of JMP's estimate and the consensus estimate, and added that the company's pipeline is progressing with multiple Phase 1/Phase 2 study top-line results expected later this year. Ellis reiterated a Market Outperform rating and $14 price target on Novan shares.

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