Presentations

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

Adelaide Hebert, MD, et. al.

In a pooled analysis from two Phase 3 trials (NI-AC301 and NI-AC302), at Week 12, SB204 had statistically significant greater reduction over vehicle in inflammatory lesions, non-inflammatory lesions and total lesions. In the long-term safety study, continuous treatment with SB204 showed further benefit and the 40 week safety profile was consistent with the 12 week trial.

Read more

Nitric Oxide-Releasing Topical Therapeutic Agent for Atopic Dermatitis

Stanley Hollenbach

In two in vivo models that assess critical components of atopic dermatitis disease pathology, SB414 displayed potent anti-staphylococcal activity and dose-dependent inhibition of inflammation comparable to betamethasone, a mid-potency corticosteroid used to treat eczema patients.

Read more

Results From Phase II Study of Nitric Oxide-Releasing SB206 Once Daily Administration Show Favorable Efficacy and Safety in Genital Warts

Stephen Tyring, MD, PhD

In a Phase 2 clinical trial with SB206 for the treatment of genital warts caused by human papillomavirus, or HPV, SB206 12% once-daily led to a statistically significant difference from vehicle in clearance of both baseline and total warts at week 12 and appeared to be safe and well tolerated with a low rate of application site adverse events and low discontinuation rate.

Read more

In Vitro and In Vivo Efficacy of Nitric Oxide-Releasing Antiviral Therapeutics Agents

Kimberly McHale, PhD

The efficacy of topical nitric oxide-releasing therapeutics to inhibit viral replication has been demonstrated in vitro and in vivo.

Read more

Efficacy and Safety of SB204 Gel in the Treatment of Acne Vulgaris Presented at 2016 AAD Annual Meeting

Lawrence F. Eichenfield, MD

A multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel-group study evaluating the efficacy, tolerability, and safety of SB204 gel once or twice daily in the treatment of acne vulgaris over 12 weeks.

Read more

 

Posters

Effects of SB414 Cream on S. aureus and Tissue Cytokines in an Atopic Dermatitis Mouse Model

Stan Hollenbach, et. al.

SB414 reduced IL-4 by 87% and IL-13 by 76% compared to placebo treated mice in an atopic dermatitis in vivo model. SA levels in the skin of SB414-treated mice were decreased to 0.5 x 105 CFUs, representing a >90% reduction over untreated and vehicle treated mice.

Topical Nitric Oxide-Releasing Therapy with SB208 Increased Fingernail Growth

Tomoko Maeda-Chubachi, MD, et. al.

SB208 16% demonstrated statistically significant greater mean daily nail growth rate for the treatment period for the average of both target nails when compared with run-in period.

Efficacy and Safety of SB208, an Investigational Topical Nitric Oxide-Releasing Gel, in a Phase 2 Study of Subjects with Interdigital Tinea Pedis for the Treatment of Interdigital Tinea Pedis

Daisy Blanco, MD, et. al.

SB208 4% and 16% demonstrated a treatment effect (p<0.05) against interdigital tinea pedis in mycological cure which warrants further development in additional efficacy clinical trials

Efficacy, Tolerability and Safety of SB204 Gel in Adolescent (9 to 17 Years of Age) With Acne Vulgaris

Diane Thiboutot, MD, et. al.

In a subset of only adolescent subjects (9 to 17 years of age) treated with topical SB204 4% once-daily, there was a statistically significant reduction (p<0.05) in inflammatory, non-inflammatory and total lesion reductions with SB204 4% compared to vehicle
 

Assessment of Pharmacokinetics and Safety of Investigational Nitric Oxide-Releasing SB204 Gel in Adolescents With Acne Vulgaris

Diane Thiboutot, MD, et. al.

SB204 4% once daily showed a statistically significant reduction in inflammatory, non-inflammatory and total lesions while maintaining a good safety and tolerability profile in adolescent subjects in NI-AC301 and NI-AC302.

Read more

Effects of SB204 on LPS-induced Cytokine Release in an Ex-Vivo Human Skin Model

Kimberly McHale, PhD, et. al.

A single application of SB204 4% significantly inhibited the upregulation of IL-1β by approximately 62% as compared to untreated controls (n of 6 donors, p=0.045).

Read more

Preclinical Evidence for Nitric Oxide-Releasing SB414 in a Psoriasis Animal Model

Stanley Hollenbach

In a psoriasis mouse model, SB414 significantly (p<0.05) reduced composite psoriasis scores and also inhibited the production of pro-inflammatory cytokines, including interleukin-17, or IL-17a and IL-17f.

Read more

Nitric Oxide-Releasing Topical Therapeutic Agent for Atopic Dermatitis

Stanley Hollenbach

In two in vivo models that assess critical components of atopic dermatitis disease pathology, SB414 displayed potent anti-staphylococcal activity and dose-dependent inhibition of inflammation comparable to betamethasone, a mid-potency corticosteroid used to treat eczema patients.

Read more

Pharmacokinetics of SB204 in Subjects with Acne Vulgaris

M. Joyce Rico, MD

In three pharmacokinetic clinical trials conducted in patients with moderate to severe acne to assess systemic exposure following topical application of SB204, there was no detectable systemic exposure to markers for nitric oxide exposure in adults or adolescents treated with SB204 under maximal use conditions.

Read more

Antiviral Effects of Nitric Oxide-Releasing Drug Candidates in Suppressing Productive Infection of HPV-18 in an Organotypic Epithelial Raft Culture Model System

Thomas R. Broker, PhD

Novan’s nitric oxide-releasing drug candidates significantly inhibited the high-risk HPV-18 genotype and reduced the E6 viral protein in an in vitro raft culture model.

Read more

A Phase 2b Study of Efficacy and Safety of SB204 Gel in the Treatment of Acne Vulgaris

Lawrence F. Eichenfield, MD, et. al. 

A multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel-group study evaluating the efficacy, tolerability, and safety of SB204 gel once or twice daily in the treatment of acne vulgaris over 12 weeks.

Read more

In Vitro Nail Penetration of Nitric Oxide-releasing Formulations for the Topical Treatment of Onychomycosis

Kimberly McHale, et. al. 

In an in vitro human nail penetration study, nitric oxide-releasing formulations demonstrated rapid penetration of the nail and effective fungal killing of Trichophyton rubrum in 24 hours following a single treatment application

Read more

In Vitro and In Vivo Efficacy of Nitric Oxide-Releasing Antiviral Therapeutic Agents

Kimberly McHale, et. al. 

In virally-infected organotypic cultures, HPV-18 viral replication was significantly inhibited following 6 days of daily 1 hour treatment with nitric oxide-releasing macromolecules.  Additionally, topical treatment with Novan's product candidate, SB206, demonstrated a dose responsive pharmacological effect against both wild type and E8 mutant papillomavirus in the Cottontail Rabbit Model.

Read more

Oral and Intravenous Pharmacokinetics of NVN1000, a Nitric Oxide Donating Macromolecule, in Minature Swine

Kimberly McHale, et. al. 

In the data presented, correlations showed tight associations between the active and inactive components of the NVN1000 molecule as it is metabolized in vivo and identified hMAP3 as the appropriate analyte to demonstrate NVN1000 systemic exposure.

Read more

Pharmacokinetics of SB204 in Subjects with Acne Vulgaris

M. Joyce Rico, et. al. 

The data presented herein demonstrate that, following topical application of SB204, there was no measureable systemic exposure in patient with acne vulgaris.  SB204 was generally well-tolerated and not associated with any significant safety issues under maximal use conditions in a Phase 1 clinical study in adults with moderate-to-severe acne

Read more

Antiviral Efficacy of Nitric Oxide-Releasing Drug Candidates In Vivo Utilizing the Cottontail Rabbit Papillomavirus Model

Kimberly Coggan, et. al. 

The data presented herein demonstrate for the first time inhibition of papilloma growth in vivo following topical NO treatment in an animal model. This novel treatment approach may be beneficial for the treatment of extra genital warts and may reduce the incidence of HPV associated cancers.

Read more

Efficacy of Nitric Oxide-Releasing Macromolecules Against Staphylococcus aureus Biofilms

Kimberly Coggan, et. al. 

These data suggest that Nitricil macromolecules exhibit robust antimicrobial activity against both planktonic and biofilm-embedded S. aureus and may be an effective therapy for the treatment of chronic S. aureus infections.

Read more

Susceptibility of Staphylococcus aureus to Nitric Oxide-Releasing Macromolecules and Assessment of Resistance

Kimberly Coggan, et. al. 

These data suggest that lower magnitude, more sustained release profiles of nitric oxide from NVN4428 provide greater antimicrobial activity against S. aureus than the high-burst, short half-life of nitric oxide release from NVN1000. Furthermore, S. aureus strains exhibit a low propensity of developing resistance to NVN1000 or NVN4428.

Read more

Phase 2 Study of Efficacy and Safety of SB204 in the Treatment of Acne Vulgaris

M. Joyce Rico, et. al. 

The higher dose of SB204 (4%) demonstrated a statistically significant difference in inflammatory lesion counts and both 1% and 4% were effective at decreasing non-inflammatory lesions in subjects with acne vulgaris treated for 12 weeks.

Read more

 

White Papers

Nitric Oxide is Bactericidal to the ESKAPE Pathogens:  Time for a radical approach

Kimberly Coggan, Ph.D.

Novan Therapeutics conducted research on two nitric oxide-based drug candidates that demonstrate an ability to kill the ESKAPE pathogens. These pathogens are the antibiotic-resistant bacteria that are responsible for the majority of U.S. hospital infections and a growing number of drug-resistant infections among otherwise healthy non-hospitalized patients.

Read more

Topical Nitric Oxide: A First in Class Local Antiandrogen Therapy

William Kelce, Ph.D.

Novan Therapeutics reports topical nitric oxide-based therapies may reduce androgen levels in the skin by locally inhibiting skin steroidogenesis.  The targeted reduction of androgens in the skin could lead to first-in-class local antiandrogen products to treat acne and androgenic alopecia (male pattern baldness).

Read more

Close
Close