Publications

Results of a Phase 2, Randomized,Vehicle-Controlled Study Evaluating the Efficacy,Tolerability, and Safety of Daily or Twice Daily SB204 for the Treatment of Acne Vulgaris

Lawrence F. Eichenfield, MD; Linda Stein Gold, MD; Walter K. Nahm, MD, PhD; Fran E. Cook-Bolden, MD; David M. Pariser, MD

Conclusions: When compared to vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory lesion count and SB204 4% once-daily also significantly decreased the absolute non-inflammatory lesion count in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated.

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Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris

Hilary Baldwin, MD; Daisy Blanco, MD; Charles McKeever, MD; Nelly Paz, MD; Ynca Nina Vasquez, MD; John Quiring, PhD; Carolyn Enloe, MPH; Emily de León, MSCR; Nathan Stasko, PhD

Conclusions: When compared to vehicle, both SB204 1% and SB204 4% significantly decreased the percentage of noninflammatory lesions and SB204 4% also significantly decreased the percentage of inflammatory lesions in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 1% and SB204 4% was safe and well-tolerated.

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Presentations

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.

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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.

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Posters

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

Phase_2b_Poster_Thumbnail.pngLawrence 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.

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

ASM_Microbe_Poster_Thumbnail.jpgKimberly 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

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

E8_Mutant_Thumbnail.pngKimberly 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.

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

SOT_Poster_Thumbnail.pngKimberly 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.

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Pharmacokinetics of SB204 in Subjects with Acne Vulgaris

Pharmacokinetics_of_SB204_in_Acne_Thumb_Nail.jpgM. 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

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

ICAAC_thumb.jpgKimberly 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.

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Antimicrobial Efficacy of a Nitric Oxide-Releasing Drug Candidate in vitro and in vivo Utilizing an Infected Porcine Partial Thickness Burn Wound Model

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Kimberly Coggan, et. al. 

In a biofilm burn wound model, NVN4428 treatment reduced A. baumannii by >5-logs compared to the <2-log reduction observed with SSD treatment on day 4. Similarly, the superiority of NVN4428 over SSD treatment was observed for all tested organisms.  These studies demonstrate that NVN4428 has superior in vivo antimicrobial efficacy over SSD against all tested organisms.

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Comparative Evaluation of Commonly Used Antimicrobial Wound Dressings and Nitric Oxide Treatment of Infected and Non-Infected Full-Thickness Wounds on Swine (Sus scrofa)

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MAJ Robert D. Brodnick, et. al. 

In this set of experiements, nitric oxide-delivering gel formulations provided improved wound healing and antimicrobial activity versus the FDA approved treatments tested, and potentially meet a critical need for improved skin and soft tissue infection (SSTI) therapies.

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Efficacy of Nitric Oxide-Releasing Macromolecules Against Staphylococcus aureus Biofilms

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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.

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

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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.

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

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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.

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Nitric Oxide Advanced Healing Ointment Speeds Re-epithelialization in Excisional and Thermal Porcine Wound Models

porcine.pngSusanne Bauman, et. al. 

These studies demonstrate the ability of topical nitric oxide to speed wound healing and illustrate the importance of evaluating the NOAH ointment dose and frequency of application in future clinical studies.

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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.

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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).

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