Novan Announces Publication of Positive Results from Pivotal Phase 3 Study of Berdazimer Gel, 10.3% (SB206) in Patients with Molluscum Contagiosum in JAMA Dermatology

Rhea-AI Summary

Novan, Inc. (NASDAQ: NOVN) announced positive results from the B-SIMPLE 4 Phase 3 clinical study of berdazimer gel, 10.3%, aimed at treating molluscum contagiosum. This pivotal trial, published in JAMA Dermatology, involved 891 patients and demonstrated significant efficacy with 32.4% achieving complete lesion clearance versus 19.7% in the control group. The gel showed favorable safety profiles, primarily mild side effects. If approved, it could become the first FDA-approved treatment for this viral skin infection, which affects 6 million people annually, particularly children.

Positive

• B-SIMPLE 4 trial involved 891 patients, the largest trial for molluscum contagiosum.
• Berdazimer gel, 10.3% achieved 32.4% complete lesion clearance compared to 19.7% in the control group.
• Overall favorable safety profile with low rates of severe adverse events.
• Statistical significance achieved with a p-value of < 0.0001 for the primary efficacy endpoint.
• Potential to fulfill an unmet need for a prescription treatment for molluscum.

Negative

• None.

– The B-SIMPLE4 pivotal Phase 3 clinical study of berdazimer gel, 10.3% (SB206) is the largest interventional trial of molluscum contagiosum ("molluscum") (n=891)¹ –

– Company previously reported positive topline efficacy and favorable safety data at Week 12 from B-SIMPLE 4 in June 2021, achieving statistical significance for the primary endpoint with p-value less than 0.0001 and no serious adverse events related to treatment with berdazimer gel, 10.3% –

– There are currently no FDA approved prescription therapies available for the treatment of molluscum, a viral skin infection that impacts as many as 6 million people each year, mostly children^2,3 –

DURHAM, N.C., July 13, 2022 /PRNewswire/ -- Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), announced today the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology.¹ Berdazimer gel, 10.3%, Novan's potential first-in-class topical nitric oxide-based prescription treatment, demonstrated favorable efficacy and safety.

"Results from the B-SIMPLE 4 clinical study strongly demonstrate the promise of berdazimer gel, 10.3% as a potential first and only prescription medication for molluscum. The ability for the patient/caregiver to apply a nitric oxide-releasing topical gel to lesions that facilitates complete clearance is a breakthrough in molluscum treatment since many go untreated due to limited options. These study results also showed favorable tolerability which is a key factor in treating children," said Adelaide Herbert, M.D., Chief of Pediatric Dermatology at McGovern School of Medicine and Children's Memorial Hermann Hospital.

Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4, was a multicenter, vehicle-controlled, double-blind study, which enrolled 891 patients across 55 clinics in the United States that were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions as compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema.

Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of berdazimer gel, 10.3% achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of vehicle patients. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a ≥90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients.

"If approved,  berdazimer gel 10.3% could offer pediatricians a way to initiate molluscum treatment with a topical prescription. Unlike current molluscum treatments, like cantheradin or curettage, which often require more than one in-office application, berdazimer could provide molluscum patients or their caregivers the ease of self-applying the gel on the lesions," said Stephan W. Stripling, MD, Co-Medical Director, Coastal Pediatric Research, Charleston, SC.

In June 2021, Novan reported a statistically significant greater treatment effect as compared to vehicle for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12. Overall, berdazimer gel, 10.3% was well tolerated with low discontinuation rates due to adverse events. Although treatment-emergent adverse events (TEAS) were numerically higher in those receiving berdazimer gel, 10.3%, the majority were mild in severity. Local skin reactions (LSRs) were absent in >92% of all patients, except for erythema (redness), which was the most frequently observed LSR in berdazimer gel, 10.3% patients and mostly mild to moderate. Study patients did not exhibit keloid or hypertrophic scars following treatment.

"Novan is proud to have conducted the largest molluscum interventional trial and to have achieved the results we did. If approved, berdazimer gel, 10.3% could be the first FDA-approved prescription product for the treatment of this highly contagious viral skin infection that mostly affects children. We are continuing our preparations to submit a New Drug Application for berdazimer gel, 10.3% and remain on target to do so before the end of 2022," commented Paula Brown Stafford, President and Chief Executive Officer of Novan.   

There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that if approved, topical berdazimer gel, 10.3% as a prescription, self- or caregiver-applied therapy would satisfy an important patient care need for the treatment of molluscum.

About Berdazimer

Berdazimer (sodium), the active ingredient in berdazimer gel, 10.3%, is a new chemical entity. Berdazimer gel, 10.3% is a potential first-in-class topical nitric oxide-releasing agent in Phase 3 development for the treatment of molluscum contagiosum (SB206). Berdazimer gel, 3.4% (SB204), a topical monotherapy in Phase 3 clinical development for the treatment of acne, utilizes the same active ingredient as berdazimer gel, 10.3% and is formulated specifically to address acne.

About Molluscum

Molluscum contagiosum is a common, contagious viral skin infection caused by the molluscipoxvirus,⁴  affecting approximately six million people in the U.S. annually^2,3, with the greatest incidence in children aged one to 14 years.⁵  Infected children typically present with 10 to 30 unsightly lesions,⁶ and, in severe cases, they can have around 100 lesions.⁷  mostly clustering on the face, trunk, limbs and axillary areas.⁶ Over 70% of molluscum patients go untreated.^8,9 There are no U.S. Food and Drug Administration ("FDA") approved therapies for molluscum, with current treatments limited to  potentially painful in-office, healthcare provider-administered physical procedures or cantharidin, or off-label prescriptions and over-the-counter products.^6,10  Molluscum may take a long time to resolve, with lesions persisting 13 months to 5 years^10,11 and transmission of this highly-contagious virus is common, spreading to other children through direct skin contact or sharing contaminated objects like towels.¹² In-household transmission to other children is reported around 41%.¹¹  Despite the prevalence and high transmissibility, there is a significant unmet need in the molluscum treatment landscape.

About Novan

Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates where there are unmet medical needs. We are developing SB206 (berdazimer gel, 10.3%) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum.

Novan recently completed the acquisition of EPI Health. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, the company employs approximately 100 staff, including sales personnel currently covering 42 territories, and promotes products for plaque psoriasis, rosacea, acne and dermatoses. Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe," "expect," "target," "anticipate," "may," "plan," "potential," "will," and similar expressions, and are based on the Company's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company's NITRICIL™ platform technology, the Company's pharmaceutical development of nitric oxide-releasing product candidates, such as berdazimer gel, 10.3% (SB206) for molluscum contagiosum, and the potential benefits of berdazimer gel, 10.3%, if approved. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company's expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company's approach to a potential NDA submission, that the Company's product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company's limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products risks and uncertainties in the Company's ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company's product candidates; any operational or other disruptions as a result of the COVID-19 pandemic; the Company's ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company's product candidates; the Company's reliance on arrangements with third parties to support its operations and its development and manufacturing efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2021, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

References:

1. Browning J, Enloe C, Cartwright, M. Hebert A, Paller A, Hebert D, Kowalewski E, Maeda-Chubachi T. Efficacy and safety of berdazimer 10.3%, a nitric oxide-releasing topical gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Derm. 2022. Epub ahead of print. July 13, 2022. LINK
2. About Molluscum. Accessed July 12, 2022. https://aboutmolluscum.com/  
3. Global molluscum contagiosum epidemiology forecast to 2028 December 16, 2019. Accessed July 12, 2022 https://www.businesswire.com/news/home/20191216005378/en/Global-Molluscum-Contagiosum-Epidemiology-Forecast-to-2028---ResearchAndMarkets.com
4. Chen X, Anstey AV, Bugert JJ. Molluscum contagiosum virus infection. Lancet Infect Dis. 2013;13(10):877-888.
5. Schofield JK, Fleming D, Grindlay D, Williams H. Skin conditions are the commonest new reason people present to general practitioners in England and Wales. Br J Dermatol. 2011;165(5):1044-1050. doi:10.1111/j.1365-2133.2011.10464.x
6. Badri T, Gandhi GR. Molluscum Contagiosum. [Updated 2022 May 1]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441898/ Accessed July 10, 2022.
7. Viral Diseases. In: James, William D ed. Andrews' Diseases of the Skin. 13^th edition. London, UK: Elsevier; 2020: 362-420.e8
8. Syneos. Medical and Pharmacy Benefits Claims, Syneos Insights Suite, 2022 
9. Basdag H, Rainer BM, Cohen BA. Molluscum contagiosum: to treat or not to treat? Experience with 170 children in an outpatient clinic setting in the northeastern United States. Pediatr Dermatol. 2015;32(3):353-357. Ong SK, et al. Pediatr Dermatol. 2021;38(5):1400-1403
10. American Academy of Dermatology. Molluscum contagiosum: Diagnosis and treatment https://www.aad.org/public/diseases/a-z/molluscum-contagiosum-treatment. Accessed July 12, 2022
11. Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15(2):190-195.
12. Meza-Romero R, Navarrette-Dechent C, Downey C. Molluscum contagiosum: an update and review of new perspectives in etiology, diagnosis, and treatment. Clinical, Cosmetic and Investigational Dermatology. 2019;12:373-81.

 

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FAQ

What are the results of NOVN's B-SIMPLE 4 study?

The B-SIMPLE 4 study found that 32.4% of patients treated with berdazimer gel, 10.3%, achieved complete clearance of molluscum lesions, compared to 19.7% in the control group.

When was the B-SIMPLE 4 Phase 3 study completed?

The B-SIMPLE 4 Phase 3 study was completed prior to the publication announcement on July 13, 2022.

What is the significance of the B-SIMPLE 4 trial results?

The results indicate that berdazimer gel, 10.3% could be the first FDA-approved prescription therapy for molluscum contagiosum, addressing a significant unmet need.

What is the next step for NOVN after the B-SIMPLE 4 results?

Novan is preparing to submit a New Drug Application (NDA) for berdazimer gel, 10.3% before the end of 2022.

How many people are affected by molluscum contagiosum annually?

Molluscum contagiosum affects approximately 6 million people in the U.S. each year, with a high incidence in children.