SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 27, 2018
SIENNA BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
30699 Russell Ranch Road, Suite 140
Westlake Village, CA 91362
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (818) 629-2256
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 8.01 Other Events
On August 27, 2018, Sienna Biopharmaceuticals, Inc. (the Company) announced results from its first-in-human study of SNA-125 in psoriasis. A copy of the Companys press release is filed as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
|99.1||Press Release dated August 27, 2018.|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|SIENNA BIOPHARMACEUTICALS, INC.|
|Date: August 27, 2018||By:|
Timothy K. Andrews
General Counsel and Secretary
Sienna Biopharmaceuticals Announces Results from First-in-Human Study of SNA-125 in Psoriasis and
Continued Progression to Phase 2
Phase 1/2 study data of SNA-125 in atopic dermatitis on track to be released in fourth quarter of 2018
SNA-125 Phase 2 studies expected to begin in second half of 2019
WESTLAKE VILLAGE, Calif., Aug. 27, 2018 Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA), a clinical-stage medical dermatology and aesthetics company, today announced results from a first-in-human study of its investigational new chemical entity SNA-125, a JAK3/TrkA inhibitor being evaluated as a first-in-class topically administered medication to treat mild-to-moderate psoriasis.
SNA-125 was developed using Siennas Topical by Design platform, which yields new chemical entities (NCEs) designed to deliver high local drug concentration in the target tissue with minimal to no systemic exposure for patients. SNA-125 selectively inhibits Janus kinase 3 (JAK3) and tropomyosin receptor kinase A (TrkA). JAK3 inhibition blocks the signaling of key cytokines, resulting in reduced severity of certain autoimmune and inflammatory diseases such as psoriasis. TrkA is the high-affinity receptor for nerve growth factor (NGF), a known mediator of neurogenic inflammation associated with psoriasis, as well as pruritus (itch).
This exploratory Phase 1/2, double-blind, within-subject vehicle-controlled study in 15 subjects, using a psoriasis microplaque model, was designed to measure an effect on inflammatory skin infiltrate thickness, local tolerability, and histology and biomarkers with two doses of SNA-125 prototype gel applied once daily for 10 days.
In this model, SNA-125, the second NCE from Siennas Topical by Design platform, was well-tolerated and showed no safety signals. Neither dose of SNA-125 (0.2 or 2 percent) reduced the inflammatory skin infiltrate thickness from baseline (p>0.8). However, histological and biomarker analyses showed a modest, statistically significant reduction with SNA-125 0.2 percent in epidermal thickness from baseline (-17%, p<0.05), as well as modulation of certain psoriasis-relevant biomarkers and gene expression profiles.
This exploratory study, while limited, showed a modest drug effect and good tolerability with SNA-125, and provides us with directional information to help guide the design of our Phase 2 development program, said Frederick C. Beddingfield III, MD, PhD, President and Chief Executive Officer of Sienna Biopharmaceuticals. Of course, we would have liked to have seen more robust impact in this early-stage model, but treatment with SNA-125 may take longer than ten treatments to reveal its full effect. In parallel with this study, we have developed a more optimal cream formulation to treat inflammatory skin disorders that is undergoing nonclinical testing, and we remain excited about our Phase 2 studies beginning in the second half of 2019. We look forward to additional data from our Topical by Design platform in the fourth quarter of 2018 namely, our SNA-125 Phase 1/2 study in atopic dermatitis, as well as our SNA-120 Phase 2b study in pruritis associated with psoriasis, now that enrollment has been completed ahead of schedule.
Siennas pipeline currently includes five clinical-stage programs:
(from the Companys Topical by Design platform)
SNA-125 for the treatment of atopic dermatitis; Phase 1/2 results expected in the fourth quarter of 2018
SNA-125 Phase 2 studies expected to begin in the second half of 2019
SNA-120 for the treatment of pruritus associated with psoriasis and the underlying psoriasis; Phase 2b top-line results now expected in the fourth quarter of 2018
(from the Companys Topical Photoparticle Therapy platform)
SNA-001 for the reduction of light-pigmented hair
pivotal results with the 1064 nm wavelength laser expected in the fourth quarter of 2018
pivotal results with the 810 nm and with the 755 nm wavelength lasers expected in the first quarter of 2019
SNA-001 for the treatment of acne
pivotal results with the 755 nm wavelength laser expected in the fourth quarter of 2018
About Topical by Design
Topical by Design is an innovative platform, designed to enable the topical application of potent active pharmaceuticals against known biologic targets while minimizing exposure to the systemic circulation, thereby addressing the tolerability trade-offs that often make therapies unsuitable for use in larger segments of the population with less severe disease. Topical by Design applies a scientific design process
to transform molecules into new chemical entities by stably linking a short polyethylene glycol (PEG) polymer to a pharmacologically active molecule. Applying this technology, we have created a pipeline of drug candidates with unique pharmacological profiles to manage a variety of chronic inflammatory and immunologic conditions. Applications for the Topical by Design platform are currently being explored in a Phase 2b trial with SNA-120 for use in pruritus associated with psoriasis, and Phase 1/2 studies with SNA-125 for use in psoriasis and atopic dermatitis.
About Sienna Biopharmaceuticals
Sienna Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on bringing innovations in biotechnology to the discovery, development and commercialization of first-in-class, targeted, topical products in medical dermatology and aesthetics. The Companys objective is to develop a unique, diversified, multi-asset pipeline of topical therapies that enhance the health, appearance and quality of life of dermatology and aesthetics patients. Sienna is led by a management team with extensive experience in product development and commercialization at several leading dermatology, aesthetics and biotechnology companies.
For more information, visit the Companys website at www.SiennaBio.com.
This press release contains forward-looking statements, including but not limited to statements by Siennas Chief Executive Officer and other statements regarding Siennas expectations for the timing of additional data readouts for its clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Siennas clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the pharmaceutical drug and medical device development processes, including the clinical development process, regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing pharmaceutical drug and medical device products, Siennas ability to successfully protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations and the availability or commercial potential of Siennas drug candidates. Sienna undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Siennas most recent Annual Report on Form 10-K and any subsequent current and periodic reports filed with the Securities and Exchange Commission.
Caroline Van Hove
Sienna Biopharmaceuticals, Inc.
30699 Russell Ranch Road, Suite 140, Westlake Village, CA 91362
Office 818-629-2256 | Fax 818-706-1214