Sienna Biopharmaceuticals Announces First Patient Dosed in Phase 2b Trial of Topical SNA-120
-- Trial to Enroll Approximately 190 Patients with Pruritus Associated with Psoriasis
-- Top-Line Results Expected in First Half of 2019
“We are excited to announce the start of this trial for our lead product candidate, SNA-120, from our Topical by Design™ platform,” said
“Sienna is taking a truly unique approach to the treatment of the signs and symptoms of psoriasis by targeting neurogenic inflammation topically via the NGF-TrkA signaling pathway,” said
Patients will be randomized in a 1:1:1 ratio to one of two concentrations of SNA-120 (0.05% or 0.5%) or vehicle and treated twice daily for 12 weeks. The primary endpoint is the change in pruritus on the 11-point itch Numeric Rating Scale from baseline to week 8. Secondary endpoints include the proportion of patients achieving improvement in the five-point Investigator Global Assessment from baseline to week 12 and the proportion of patients achieving PASI-50, or at least a 50% improvement in the Psoriasis Area and Severity Index, from baseline to week 12. The trial will be conducted at approximately 20 centers in
With the commencement of this Phase 2b trial, Sienna will make a
For more information, visit the Company’s website at www.SiennaBio.com.
This press release contains forward-looking statements, including but not limited to the statements by Sienna’s Chief Executive Officer and Chief Medical Officer and other statements regarding Sienna’s expectations regarding its Phase 2b clinical trial of SNA-120, including the number of patients and centers it anticipates will participate in the study, expected timing to complete the study and report data, potential benefits to patients suffering from the itch associated with pruritus as well as psoriasis itself, and the potential benefits of SNA-120 relative to biologic treatments and other topical treatments. Such forward-looking statements involve substantial risks and uncertainties that could cause Sienna’s 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 drug development process, including the clinical trial enrollment process, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Sienna’s 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 Sienna’s product 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 Sienna’s most recent Quarterly Report on Form 10-Q and any subsequent current and periodic reports filed with the
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Source: Sienna Biopharmaceuticals, Inc.