Sienna Biopharmaceuticals Inc (NASDAQ:SNNA) just announced top-line results from a Phase 2b study of SNA-120 (pegcantratinib), the company’s lead drug candidate developed using its proprietary Topical by Design platform. This is an important step for the company in establishing its platform. However, the result failed to achieve its anti-itch goal, which was the primary endpoint.

The stock has been holding onto the $10/share level as support into this data update. However, given the failure to hit the mark on itch relief, we would assume that support will fail this morning. The question is really about how far below this will probe. The balance sheet is in good shape, but the company is really predicated around its new platform at this point, so we could see some rough waters ahead.

Sienna Biopharmaceuticals Inc (NASDAQ:SNNA) frames itself as a clinical-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of topical products in medical dermatology and aesthetics.

The company’s lead product candidates include SNA-120, a first-in-class inhibitor of tropomyosin receptor kinase A, which is in a Phase IIb clinical trial for the treatment of pruritus or itch associated with psoriasis, as well as for psoriasis; and SNA-125, a topical janus kinase 3 inhibitor that is in Phase I/II clinical trials for the treatment of atopic dermatitis, psoriasis, and pruritus.

It also develops SNA-001, a topical suspension of silver particles, which is in pivotal clinical trials for the treatment of acne, as well as for the reduction of light-pigmented hair, including white, gray, blonde, light brown, and light red hair.

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 NCEs by stabily 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 with SNA-120 for use in psoriasis, and SNA-125 for use in atopic dermatitis, psoriasis and pruritus.

The company was formerly known as Sienna Labs, Inc. and changed its name to Sienna Biopharmaceuticals, Inc. in February 2016. Sienna Biopharmaceuticals, Inc. was founded in 2010 and is headquartered in Westlake Village, California.


Revving Up the Machine

As noted above, SNNA just announced top-line results from a Phase 2b study of SNA-120 (pegcantratinib), the Company’s lead drug candidate developed using its proprietary Topical by Design platform

According to the release, this Phase 2b study, in mild-to-moderate psoriasis patients with at least moderate pruritus (itch), was designed to assess the efficacy and safety of SNA-120 on itch (primary endpoint), as well as the underlying psoriasis (secondary endpoints).  In this study, subjects treated with SNA-120 (0.05%) achieved statistical significance, compared to vehicle, on important pre-specified regulatory endpoints of psoriasis disease severity.  Subjects treated with SNA-120 also experienced a meaningful reduction in itch, although the result did not reach statistical significance against vehicle.

“These results, although not entirely as we expected, are very exciting.  While we did not meet our primary endpoint on pruritus, SNA-120 demonstrated statistically significant and clinically meaningful effects on key secondary psoriasis endpoints that were greater than anticipated,” said Frederick C. Beddingfield III, MD, PhD, President and Chief Executive Officer of Sienna Biopharmaceuticals.  “In addition to its significant effect on psoriatic plaques, SNA-120 reduced itch by 58%, although it did not separate from vehicle. This may be partially due to the beneficial emollient effect of the vehicle and the inherent variability in patient-reported assessments.  Taken together, these results demonstrate the potential of SNA-120 as a novel topical, non-steroidal treatment for psoriasis.  Moving ahead, we plan to pursue a psoriasis indication for SNA-120 with pruritus measured as a secondary endpoint.  We expect to start our Phase 3 studies for psoriasis in the second half of 2019.”

Sienna Biopharmaceuticals Inc (NASDAQ:SNNA) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($64.2M against $13.8M).

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