- Sienna Biopharmaceuticals announced Monday its acne treatment fell short in two separate pivotal trials, failing to outperform a control vehicle in achieving its primary and secondary endpoints.
- President and CEO Frederick C. Beddingfield III said the company was "obviously disappointed" by the results of SNA-001 in a morning conference call but is not giving up on it. He said Sienna remains optimistic on the product's use in light-pigmented hair reduction, with pivotal trial results expected in late 2018 and early 2019.
- As a result of the trial misses, the dermatology and aesthetics company saw its stock tumble down more than 10% in the first few hours of trading Monday.
Editor's Note: The headline of the article has been changed to reflect that SNA-001 is technically classified as a medical device, and not a drug-device combo.
Sienna released top-line data on two randomized, split-face tests using a vehicle to test SNA-001's efficacy. SNA-001 is a topical treatment that can be a gel, cream or ointment composed of silver photoparticles, which is applied to the skin before the area is treated with a laser.
One test used a 810-nm laser and one used a 1,064-nm laser. As Beddingfield laid it out in the call, the data was "clear and unambiguous" in showing no additional benefit from SNA-001.
The primary endpoint was percentage change in inflammatory lesion count after 12 weeks from final treatment.
With the 810-nm laser on 78 people, SNA-001 did less than one percentage point better than the control in percentage change of lesion count. In the other study using the 1,064-nm laser, the control arm yielded a greater reduction in inflammatory lesion count.
A third clinical trial with a 755-nm laser is expected to read out in the fourth quarter of 2018. While the clear-cut results from these two trials shed serious doubt that this third one will be any different, Sienna isn't giving up on SNA-001.
Trials are ongoing for the cream's efficacy in reducing unwanted light-pigmented hair. The company expects results to be released in the fourth quarter of 2018 and the first quarter of 2019.
Ken Cacciatore, an equity analyst at Cowen, essentially shrugged at the failure in his analysis, however, moving its price target down 10% from $50 to $45. Cacciatore's optimism hinges upon another Sienna asset, SNA-120, which will treat pruritus associated with psoriasis. Cowen anticipates $500 million in sales by 2026 from that drug.
Sienna also emphasized the diversity of its drug pipeline, focusing on several clinical trials that will be reading out results in coming months.
"We have several additional clinical studies from two separate technology platforms across a number of therapeutic indications and development stages reading out over the next three quarters," Beddingfield said in a statement.