Is this the Next Botox? Evolus’s Phase 3 Study Met Primary Endpoints

Botox has long been one the best solutions for smoothing wrinkle lines, managing skin breakouts, lifting lips and more, but botox creator Allergan (NYSE:AGN) may soon have a strong competitor.

On Thursday (April 5) Evolus (NASDAQ:EOLS) announced its EVB-003 study of DWP-450 (prabotulinumtoxinA) had successfully met the primary endpoints for glabellar lines, or “frown lines” compared to its Botox competitor.

According to the release, the initial results of the study were presented at the annual American Academy of Dermatology meeting held in February of this year.

“Analysis of this study presented at AMWC shows that [DWP-450] met its primary endpoint in efficacy as well as its secondary endpoints. In particular, the secondary endpoint of subject satisfaction is important because it represents the opinions of consumers who underwent the treatment,” Dr. Patricia Ogilvie, principal investigator of the study said in the press release.  “Based on these findings, we believe that prabotulinumtoxinA represents a compelling and innovative option for the aesthetic treatment of glabellar lines.”

EVB-003 was a 150 day multicenter, randomized, double-blind, active and placebo-controlled single-dose Phase III study, evaltuating prabotulinumtoxinA and onabotulinumtoxinA  in subjects who felt their glabellar lines had an “important psychological impact.” ‘

Adults aged 18 and older who met the criteria of moderate to severe glabellar lines were assessed according to a 4-point Glabellar Line scale, with 3 ranking as the most severe.

By day 30 of the study 87.2 percent of the patients in the DWP-450 group met the primary endpoints.

DWP-450 Biologics License application is under review by the US Food and Drug Administration (FDA) for temporary improvement in the glabellar lines appearance. The marketing authorization application is under review by the European Medicines Agency, which is for moderate to severe vertical lines between the eyebrows seen at maximum frown.

Evolus is a medical aesthetics company dedicated to bringing advanced aesthetic procedures, with a focus on the self-pay aesthetic market. DWP-450 is the company’s lead product candidate, which is an injectable 900 kDa purified botulinum complex.

Investor Takeaway

Despite Thursday’s news, the company’s share price dropped 15.81 percent from $9.36 to $7.86 as of 3 p.m. Friday (April 6).

Cantor Fitzgerald analyst Louise Chen doesn’t have the same sentiments, he reiterated a “buy” rating on Evolus and set a price target of $25.00. Chen said the basis for the decision was on a variety of milestones for DWP-450 including, “There has been no change to Evolus’s PDUFA date despite the manufacturing observations. But, we still expect U.S. approval around the summer of this year and EU approval at the end of the year,” he said in the report.

Analyst, Irina Rivkind Koffler with Mizuho Securities assigned the company a “buy” rating as well with a $21.00 price target last month. Rivkind Koffler said in the report, “We expect Evolus and its low-cost toxin to carve out a niche in the attractive cash-pay cosmetic market.”

Evolus just reached announced its initial public offering in early February at $12.00. The year should be going up for the company as investors gain trust and regulatory milestones are reached.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.