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Evolus touts equal efficacy for its Botox me-too drug in PhIII European/Canadian trials

Coming off the heels of a $80 million IPO to push its wrinkle-reducing drug towards the market, Evolus is trotting out data from a late-stage trial that compares its product to Botox.

The company’s investigational drug, prabotulinmutoxinA 900 kilodalton (kDa) neuromodulator, met its primary endpoints of non-inferiority to Botox at day 30 in patients with moderate to severe glabellar lines (frown lines).

In the European and Canadian Phase III trial, 540 subjects were treated, with 245 getting Evolus’ drug and 246 on Botox. The rest were on placebo. At day 30, investigators saw responder rates of 87.2% in the group receiving Evolus’s drug, 82.8% in the Botox group, and 4.2% in the placebo group.

In-licensed from South Korean firm Daewoong in 2013, Evolus’s drug is a purified botulinum toxin type A complex. Its BLA is currently under review by the FDA (May 15, 2018 PDUFA) and the EMA.

Evolus recently listed on the Nasdaq $EOLS raising $80 million in an IPO. The company’s stock has fallen over 23% since listing, however.


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