Profile: Evolus Inc (EOLS.OQ)
17 Oct 2019
Evolus, Inc., incorporated on November 9, 2012, is a medical aesthetics company. The Company is focused on providing physicians and aesthetic procedures and treatments. It also focuses on offering the self-pay aesthetic market and its product candidate, PrabotulinumtoxinA (DWP-450), is an injectable 900 kilodalton, or kDa, botulinum toxin type designed to address the needs of the large and growing facial aesthetics market. It offers physicians and patients a compelling value proposition with DWP-450. OnabotulinumtoxinA (BOTOX) is the neurotoxin approved 900 kDa botulinum toxin type A complex in the United States.
The Company has completed the clinical development program for DWP-450 for the treatment of moderate to severe glabellar lines, also known as frown lines, between the eyebrows, in the United States, European Union, and Canada. The Company’s five-study DWP-450 clinical development programs, include EV-001, EV-002, EVB-003, EV-004 and EV-006. In the United States-based studies, EV-001, EV-002, EV-004 and EV-006, additional testing conducted, such as chemistry, hematology, urinalysis, and electrocardiograms. The DWP-450 formulation for the EV-004 study used a lyophilizing, or freeze drying, method for removing water. The pivotal studies EV-001 and EV-002, and the repeat dose study EV-006, used a DWP-450 formulation. This vacuum dried formulation is tested for antibotulinum antibody formations in 1,739 DWP-450 treatments in the 570 subjects in the repeat treatment EV-006 trial, and 492 DWP-450 treatments in the two United States single treatment Phase III trials, EV-001 and EV-002.
The Company five studies contributed data to the evaluation of efficacy and safety. In the three multicenter, randomized, double-blind, controlled, single dose Phase III studies (EV-001, EV-002 and EVB-003), 1,194 subjects participated. The two identical placebo-controlled United States pivotal studies, EV-001 and EV-002, enrolled 654 subjects in total. The placebo and active controlled EU pivotal study, EVB-003, enrolled 540 subjects. 20 units of BOTOX served as the active control in EVB-003. In addition, 922 subjects participated in the two multicenter, open label, multiple dose, long-term United States Phase II safety studies, EV-004 and EV-006, in which up to a total of four treatments were allowed over the course of one year. All three Phase III studies met their respective primary endpoints, EV-001 and EV-002 studies demonstrated superiority over placebo, and the EVB-003 study demonstrated non-inferiority to BOTOX and superiority over placebo. The EV-004 and EV-006 safety studies had no drug-related serious adverse events.
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