Profile: Evofem Biosciences Inc (EVFM.OQ)
19 Nov 2018
Evofem Biosciences Inc, formerly Neothetics, Inc., incorporated on February 1, 2007, is a clinical-stage specialty pharmaceutical company. The Company develops therapeutics. The Company focuses on localized fat reduction and body contouring. It focuses on the development of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese patients. The Company has completed Phase II development of LIPO-202. LIPO-202 is administered in a subcutaneous injection procedure that activates a natural metabolic process to shrink fat cells, without killing them, resulting in localized fat reduction, measurable results within four weeks and minimal risk with no downtime. The Company is also developing another product candidate, LIPO-102, an injectable form of a combination of salmeterol xinafoate and fluticasone propionate. LIPO-102 is indicated for the treatment of the orphan indication of symptomatic exophthalmos, or protrusion of the eye from the orbit, associated with thyroid-related eye disease caused by the expansion of fat and muscle behind the eye.
The LIPO-202 is an injectable formulation of the long-acting Beta2-adrenergic receptor agonist receptor agonist and salmeterol xinafoate, which is an active ingredient of FDA-approved inhaled products such as SEREVENT DISKUS, ADVAIR HFA and ADVAIR DISKUS. LIPO-202 can be administered by a physician or clinician in approximately five minutes in a specified number and defined placement of subcutaneous injections across the abdominal treatment area through a 30-gauge needle. Administering LIPO-202 evenly across the abdomen shrinks fat cells reduces central abdominal bulging due to subcutaneous fat. The Company completed a 513-patient, randomized, placebo-controlled, multi-center Phase II dose-ranging clinical trial, known as the RESET study, of LIPO-202. LIPO-102-CL-01 study is a single and multiple-dose Phase I safety and pharmacokinetics study. LIPO-102-CL-03 study provides information on the safety and efficacy of a range of doses of LIPO-102 administered through subcutaneous injection once or twice per week for four weeks to non-obese patients with measureable abdominal bulging. The Company focuses on LIPO-102-CL-04 and LIPO-102-CL-09 studies.
The VAL-CL-13 study is an exploratory study that compares magnetic resonance imaging (MRI) with external three-dimensional (3-D) digital stereophotogrammetry and a laser-guided manual tape measure procedure as objective physical measures of abdominal circumference. VAL-CL-24 study is a non-drug study, which includes approximately 40 subjects and explores two dimensional (2-D) ultrasound as a tool to measure subcutaneous fat thickness in the anterior abdomen, and determines the intra- and inter-rater reliability and retest reliability of 2-D ultrasound at its investigative clinical sites.
The Company's product candidate, LIPO-102, is indicated for the treatment of the orphan indication of symptomatic exophthalmos, or protrusion of the eye from the orbit, associated with thyroid-related eye disease caused by the expansion of fat and muscle behind the eye. The Company's preclinical studies demonstrate that the injection of salmeterol xinafoate into the back fat of minipigs reduces subcutaneous fat thickness as determined by 2-D ultrasound.
The Company competes with ZELTIQ Aesthetics, Inc., Erchonia Corporation, SculpSure, Valeant Pharmaceuticals International, Inc., Cutera, Inc. and Allergan plc.
Evofem Biosciences Inc
12400 High Bluff Dr Ste 600
SAN DIEGO CA 92130-3077