SAN DIEGO, CA, USA I September 8, 2015 I Neothetics, Inc. (NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2. The trials are evaluating LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. The Company expects to report top-line data by year-end.
“We are pleased to announce the last patient has been enrolled in the AbCONTOUR1 and AbCONTOUR2 trials. The enrollment was completed on schedule, and we are on track for data by end of this calendar year,” said George Mahaffey, President and Chief Executive Officer of Neothetics.
AbCONTOUR1 and AbCONTOUR2 are randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.40 mcg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled approximately 1,600 patients, which were randomized 1:1 to LIPO-202 or placebo. The trials are being conducted in approximately 80 sites across the U.S.
About LIPO-202
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ss2-adrenergic receptor agonist used in several FDA-approved drugs, including ADVAIR(R) for asthma. Neothetics’ studies suggest that salmeterol xinafoate also activates ss2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink by means of a natural process called lipolysis. LIPO-202 is being developed as a non-surgical, convenient method to reduce non-obese individuals’ central abdominal bulging due to subcutaneous fat — commonly characterized as a pot-belly, stomach rolls, or a pouch.
About Neothetics, Inc.
Neothetics is a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. The lead product candidate, LIPO-202, is for the reduction of subcutaneous fat in the central abdomen in non-obese patients, an indication for which there is no FDA-approved drug. If approved, LIPO-202 may be a best-in-class, non-surgical, non-ablative procedure and first-in-class injectable formulation for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.
Neothetics, LIPO-202, LIPO-102 and the Neothetics logo are trademarks or registered trademarks of Neothetics, Inc. Other names and brands may be claimed as the property of others.
SOURCE: Neothetics
Post Views: 93
SAN DIEGO, CA, USA I September 8, 2015 I Neothetics, Inc. (NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced completion of enrollment for its two pivotal U.S. Phase 3 trials titled AbCONTOUR1 and AbCONTOUR2. The trials are evaluating LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. The Company expects to report top-line data by year-end.
“We are pleased to announce the last patient has been enrolled in the AbCONTOUR1 and AbCONTOUR2 trials. The enrollment was completed on schedule, and we are on track for data by end of this calendar year,” said George Mahaffey, President and Chief Executive Officer of Neothetics.
AbCONTOUR1 and AbCONTOUR2 are randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.40 mcg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled approximately 1,600 patients, which were randomized 1:1 to LIPO-202 or placebo. The trials are being conducted in approximately 80 sites across the U.S.
About LIPO-202
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ss2-adrenergic receptor agonist used in several FDA-approved drugs, including ADVAIR(R) for asthma. Neothetics’ studies suggest that salmeterol xinafoate also activates ss2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells, causing them to shrink by means of a natural process called lipolysis. LIPO-202 is being developed as a non-surgical, convenient method to reduce non-obese individuals’ central abdominal bulging due to subcutaneous fat — commonly characterized as a pot-belly, stomach rolls, or a pouch.
About Neothetics, Inc.
Neothetics is a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market. The lead product candidate, LIPO-202, is for the reduction of subcutaneous fat in the central abdomen in non-obese patients, an indication for which there is no FDA-approved drug. If approved, LIPO-202 may be a best-in-class, non-surgical, non-ablative procedure and first-in-class injectable formulation for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.
Neothetics, LIPO-202, LIPO-102 and the Neothetics logo are trademarks or registered trademarks of Neothetics, Inc. Other names and brands may be claimed as the property of others.
SOURCE: Neothetics
Post Views: 93
