SAN DIEGO, CA, USA I December 14, 2015 I Neothetics, Inc. (NASDAQ:NEOT) today announced top-line results from its AbCONTOUR1 and AbCONTOUR2 U.S.-based pivotal Phase 3 trials to evaluate the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat. In both studies, LIPO-202 did not meet its co-primary composite and secondary endpoints. The co-primary endpoints were the proportion of subjects who reported an improvement of at least one point on the Patient-Global Abdominal Perception Scale (P-GAPS) and an improvement of at least two points on the Clinician Photonumeric Scale (CPnS) and the proportion of subjects who reported an improvement of at least two points on the P-GAPS and an improvement of at least two points on the CPnS. LIPO-202 continued to show a benign safety profile in these trials.
“We are disappointed by these unequivocally negative results. We expected LIPO-202 to demonstrate better efficacy based on the results we saw in the Phase 2b RESET trial. We would like to express our sincere gratitude to our investigators and patients who participated in this study,” said George Mahaffey, President and Chief Executive Officer of Neothetics. “We continue to analyze the data from AbCONTOUR1 and AbCONTOUR2 to fully understand the trial results and to evaluate our future plans.”
About AbCONTOUR1 and AbCONTOUR2
AbCONTOUR1 and AbCONTOUR2 were randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.4 mcg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled a total of 1,584 patients randomized 1:1 to LIPO-202 or placebo. The trials were conducted at approximately 80 clinical 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® 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 initially 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 the first-in-class injectable formulation, non-surgical, non-ablative procedure for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.
SOURCE: Neothetics
Post Views: 78
SAN DIEGO, CA, USA I December 14, 2015 I Neothetics, Inc. (NASDAQ:NEOT) today announced top-line results from its AbCONTOUR1 and AbCONTOUR2 U.S.-based pivotal Phase 3 trials to evaluate the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat. In both studies, LIPO-202 did not meet its co-primary composite and secondary endpoints. The co-primary endpoints were the proportion of subjects who reported an improvement of at least one point on the Patient-Global Abdominal Perception Scale (P-GAPS) and an improvement of at least two points on the Clinician Photonumeric Scale (CPnS) and the proportion of subjects who reported an improvement of at least two points on the P-GAPS and an improvement of at least two points on the CPnS. LIPO-202 continued to show a benign safety profile in these trials.
“We are disappointed by these unequivocally negative results. We expected LIPO-202 to demonstrate better efficacy based on the results we saw in the Phase 2b RESET trial. We would like to express our sincere gratitude to our investigators and patients who participated in this study,” said George Mahaffey, President and Chief Executive Officer of Neothetics. “We continue to analyze the data from AbCONTOUR1 and AbCONTOUR2 to fully understand the trial results and to evaluate our future plans.”
About AbCONTOUR1 and AbCONTOUR2
AbCONTOUR1 and AbCONTOUR2 were randomized, double-blind, placebo-controlled Phase 3 trials designed to assess the efficacy, safety, and tolerability of LIPO-202 (total weekly dose of 0.4 mcg for eight weeks) for the reduction of central abdominal bulging. The trials enrolled a total of 1,584 patients randomized 1:1 to LIPO-202 or placebo. The trials were conducted at approximately 80 clinical 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® 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 initially 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 the first-in-class injectable formulation, non-surgical, non-ablative procedure for localized fat reduction and body contouring. For more information on Neothetics, please visit www.neothetics.com.
SOURCE: Neothetics
Post Views: 78
