SAN DIEGO, CA, USA I September 30, 2015 I Neothetics, Inc. (NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of the safety study, LIPO-202-CL-21, of LIPO-202, the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the U.S. Food and Drug Administration (FDA) as part of the company’s New Drug Application (NDA) package for LIPO-202, which the company anticipates filing in the second half of 2016.
“This study highlights the comprehensiveness of our clinical development program that supports our New Drug Application for LIPO-202, which is on track to be filed in the second half of 2016,” said Lincoln Krochmal, M.D., Chief Medical Officer for Neothetics. “While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently our data has shown that LIPO-202 has a safety profile equivalent to placebo.”
LIPO-202-CL-21 is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LIPO-202 in obese subjects (BMI>=30 kg/m2 but <=40 kg/m2). Approximately 120 subjects will be enrolled and randomized (in a 2:1 ratio) to one of two groups, LIPO-202 or placebo. Subjects will receive a course of treatment, which consists of 20 1-ml subcutaneous injections of LIPO-202 (total weekly dose of 0.40 mcg) once a week for eight weeks. The study is by protocol a safety study to evaluate the safety profile of LIPO-202 in obese subjects. Secondarily, Neothetics will be collecting efficacy data to evaluate the clinical effect of LIPO-202.
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.
SOURCE: Neothetics
Post Views: 472
SAN DIEGO, CA, USA I September 30, 2015 I Neothetics, Inc. (NEOT), a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, today announced the initiation of the safety study, LIPO-202-CL-21, of LIPO-202, the first non-invasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the U.S. Food and Drug Administration (FDA) as part of the company’s New Drug Application (NDA) package for LIPO-202, which the company anticipates filing in the second half of 2016.
“This study highlights the comprehensiveness of our clinical development program that supports our New Drug Application for LIPO-202, which is on track to be filed in the second half of 2016,” said Lincoln Krochmal, M.D., Chief Medical Officer for Neothetics. “While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently our data has shown that LIPO-202 has a safety profile equivalent to placebo.”
LIPO-202-CL-21 is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LIPO-202 in obese subjects (BMI>=30 kg/m2 but <=40 kg/m2). Approximately 120 subjects will be enrolled and randomized (in a 2:1 ratio) to one of two groups, LIPO-202 or placebo. Subjects will receive a course of treatment, which consists of 20 1-ml subcutaneous injections of LIPO-202 (total weekly dose of 0.40 mcg) once a week for eight weeks. The study is by protocol a safety study to evaluate the safety profile of LIPO-202 in obese subjects. Secondarily, Neothetics will be collecting efficacy data to evaluate the clinical effect of LIPO-202.
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.
SOURCE: Neothetics
Post Views: 472
