This is a supplemental safety study that Neothetics expects to submit to the US Food and Drug Administration (FDA) as part of the company’s New Drug Application package for LIPO-202, which the company anticipates filing in the second half of 2016.
LIPO-202 is an injectable formulation of salmeterol xinafoate, a well-known long-acting ß2-adrenergic receptor agonist used in asthma drugs. Research suggests 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.
The first drug in this emerging class, Kythera Biopharmaceuticals’ Kybella, scored FDA approval in late April. Kybella targets double chins via a different mechanism than LIPO-202. Allergan recently agreed to purchase Kythera Biopharmaceuticals.
The new safety study, dubbed LIPO-202-CL-23, is a double-blind extension study to evaluate the post-treatment safety and duration of the clinical effect of LIPO-202 in subjects who have completed either AbCONTOUR1 (LIPO-202-CL-18) or AbCONTOUR2 (LIPO-202-CL-19). The study is a safety study to evaluate the post-treatment safety profile of LIPO-202 for up to 1 year post-treatment. Secondarily, Neothetics will be evaluating post-treatment duration of clinical effect of LIPO-202.
Subjects will be evaluated for up to 1 year at 3-, 6-, 9-, and 12-month intervals from baseline (last visit of the parent study AbCONTOUR1 and AbCONTOUR2). All study subjects will be evaluated at 3 months for safety and duration of effect of LIPO-202. Only subjects with a clinically meaningful response, defined as a reduction of at least a 1-point change on the Patient-Global Abdominal Perception scale (P-GAPS) at the last visit of the parent study, will continue to be evaluated at 6, 9, and 12 months.