US-based pharmaceutical firm Neothetics has started the post-treatment safety and duration of effect study, LIPO-202-CL-23, of the first non-invasive injectable drug candidate ‘LIPO-202’ to reduce central abdominal bulging due to subcutaneous fat in non-obese subjects.
LIPO-202 is an injectable formulation of salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist used in several FDA-approved drugs, including Advair for asthma.
The company intends to submit this supplemental safety study to the US Food and Drug Administration (FDA) as part of its new drug application (NDA) package for LIPO-202, in the second half of next year.
Neothetics chief medical officer Dr Lincoln Krochmal said: "The achievement of this milestone highlights the traction of our Phase III Pivotal Program, AbCONTOUR1 and AbCONTOUR2. "We are committed to develop LIPO-202 as the first non-invasive drug treatment for abdominal body contouring."
The double-blind extension LIPO-202-CL-23 trial will evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects who have completed either AbCONTOUR1 (LIPO-202-CL-18) or AbCONTOUR2 (LIPO-202-CL-19).
The trial is designed to assess the post-treatment safety profile of LIPO-202 for up to one year post-treatment. The company will also evaluate post-treatment duration of clinical effect of LIPO-202.
During the trial, subjects will be evaluated up to one year at three, six, nine, and twelve month intervals from baseline. For safety and duration of effect of LIPO-202, all study subjects will be evaluated at three months.
The company said that 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 six, nine, and twelve months.