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.
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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.
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By GlobalDataDuring 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.
