US-based pharmaceutical firm Neothetics has started two pivotal US Phase III trials AbCONTOUR1 and AbCONTOUR2 of its first non-invasive injectable drug candidate, LIPO-202, for reducing 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 many FDA-approved drugs, including Advair for asthma.
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Both the randomised, double-blind, placebo-controlled Phase III trials are designed to evaluate the efficacy, safety and tolerability of LIPO-202 (total weekly dose of 0.40mcg for eight weeks) for the reduction of central abdominal bulging.
A total of 1,600 patients will be enrolled in these trials, which are scheduled to be conducted at around 80 sites across the US, and these patients will be randomised 1:1 to LIPO-202 or placebo.
Neothetics chief medical officer Dr Lincoln Krochmal said: "The design of the AbCONTOUR trials is based upon our Phase II RESET trial, which showed meaningful and consistent efficacy and safety for LIPO-202 for reducing central abdominal bulging.
"Past studies also demonstrate LIPO-202 has an excellent safety profile, similar to placebo in nearly 800 subjects treated to date. These factors give us confidence as we start our pivotal Phase III trials."
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By GlobalDataThe primary efficacy endpoint of both the trials is measured using two independent assessment scales the Patient-Global Abdominal Perception Scale (P-GAPS) and the Clinician Photonumeric Scale (CPnS).
Developed and validated by Neothetics, these two assessment scales were used successfully in the previously reported 513-patient Phase II RESET study of LIPO-202.
These scales will be used together as a composite to define a responder as a patient who achieves a two point or greater change on both the P-GAPS and the CPnS.
Secondary endpoints in these trials include the reduction in abdominal circumference from baseline using laser-guided manual tape and the subjects’ overall satisfaction of the improvement of their appearance as assessed with an Abdominal Contour Questionnaire.
