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.
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."
The 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.