SAN DIEGO, Sept. 30, 2013 (GLOBE NEWSWIRE) -- Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, today announced positive results from its Phase 2b RESET clinical study of LIPO-202 (Salmeterol Xinafoate for Injection). The lead product candidate, LIPO-202, is a novel, physician-administered, injectable pharmaceutical product designed to produce localized flattening of the abdominal treatment area through the non-ablative reduction of subcutaneous fat.
RESET was a 513-patient, multi-center, randomized, placebo-controlled Phase 2 clinical trial designed to measure safety and efficacy of three different doses of LIPO-202 (0.4, 1.0 and 4.0 micrograms (total dose)) in healthy, non-obese subjects with abdominal bulging due to excess subcutaneous fat. Patients received twenty 1 mL subcutaneous injections of LIPO-202 or placebo into a defined abdominal treatment area (~400 cm2) once per week for eight weeks. Trial endpoints included qualitative and quantitative measures of abdominal bulging (contour), as well as the collection of standard safety information.
LIPO-202 showed excellent safety and tolerability at all doses in RESET. Adverse events with LIPO-202 were generally mild and transient and did not differ in incidence or severity across all doses tested compared to placebo; the most common adverse effects were injection site reactions that could be attributed to the injection procedure rather than drug treatment. Ninety-two percent of patients completed the RESET trial per protocol and no patient withdrew due to an adverse effect. In terms of efficacy assessments, the 0.4 microgram total dose (20 x 0.02 microgram/mL) was identified as optimal. Responder analyses using a composite endpoint of a patient self-assessment (5-point verbal Patient Global Abdominal Profile Scale – P-GAPS) plus a clinician rating of abdominal contour (6-point visual Clinician Photo-numeric Scale – CPnS) demonstrated significant efficacy of LIPO-202 at the 0.4 microgram dose versus placebo (p<0.05) in RESET. Significant efficacy was demonstrated with this composite endpoint using both a clinically meaningful 1-point improvement on the P-GAPS or a much higher hurdle of a 2-point improvement on the P-GAPS, both in combination with a 2-point improvement on the CPnS. Patients treated with 0.4 micrograms of LIPO-202 also reported an average of a 2-point improvement on a 7-point satisfaction rating scale. Moreover, patients in this treatment group showed a mean reduction in circumference at the umbilicus of 1.6 cm (versus 0.65 cm for placebo; p=0.001) using a laser-guided manual tape measurement technique. The average reduction in abdominal volume in the treatment zone was 192 cc for the 0.4 microgram LIPO-202 dose versus 68 cc for placebo (p=0.002). Treatment effects were enhanced in the subgroup of patients who remained weight neutral or who lost weight during the nine week trial, consistent with the target patient population for LIPO-202 (non-obese patients who maintain a stable weight and lifestyle and who seek abdominal flattening). For example, the mean reduction in abdominal circumference and volume in the treatment area was 2.7 cm (p<0.001) and 329 cc (p<0.001), respectively, for the 0.4 microgram LIPO-202 dose.
"Results from our RESET trial were consistent with our previous clinical trials, reaffirming our strong confidence in the safety and efficacy of LIPO-202 as an aesthetic treatment to flatten the abdomen," said George Mahaffey, President and CEO of Lithera. "Importantly, RESET has confirmed the optimal dose of LIPO-202 and provided important insights into selecting the proper tools for measuring drug effect. Improvements in abdominal contour with LIPO-202 can be seen within four weeks of treatment and the vast majority of our subjects report no LIPO-202 adverse events. These data, combined with our prior trial results, encourage us to approach FDA for meaningful discussions about next steps to advance our program."
For more information on the Phase 2b trial of LIPO-202, including specific patient inclusion and exclusion criteria, please visit www.clinicaltrials.gov.
Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both lifestyle and medical indications in aesthetic medicine and ophthalmology. Using FDA-registered drugs approved for use in other indications, Lithera's products target and stimulate natural fat tissue metabolism to achieve non-ablative, non-surgical fat tissue reduction in specific locations. Our lead product candidate, LIPO-202 (Salmeterol Xinafoate for Injection), is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). LIPO-202 is currently under development for the aesthetic reduction of bulging in the periumbilical area due to excess subcutaneous fat. LIPO-102 (Salmeterol Xinafoate and Fluticasone Propionate for Injection) is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (also known as Graves' Orbitopathy). Founded in 2007, the Company has assembled an exceptional team of senior executives, employees and advisors and has been financed by top-tier venture capital firms. For more information on Lithera, Inc., please visit www.lithera.com.
Lithera, LIPO-102, LIPO-202 and the Lithera logo are trademarks or registered trademarks of Lithera, Inc. Other names and brands may be claimed as the property of others.