Topline Data Expected in Third Quarter 2013 as First Patient Is Treated in 500-Patient "RESET" Trial
SAN DIEGO, CA, USA I March 12, 2013 I Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, announced today that the first patient has been treated with LIPO-202 (Salmeterol Xinafoate for Injection) in its 500-patient Phase 2b "RESET" trial. LIPO-202, Lithera’s lead product candidate, is a novel injectable pharmaceutical product designed to produce localized reduction of subcutaneous fat.
"Initiating the RESET trial is a significant milestone for Lithera and in the development of LIPO-202 as a non-ablative treatment for the aesthetic reduction of subcutaneous abdominal fat," stated George W. Mahaffey, President and CEO of Lithera. "Following our recent Series C financing, Lithera is focused on advancing LIPO-202 in the clinic as we see tremendous potential for the drug to address a significant opportunity in aesthetic medicine – the ability to offer a quick and minimally invasive ‘lunch time’ procedure with no patient down time that effectively reduces abdominal fat."
RESET is a 500-patient, multi-center, randomized, placebo-controlled clinical trial designed to measure the effects of three different doses of LIPO-202, compared to placebo, on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects. Patients randomized into each of the four trial arms will receive subcutaneous injections spaced evenly across the abdomen once per week for eight weeks. Trial endpoints include multiple qualitative and quantitative measures of bulge reduction, as well as key safety information.
"The RESET trial incorporates indication-specific objective and subjective efficacy measures, as well as a suitably large sample size in order to provide what we hope to be a very clear demonstration of LIPO-202’s effectiveness and a definition of its optimal dose," remarked Murray C. Maytom, MBChB, Chief Medical Officer of Lithera. "Despite the trial’s size, we expect top-line results in the third quarter of 2013 due to the short treatment duration and time to response, historically rapid trial enrollment, as well as strong interest from clinicians and patients in trial participation."
For more information on the Phase 2b trial of LIPO-202, including specific patient inclusion and exclusion criteria, please visit www.clinicaltrials.gov
About Lithera:
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 subcutaneous fat in the periumbilical area. 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 (the thyroid condition is also known as Graves’ Disease). 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.
SOURCE: Lithera
Post Views: 116
Topline Data Expected in Third Quarter 2013 as First Patient Is Treated in 500-Patient "RESET" Trial
SAN DIEGO, CA, USA I March 12, 2013 I Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, announced today that the first patient has been treated with LIPO-202 (Salmeterol Xinafoate for Injection) in its 500-patient Phase 2b "RESET" trial. LIPO-202, Lithera’s lead product candidate, is a novel injectable pharmaceutical product designed to produce localized reduction of subcutaneous fat.
"Initiating the RESET trial is a significant milestone for Lithera and in the development of LIPO-202 as a non-ablative treatment for the aesthetic reduction of subcutaneous abdominal fat," stated George W. Mahaffey, President and CEO of Lithera. "Following our recent Series C financing, Lithera is focused on advancing LIPO-202 in the clinic as we see tremendous potential for the drug to address a significant opportunity in aesthetic medicine – the ability to offer a quick and minimally invasive ‘lunch time’ procedure with no patient down time that effectively reduces abdominal fat."
RESET is a 500-patient, multi-center, randomized, placebo-controlled clinical trial designed to measure the effects of three different doses of LIPO-202, compared to placebo, on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects. Patients randomized into each of the four trial arms will receive subcutaneous injections spaced evenly across the abdomen once per week for eight weeks. Trial endpoints include multiple qualitative and quantitative measures of bulge reduction, as well as key safety information.
"The RESET trial incorporates indication-specific objective and subjective efficacy measures, as well as a suitably large sample size in order to provide what we hope to be a very clear demonstration of LIPO-202’s effectiveness and a definition of its optimal dose," remarked Murray C. Maytom, MBChB, Chief Medical Officer of Lithera. "Despite the trial’s size, we expect top-line results in the third quarter of 2013 due to the short treatment duration and time to response, historically rapid trial enrollment, as well as strong interest from clinicians and patients in trial participation."
For more information on the Phase 2b trial of LIPO-202, including specific patient inclusion and exclusion criteria, please visit www.clinicaltrials.gov
About Lithera:
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 subcutaneous fat in the periumbilical area. 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 (the thyroid condition is also known as Graves’ Disease). 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.
SOURCE: Lithera
Post Views: 116
