Botulinum toxin(University of Texas Medical Branch)

May 03, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, today announced that the preliminary top-line results from its planned interim analysis of the Phase 2 trial with ABP-450 in the preventive treatment for chronic migraine did not meet the primary endpoint. The primary endpoint of mean reduction in monthly migraine days (MMD) over the period 13-24 weeks in a total of 325 analyzed patients randomized across three arms showed a reduction of 8.5 days in the 150 U arm and 7.7 days in the 195 U arm, compared with a reduction of 8.4 days in the placebo arm. These differences did not achieve statistical significance (p=0.9132 in 150 U arm; p=0.3611 in 195 U arm). The numerical reduction in MMDs were in the expected range for the two active arms, however, the reduction in the placebo arm was much higher than expected based on previous studies. In addition, none of the secondary endpoints met statistical significance. While the Company will continue to evaluate the complete dataset and determine the next steps in the development of ABP-450, it has immediately commenced cash preservation measures and will review all strategic options. “While we were surprised and disappointed that ABP-450 did not demonstrate statistically significant superiority over placebo in this interim readout, both active arms showed a reduction in monthly migraine days directly in-line with our expectations. We are conducting additional analyses of the interim data to understand the highly abnormal and unexpected placebo effect and further evaluate the results of this study to determine the best path forward in the development of ABP-450 for the preventive treatment of migraine,” said Marc Forth, President and Chief Executive Officer of AEON. “We want to express our gratitude to the patients who participated in this trial, the clinical investigators, and the AEON team for their hard work and dedication to this study.” AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, or the FDA, Health Canada and European Medicines Agency, or EMA. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. The content above comes from the network. if any infringement, please contact us to modify.

NEW YORK, April 3, 2024 /PRNewswire/ -- Nine million Americans have scoliosis; 90% of which presents during adolescence. A new clinical trial* demonstrates the efficacy of a unique, non-surgical treatment that quickly reduces curves that can become disabling. Lengthy, uncomfortable bracing and major spinal surgery (36,000 operations annually) can almost always be avoided with this new promising, anatomically-based, non-surgical approach that is a budding trend. Loren Fishman, MD, affiliated with Columbia University Medical School and medical director of Manhattan Physical Medicine and Rehabilitation, is the lead investigator of a ground-breaking clinical trial. In a controlled, randomized study of 24 patients, aged 12-20 years old, yoga plus small injections of botulinum toxin during one office visit successfully reduced spinal curves an average of 10 degrees in three weeks and 15 degrees in three months. Progress continued after the initial three-months. One fairly easy physical yoga-like maneuver, done briefly three times a day, was shown in earlier published research** to significantly reduce lumbar curves. That foundational research demonstrated that the physical maneuver strengthened the weak spinal muscles on the convex side, swiftly reducing the curve. In this new study, in addition to the physical maneuver strengthening the weak muscles, botulinum toxin relaxes the tight muscles on the concave side of the spine. Together, this physical maneuver plus botulinum toxin works significantly more effectively than the yoga-like maneuver alone to reverse scoliosis. Until now, embarrassing and difficult bracing and surgery have been the main treatments for 25-45 degree spinal curves. This new, successful muscle-balancing technique, offers hope to those who are handicapped by scoliosis. Dr. Fishman and a study participant are available for interview. * , includes 1-minute explanatory video by lead investigator Loren Fishman, MD ** Contact: Carol Ardman Manhattan Physical Medicine and Rehabilitation [email protected] Mobile: 917-856-6402 SOURCE Manhattan Physical Medicine and Rehabilitation