Coretox (botulinum toxin type A) / Medytox - LARVOL DELTA

Complexing Protein-Free Botulinum Neurotoxin A Formulations: Implications of Excipients for Immunogenicity. (PubMed, Toxins (Basel)) - "Reportedly, the rate of antibody-mediated secondary non-response is lowest in complexing protein-free (CF) IncobotulinumtoxinA (INCO). Here, the published data and literature on the composition and properties of the three commercially available CF-BoNT/A formulations, namely, INCO, Coretox® (CORE), and DaxibotulinumtoxinA (DAXI), are reviewed to elucidate the implications for their potential immunogenicity...Presently, no data are available on the immunogenicity of CORE in human beings. It remains to be seen whether all three CF BoNT/A formulations demonstrate the same low immunogenicity in patients over a long period of time."

Journal • Review

Free of Complexing Proteins – Enough for Low Immunogenicity of Botulinum Neurotoxin Formulations? A Comparison of Excipients (TOXINS 2024) - "Results Presently, incobotulinumtoxinA, daxibotulinumtoxinA, and Coretox® are 3 commercially available BoNT-A formulations that are free of clostridial complexing proteins. Results from early clinical studies show antibodies against BoNT-A and RTP004 at low frequencies; however, the follow-up period is critically short, with a maximum of 3 injections.7 For Coretox, there are presently no data on the formulation’s immunogenicity in human beings. It remains to be seen whether all 3 CF-BoNT-A formulations show the same low immunogenicity in patients over a long period of time."

Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial. (PubMed, Medicine (Baltimore)) - "The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment."

Clinical • Journal • P1 data • Cardiovascular • Movement Disorders

Comparative Pharmacodynamics of Three Different Botulinum Toxin Type A Preparations following Repeated Intramuscular Administration in Mice. (PubMed, Toxins (Basel)) - "Herein, we compared the pharmacodynamics of three BoNT/A formulations, i.e., Botox (onabotulinumtoxinA), Xeomin (incobotulinumtoxinA), and Coretox, following repeated intramuscular (IM) injections in mice. Among the three BoNT/A formulations, only Coretox afforded a significant increase in paretic effects and chemodenervation with a prolonged duration of action after repeated injections. These findings suggest that Coretox may offer a better overall therapeutic performance in clinical settings."

Journal • PK/PD data • Preclinical • Movement Disorders

CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1) (clinicaltrials.gov) - P1; N=30; Completed; Sponsor: Medy-Tox

Clinical • New P1 trial • Cardiovascular • Movement Disorders • Muscle Spasticity

Safety verification for polysorbate 20, pharmaceutical excipient for intramuscular administration, in Sprague-Dawley rats and New Zealand White rabbits. (PubMed, PLoS One) - "For those reasons, newly developed BoNT/A products (CORETOX®, Medytox, Inc., Republic of Korea) contained polysorbate 20, a non-human-derived excipient, to replace the HSA...The current study suggested that intramuscular administration of polysorbate 20 was considered to be safe at a level similar to that of HSA, which has an in vivo safety profile accumulated over the years. This provided the basis for the in vivo safety profile of polysorbate 20 administered intramuscularly and the scientific reliability of the use of polysorbate 20 as an alternative to HSA, which is used as an excipient for various pharmaceuticals in terms of its safety."

Journal • Preclinical • Allergy • Hematological Disorders