Curi Bio announced the signing of a Memorandum of Understanding (MOU) for scientific and strategic collaboration with Genetox and DreamCIS. Genetox and DreamCIS will collaborate with Curi Bio to use the company?s cutting-edge neuromuscular junction (NMJ) model as a non-animal potency assay for advancing Genetox?s BOTAONE (botulinum toxin) through US FDA approval. BoT is renowned for its therapeutic applications, including the treatment of chronic pain, autonomic disorders, congenital neuromuscular conditions, and cosmetic enhancements.

Accurate potency assessment of manufactured lots is essential for safe and effective dosing of the potent neurotoxin. Current standards utilize the mouse lethality bioassay, which is slow, costly, and controversial. US lawmakers recently passed the FDA Modernization Act 2.0 which removed the animal testing regulatory mandate for new investigational drug applications.

As an industry leader in delivering human functional data using its advanced platforms for global pharmaceutical and biotechnology companies, Curi Bio has already completed multiple projects that have displaced the use of many animal studies for the discovery of next-generation medicines. Shortly after the bill?s passage, Curi Bio was awarded a Small Business Innovation Research grant to develop a novel human stem-cell based neuromuscular junction. The project has supported Curi Bio?s development of a next-generation 3D human neuromuscular junction model used for disease modeling, for pharmaceutical and cosmetics potency assays, and for testing broad pathogenicity.

The project is currently underway in collaboration with Dr. Alec Smith and Dr. David Mack at the University of Washington and has the goal of delivering human data for animal-free functional potency assays. The project will deliver a functional potency assay for botox research and manufacture in a turnkey, scalable format. Once developed, the assay could be further extended towards a variety of devastating human neuromuscular diseases such as amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth disease (CMT).

The project was awarded to Curi Bio by the National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS) in conjunction with the Food and Drug Administration (FDA). With this MOU, Genetox shows its commitment to making Curi Bio?s NMJ-based potency assay a key part of BOTAONE?s manufacturing, quality control, and product release processes. Genetox will seek approval for its BOTAONE product from regulatory authorities, including the Korean FDA and United States FDA.

This MOU represents an innovative advancement in the field of botox production and regulatory acceptance and marks the first steps of a paradigm shift where in vitro human functional data are used for regulatory approval. As the biopharmaceutical industry shifts towards non-animal testing methodologies, this joint effort underscores the commitment of the three companies to innovation and to ethical research practices.