Research Grant Supports Animal-Free Testing for Botox

The National Center for Advancing Translational Services (NCATS) and the US Food and Drug Administration (FDA) awarded a $2 million research grant to develop an advanced testing platform capable of assessing the potency of botulinum toxin without the need for animal testing, according to a press release.

The grant was awarded to Hesperos, which proposes to advance its human neuromuscular junction (NMJ) system for this critical application. Presently, the Mouse Lethal Bioassay (MLB) remains the most dependable method for the stringent batch testing necessary for ensuring consistent potency of botulinum toxin.

The NJM, where botox exerts its effects by impeding the release of acetylcholine, resulting in temporary muscle paralysis, is the focal point of the research. “Leveraging human induced pluripotent stem cells (iPSCs), researchers at Hesperos reproduce a functional NMJ where motor neurons interact with skeletal muscle tissue, accurately replicating human physiological responses,” the press release says. “By successfully developing a high-throughput, human-based platform, Hesperos endeavors to obviate the need for animal testing in this process while simultaneously enhancing the safety profile of BoT.”