Hesperos, a leader in emulating human biology for drug discovery, was awarded a $2 million research grant by the National Center for Advancing Translational Sciences (NCATS) in collaboration with the U.S. Food and Drug Administration (FDA). The goal of the effort is to develop an advanced testing platform capable of assessing the potency of the Botulinum Toxin (BoT) without the need for animal testing.
Botulinum Toxin is widely recognized for its clinical efficacy in treating various medical conditions such as muscle spasticity, strabismus, hyperactive urinary bladder, excessive sweating, and migraine, in addition to its cosmetic applications. Despite its therapeutic benefits, BoT is one of the most potent neurotoxins known to man, necessitating stringent batch testing to ensure consistent potency. Presently, the Mouse Lethal Bioassay (MLB) remains the most dependable method, tragically involving the sacrifice of over half a million animals annually.
Hesperos proposes to advance its human neuromuscular junction (NMJ) system for this critical application. The NMJ, where Botox exerts its effects by impeding the release of acetylcholine resulting in temporary muscle paralysis, serves as the focal point of their 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 first dose response curve for Botox in a human based system was published by one of the leads on the grant, Dr. J. Hickman. (Santhanam, et. al., Biomaterials 2018).
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. Following the establishment of this system, the FDA will undertake a rigorous qualification process, evaluating blinded samples to ensure the tool's accuracy and repeatability. Ultimately, the aim is to establish this technology as the new standard for ethically and safely evaluating Botulinum Toxin in the future.
FDA
The FDA is responsible for ensuring the safety, efficacy, and security of biological products in the United States. https://fda.gov
NCATS
The mission of National Center for Advancing Translational Sciences (NCATS) at NIH is to turn research observations into health solutions through translational science. https://ncats.nih.gov
Hesperos, Inc.
Hesperos is a global contract research organization (CRO) providing drug development services using its Human-on-a-Chip® platform - the most advanced, multi-organ microphysiological systems available today. https://hesperosinc.com
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Contacts
Nathan Post
npost@hesperosinc.com
407-900-5915
