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after that Long pauseinvestment is flowing in again Brain Drug ResearchM&A deals centered around central nervous system prospects were the second most popular in 2023, behind oncology, the research firm said. IQVIA Report.
But despite growing enthusiasm for developing new drugs to treat neurological disorders such as epilepsy, Alzheimer’s and Parkinson’s, the majority of investigational drugs have yet to reach the development stage, and 92% have failed in human trials.
“Neuro has one of the highest failure rates and highest investment rates, which means something is wrong,” said Arif Saleh, CEO of Axosim, a Louisiana-based biotechnology company that has a brain-chip platform.
Not only are the scientific hurdles in brain research higher than in other fields, but most early-stage testing for toxicity and efficacy is done in animals whose brains don’t match the complexity of the human brain, he said.
of FDA Modernization Act 2.0 The need for preclinical trials to gain drug approval has been eliminated, making it possible to move away from animal models. This has now opened the door to computer modeling, AI-Driven Testing and Organ Chip Options like AxoSim are available. Other companies in this growing preclinical testing space include Hesperos and emulateUsing organ-on-a-chip technology, Curis AIThe company has a bio AI clinical prediction platform.
A brain on a chip
Saleh joined AxoSim in June to help commercialize its brain chip technology. 3D Human Brain Organoids To test medicines for safety and effectiveness.
2023, AxoSim Acquired Vyant Bio’s subsidiary StemoniX’s microBrain drug discovery technology platform for neurological diseases. $2.25 million deal “This technology adds to the company’s suite of technologies, including AxoSim’s NerveSim and BrainSim platforms, enabling AxoSim to have broad application in diseases of the central and peripheral nervous system,” Saleh said.
“The aim is to accelerate adoption within the pharmaceutical industry and to standardize the platform’s tools to make them easier to use.”
He said the company’s specialization in brain-related technologies gives it a strategic advantage over its competitors.
“Most companies target multiple organs: lungs, heart, brain,” Saleh said. “What I’ve learned in my 15-year career providing tools and platforms to the pharmaceutical industry is that you need to focus on one disease area.”
He said his company’s platform provides actual measurements rather than predictions, which could give it an advantage over platforms that use computer modeling. study The AxoSim technology achieved better specificity than the animal model (93% vs. 30%), but the animal model was superior in sensitivity (75% vs. 53%).
Pharmaceutical company participation
AxoSim leaders are now focused on rolling out their technology to more businesses.
“The key is to drive pharma adoption, standardize the tools on the platform so they’re easy to use, so they can launch quickly, scale quickly and get more customers using them,” Saleh said.
AxoSim has already got several major industry players on board with the platform, but has not yet disclosed who its partners are.
“The pharmaceutical industry is always going to try to dabble, but we’re past the stage where some companies are trying to dabble,” he said.
While the AxoSim platform currently only tests for toxicity and efficacy, Saleh said the plan is to also measure the effects of drugs on other brain functions, such as memory and learning.
“If we can get that sorted we will be in a pretty good position commercially,” he said.
