Psilera, a biotechnology company with a focus on developing therapies for neurological disorders that are difficult to treat, and Hesperos, an industry leader in organ-on-a-chip technology, have announced a strategic agreement for the purpose of accelerating preclinical development of Psilera’s lead compound that targets frontotemporal dementia (1).
Targeting unmet needs
Key Takeaways
- Psilera and Hesperos have partnered to accelerate preclinical development of PSIL-006, a neuroplastogen candidate targeting frontotemporal dementia.
- Hesperos’ organ-on-a-chip system uses patient-derived stem cells to model disease physiology, supporting data generation for FDA submissions.
- FDA policy shifts promoting human-based lab models highlight organ-on-a-chip as a viable alternative to animal testing, aiding faster, safer drug development.
The compound, known as PSIL-006, integrates next-generation neuroplastogen, and the partnership with Hesperos will leverage that company’s advanced biological platform to develop a targeted treatment for unmet medical needs relating to frontotemporal dementia, a progressive neurological disorder for which treatment options are currently limited (1).
“Our collaboration with Hesperos represents a significant step forward in our mission to develop new treatments for neurodegenerative diseases,” said Chris Witowski, co-founder and CEO of Psilera, in a press release (1). “Utilizing their cutting-edge platform allows us to gain deeper insights into PSIL-006’s mechanism of action as we’re nearing first-in-human trials.”
The Hesperos platform, which integrates patient-derived induced pluripotent stem cells into interconnected, multi-organ systems, has been recognized for its ability to replicate human physiological responses, according to Hesperos, and has successfully supported multiple FDA Investigational New Drug and Orphan Drug Designation applications (1).
“We are excited to partner with Psilera as they advance next-generation neuroplastogens to potentially treat a range of hard-to-treat diseases,” said James Hickman, PhD, co-founder and chief scientist at Hesperos, in the press release (1). “Our platform offers a unique opportunity to assess the compound’s effects on neural tissues derived from patients with neurodegeneration, potentially accelerating the development of a much-needed therapy utilizing clinically relevant functional readouts.”
Prevalence of organ-on-a-chip
Organ-on-a-chip technology was at the center of another partnership, announced in April 2025, between provider CN Bio and China-based R&D company Pharmaron (2). Under that agreement, Pharmaron is tasked with validating CN Bio’s PhysioMimix technology across existing applications, while integrating organ-on-a-chip technologies into its R&D platform. Also in the deal, the partners agreed to explore potential new applications that would address unmet needs in drug discovery and development (3).
Also in April 2025, organ-on-a-chip was mentioned as one of the human-based lab models that FDA would be shifting to, specifically those systems that mimic the heart and liver, in its objective to reduce and eventually replace animal testing in monoclonal antibody safety evaluations (4).
“For patients, it means a more efficient pipeline for novel treatments,” FDA Commissioner Marty Makary, PhD, said at the time (4). “It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.”
In the press release announcing the agreement between Hesperos and Psilera, that policy adjustment by FDA was cited as a means of promoting the benefits of organ-on-a-chip—for not only reducing the reliance on animal testing, but also enabling precise evaluation of drug efficacy and safety that has the potential to expedite clinic-ready datasets (1).
References
1. Hesperos. Psilera Collaborates with Drug Development Leader Hesperos to Advance Preclinical Modeling of PSIL-006 for Frontotemporal Dementia. Press Release. June 9, 2025.
2. CN Bio. CN Bio and Pharmaron Establish Long-Term Strategic Partnership to Develop OOC Technologies on a Global R&D Platform. Press Release. April 24, 2025.
3. Mirasol, F. CN Bio and Pharmaron Partner to Develop OOC Technologies for Global R&D. BioPharmInternational.com, April 26, 2025.
4. FDA. FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. Press Release. April 10, 2025.