In partnership with AscellaHealth, NeuroSolv Therapeutics is seeking to expand the clinical trial development programme and accelerate regulatory approval procedures to optimise the prospect of bringing Perineline—a novel spinal cord injury therapy—to market.
Initial data from preclinical trials on Perineline, developed by NeuroSolv, indicate that it may improve mobility, and be used in both chronic and acute cases. The non-surgical medical therapy, which has attained European Medicines Agency (EMA) orphan designation, has a proposed mechanism of action that could enhance both neuroplasticity and neuroregeneration.
As per a company press release, by temporarily removing the protective perineuronal net on the surface of spinal cord neurons, new synapses can be created. When combined with rehabilitation techniques, this process enables new connections to be made to enable functional recovery. In addition, the treatment removes signal-blocking glial scars on the surface of spinal cord neurons to enable new synapses to be made.
The research of neuro-glycoscientist Jessica Kwok (University of Leeds, Leeds, UK) indicates that Perineline may potentially improve mobility when administered at any point following injury. This would be a “significant development” in terms of spinal cord injury therapy, the release adds, and would mean that the treatment could be given to patients with acute as well as chronic cases of spinal cord injury—potentially even if it has been years since their initial injury.
The two-part treatment—an oral medication combined with neural signalling interventions—is well tolerated and does not require injections, surgery, or implants. The treatment is about to undergo clinical trials and, if regulatory approval is obtained, Perineline could be used to treat up to two million patients with spinal cord injuries worldwide.
The team behind the development of Perineline aims to raise awareness of the significant impact it could have on the lives of people with spinal cord injury and attract interest from investors, patients, and other stakeholders, to progress on to clinical trial stage. The team is also looking to partner with spinal cord injury associations and sports injury organisations to bring awareness to advancements in treatments.
Joint founders, father and son team Aidan and Ros Lynch, have spent years pioneering research into spinal cord injury treatment after Ros, then 20, suffered a life-changing spinal injury in 2015 that left him paralysed from the chest down—requiring surgery and ventilation. He remained hospitalised and in intensive care for a year.
“There is a huge level of support and eagerness across the spinal cord injury community to advance recovery therapies,” said Aidan Lynch. “Our focus has been on finding the best way forward by developing a therapy that is safe and positively impacts spinal cord patients in a way no therapy has been able to do thus far.”
Craig Caceci, managing director at AscellaHealth EU/UK, added: “When we first started collaborating with the team developing Perineline, it was immediately clear that this new therapeutic option could potentially be incredibly significant, in terms of its potential to positively impact the mobility outcomes for hundreds of thousands of people living with spinal cord injury worldwide. We are proud to partner with NeuroSolv Therapeutics to support the clinical development for this promising therapy with the goal of delivering improved mobility and quality of life for spinal cord patients.”