Initial research indicates that PerinelineTM, which received Orphan Drug Designation in 2022 may improve neuroplasticity and neuroregeneration to enable new synapses to be made. Pre-clinical data indicates that the therapy may improve mobility in both acute and chronic cases.
DUBLIN–(BUSINESS WIRE)–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 PerinelineTM to market.
Initial data from pre-clinical trials on PerinelineTM, developed by NeuroSolv Therapeutics, indicates 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 may improve both neuroplasticity and neuroregeneration.
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 grounding research of highly regarded neuro glyco scientist, Dr. Jessica Kwok, indicates that Perineline™, the new therapy developed by the NeuroSolv Therapeutics team may potentially improve mobility when administered at any point following injury. This would be a significant development in terms of spinal cord injury therapy. It would mean that the treatment could be given to acute as well as chronic cases of spinal cord injured patients, potentially even if it has been years since their initial injury.
The two-part treatment, an oral medication combined with neural signaling 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, PerinelineTM could be used to treat up to two million patients with spinal cord injuries worldwide. Data shared by the World Health Organization indicates that globally between 250,000 and 500,000 people are injured or diagnosed with a spinal cord injury each year. Within the UK alone, there are 50,000 people living with a life-changing spinal cord injury according to the Spinal Injury Association.
Economically, spinal cord injury has a massive cost impact on patients, families, and governments. The lifetime medical and care cost for spinal cord injury approaches $8 million per case.
The team behind the development of Perineline™ aim 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.
Aidan said: “There is a huge level of support and eagerness across the spinal cord injury community to advance recovery therapies. Our focus has been on finding the best way forward by developing a therapy that’s safe and positively impacts spinal cord patients in a way no therapy has been able to do thus far.”
NeuroSolv Therapeutics is working with AscellaHealth, a global specialty pharmacy and healthcare services provider focused on providing end-to-end solutions such as pre-commercialisation support, distribution, fulfilment and patient services to pharmaceutical manufacturers with products for rare disease and specialty conditions.
Craig Caceci, Managing Director at AscellaHealth EU/UK said: “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’re 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.”
Recent EMA Orphan Designation will enable regulatory acceleration across Europe, USA, UK and Japan to facilitate swift subsequent market authorisation and access to treatment in those markets for patients.
Investors or other parties interested in supporting the development of Perineline™ through clinical trials to bring the treatment to market, are invited to contact Aidan at NeuroSolv Therapeutics at aidan.lynch@neurosolvtherapeutics.com.
For further information, visit: www.neurosolvtherapeutics.com
About NeuroSolv Therapeutics
NeuroSolv Therapeutics is a Belfast, Northern Ireland and Baltimore, USA based ethical business which has developed and patented Perineline™ a two-part, non-surgical, therapy to resolve spinal cord injury based upon Neural Signaling Interventions and direct treatment of the Glial scar. The Glial scar is left in the spinal cord after injury, blocking the neural signals to the body. Perineline™ two-part treatment allows signals to travel through the treated zone thereby allowing function to return to the body and patient. Visit www.neurosolvtherapeutics.com for more information.
About AscellaHealth LLC
AscellaHealth, a global Healthcare & Specialty Pharmacy solutions company, serving patients, life sciences manufacturers, payers, and providers, offers a comprehensive portfolio of uniquely tailored, tech-enabled services supporting complex, chronic conditions or rare diseases that require specialty medications and/or cell and gene therapies. A recipient of numerous industry awards for innovation, and a National Association of Specialty Pharmacy Strategic Channel Partner of the Year award winner, AscellaHealth’s best-in-class, patient-centric approach is built upon proprietary technology processes for novel programmes and services to support the launch of specialty medications and proactively address multiple challenges, optimise clinical health outcomes, and improve quality of life for this patient population. AscellaHealth brings a rare and special perspective to all stakeholders. Visit www.ascellahealth.eu
Disclaimer of Endorsement: NeuroSolv and AscellaHealth neither endorse nor recommend any commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise. Any references on the NeuroSolv or AscellaHealth Websites; within media materials or downloaded from this site, does not necessarily constitute or imply an endorsement or recommendation by NeuroSolv or AscellaHealth.
Contacts
Marketing and Media enquiries
Gabriella Patone, Marketing Coordinator, AscellaHealth. Email: gabriella.patone@ascellahealth.com