Periodic Reporting for period 1 - HydroLieve (A long-lasting non-migrating hydrogel for relieving chronic pain)
Okres sprawozdawczy: 2018-08-01 do 2020-12-31
Chronic Neuropathic Pain (NeP) is an enormous problem globally. Estimates predicate that 20% of adults suffer from pain world-wide and 10% are newly diagnosed with chronic pain annually1. According to the EuroPain Innovative Medicines Initiative (IMI)2, one in five adults in Europe suffers from chronic pain. One type of neuropathic pain that is particularly detrimental to patients quality of life is Trigeminal Neuralgia (TN). The trigeminal nerve is responsible for facial sensory function, and trauma to this nerve can result in sudden, severe, stabbing and recurrent episodes of pain. Patients with TN experience a prolonged debilitating condition, where the pain is often described as one of the most painful conditions in medicine. Epidemiologists estimated the prevalence of chronic TN pain is also large at 7%3, which amounts to 36 million Europeans. Similarly, in the US, the American Association of Neurological Surgeons report that 150,000 people are diagnosed with TN every year with a prevalence of chronic TN impacting 1.7 % of population 4.
Drug therapy is the current first line of treatment for TN. If drug therapy fails, then surgery is performed. Existing drug therapy include Anti-seizure drugs (Carbamazepine, Clonazepam, Oxcarbazepine, Phenytoin). Current surgical therapy approaches include Percutaneous stereotactic rhizotomy (PSR), Percutaneous glycerol rhizotomy (PGR), Gamma knife surgery (GKS), Balloon compression, Radiofrequency thermal lesioning, Microvascular decompression (MVD) and Neurectomy. Based on the limitations with the current treatments for TN, it is clear there is a strong market and clinical need for new therapies that: do not result in permanent nerve damage; give long lasting pain relief (greater than 12 months) and are minimally invasive with no risk of nerve damage.
Within the Hydrolieve project, develop and evaluate a novel hydrogel to treat chronic TN. Novel formulation gives a much more effective and longer lasting treatment for chronic pain. The chemically-modified hydrogel proposed contains positively charged neurotoxin molecules, which are attracted to the negatively charged carboxylate groups in the ion-nerve channel openings. In clinical use, the hydrogel will be injected into the target area of the nerve and will block the sodium ion channels of the nerve cell, thereby preventing the entry of sodium ions into the intracellular space. Since the flow of sodium ions into nerve cells is a necessary step for nerve conduction, the hydrogel will effectively block all pain signals from the nerve.
In the course of the 12 month project; the team have met a number of key milestones to progress the development of the technology, namely:
Milestone 1: Tested Hydrogel prototype in an acute in vivo study. This study involved testing the gel in an neuropathic pain model and the results demonstrated that the gel can reduce pain sensations by 40% compared to the control group.
Milestone 2: Filed an European patent filing (EP# EP20187552.3) via NUI Galway TTO. All patent claims are supported with in vitro and in vivo data.
Milestone 3: Built a company team for a spin out, company team includes top KOLs (Dr Pete Schmidt, Stanford Pain Centre) and former senior company executives (Mr Damien Kelly, former CFO of Mylan Pharmaceuticals). The team are in negotiations with numerous venture capitalists to secure private funding and spin out the technology from NUI Galway. Also applied for an EIC Blended equity grant on the technology (Submission date June 2021).
To progress this technology from the lab and into a clinical setting, a commercial pathway is required. Therefore, the project team have developed a detailed business plan and funding requirements document detailing the market opportunity, the competitive landscape and USP of Hydrolieve technology, the regulatory pathway and reimbursement status. The team are now applying for SME European Funding (EIC accelerator) and meeting potential investors and licensees for the technology, in order to accelerate the path to market and clinic.
Drug therapy is the current first line of treatment for TN. If drug therapy fails, then surgery is performed. Existing drug therapy include Anti-seizure drugs (Carbamazepine, Clonazepam, Oxcarbazepine, Phenytoin). Current surgical therapy approaches include Percutaneous stereotactic rhizotomy (PSR), Percutaneous glycerol rhizotomy (PGR), Gamma knife surgery (GKS), Balloon compression, Radiofrequency thermal lesioning, Microvascular decompression (MVD) and Neurectomy. Based on the limitations with the current treatments for TN, it is clear there is a strong market and clinical need for new therapies that: do not result in permanent nerve damage; give long lasting pain relief (greater than 12 months) and are minimally invasive with no risk of nerve damage.
Within the Hydrolieve project, develop and evaluate a novel hydrogel to treat chronic TN. Novel formulation gives a much more effective and longer lasting treatment for chronic pain. The chemically-modified hydrogel proposed contains positively charged neurotoxin molecules, which are attracted to the negatively charged carboxylate groups in the ion-nerve channel openings. In clinical use, the hydrogel will be injected into the target area of the nerve and will block the sodium ion channels of the nerve cell, thereby preventing the entry of sodium ions into the intracellular space. Since the flow of sodium ions into nerve cells is a necessary step for nerve conduction, the hydrogel will effectively block all pain signals from the nerve.
In the course of the 12 month project; the team have met a number of key milestones to progress the development of the technology, namely:
Milestone 1: Tested Hydrogel prototype in an acute in vivo study. This study involved testing the gel in an neuropathic pain model and the results demonstrated that the gel can reduce pain sensations by 40% compared to the control group.
Milestone 2: Filed an European patent filing (EP# EP20187552.3) via NUI Galway TTO. All patent claims are supported with in vitro and in vivo data.
Milestone 3: Built a company team for a spin out, company team includes top KOLs (Dr Pete Schmidt, Stanford Pain Centre) and former senior company executives (Mr Damien Kelly, former CFO of Mylan Pharmaceuticals). The team are in negotiations with numerous venture capitalists to secure private funding and spin out the technology from NUI Galway. Also applied for an EIC Blended equity grant on the technology (Submission date June 2021).
To progress this technology from the lab and into a clinical setting, a commercial pathway is required. Therefore, the project team have developed a detailed business plan and funding requirements document detailing the market opportunity, the competitive landscape and USP of Hydrolieve technology, the regulatory pathway and reimbursement status. The team are now applying for SME European Funding (EIC accelerator) and meeting potential investors and licensees for the technology, in order to accelerate the path to market and clinic.