Public Funding for Neurone Limited

Neurone Ltd is a UK-based pharmaceutical development SME with a core project team of Adam George (CEO/former joint head of R&D at GW Pharmaceuticals), Dr Christopher Hayes (Intellectual Property lawyer) and Dean Putt (COO/Controlled drug specialist). Despite the availability of 30 approved epilepsy pharmaceuticals, the proportion of refractory epilepsy patients i.e. those who are unable to achieve control of their seizures remains static at circa 30%, equating to 15m patients globally. Several molecules from the Cannabis plant have been shown to have therapeutic potential in epilepsy. Our team were previously involved in the successful development of an FDA and MHRA approved epilepsy treatment manufactured from Cannabidiol extracted from cannabis plants and purified. This is on track to become a blockbuster drug in 2024 (annualised revenues over $1bn) but due to limitations of its IP protection it's approved commercial label and insurer reimbursement remains restricted to three relatively rare, orphan epilepsy syndromes. We are working to design, manufacture and develop an improved, plant-extract based, cannabinoid containing epilepsy treatment, with botanical complexity based IP protection that will enable a much broader commercial opportunity, and ability to benefit a much broader range of patients with intractable epilepsy. For many years the UK Home Office has been under pressure by parents of children with severe refractory epilepsies to allow import and prescribing of uncontrolled, non-pharmaceutical cannabis extracts. Whilst this compassionate access has been allowed, the volume of prescribing remains low. NICE has called for further clinical research to be conducted to demonstrate the safety and efficacy of such products. Granted our Controlled drug license by UK Home Office in March 2024, we propose to develop a pharmaceutical product capable of meeting MHRA's quality requirements for approval as a pharmaceutical product that can be properly prescribed, enabling patient access and potential NHS and international reimbursement.