Adult Drug Resistant mesial Temporal Lobe Epilepsy (drTLE)

The partial epilepsy form of mesial Temporal Lobe Epilepsy (mTLE) is the most frequent form of human epilepsy and usually up to 70% of patients can be controlled through intake of up to two anti-epileptic drugs (AEDs). Nevertheless, in the US there are approximately 190,000 while in the EU up to 260,000 drug-resistant patients have no lasting seizure control on ineffective AED regimens while also showing an enhanced display of neuropsychological comorbidities like anxiety, hyperactivity as well as depression and cognitive problems.

The majority of drug-resistant TLE patients show various grades of sclerosis in the hippocampus and around 25-35 % of patients reveal distinct impairments in their respective brain scans (Magnetic Resonance Imaging or MRI). These MRI-positive patients show the highest grade of drug resistance with the largest debilitating tonic-clonic seizure loads. Patients have often only the last resort of committing themselves to brain resection surgery to enhance the chance of long-lasting seizure freedom. But any brain surgery has its own risks and it is therefore preferential for patients to try one more therapeutic approach (e.g. NRP2945 delivered by chronic subcutaneous injection) before deciding for surgery. This circumstance of diminished quality of life status experienced by these drug-resistant patients qualifies for the selection grouping of these MRI-positive patients as a orphan subgroup in order to be classified under the Orphan Drug Act of both jurisdictions in the US and Europe.

CuroNZ is currently applying for orphan drug status for MRI-positive drTLE patients in Europe and will file for Investigational New Drug Application (IND) for NRP2945 therapy in drTLE patients after the granting of European Orphan drug status in the second half of 2022. CuroNZ believes that the specific mechanism of action that is displayed by NRP2945 will lead to improved synaptogenesis, fast synaptic inhibition and finally to highly improved seizure control ideally resulting in seizure freedom for said patients. A planned clinical phase 2 study at three clinical brain surgery centres in Germany starting at the end of 2022 will provide for clarity whether NRP2945 will become the first-ever therapeutic alternative for brain resection surgery in drTLE patients.