Study to validate the novel Patient-Reported Electronic Diary designed to more efficiently and accurately measure disease burden associated with trigeminal neuralgia
LIBRATN (NOE-101 Phase 2/3 study in Trigeminal Neuralgia) is on track to report top-line data in H1 2024
BASEL, Switzerland and BOSTON, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces it has completed participant enrollment and data collection in the validation study of a novel Trigeminal Neuralgia Electronic Diary (TNED). The results will be presented at a scientific meeting and published in a specialized peer-reviewed journal.
The TNED validation study was conducted in two leading centers in the US and Europe, the result of a collaboration between University College London Hospitals UCLH/UCL in the UK, the Kaizen Brain Center in the US, the Trigeminal Neuralgia Association UK, and Noema Pharma. Thirty participants with a confirmed diagnosis of trigeminal neuralgia (TN) volunteered to complete the electronic diary. The diary, which was completed daily, includes a self-assessment of the different aspects of their condition; frequency and severity of intermittent attacks, also known as “flare-ups”, the duration of associated continuous pain when present, and the impact of these attacks on personal, social, and professional functioning. While the analysis of the validation data is ongoing, the electronic diary was generally found to be easy to use and enabled participants to accurately describe the burden of trigeminal neuralgia (TN).
“The TNED is a better alternative to the conventional paper-and-pencil method that is used to report the different aspects of facial pain,” said Professor Joanna Zakrzewska Principal Investigator of the LIBRA trigeminal neuralgia study at UCLH/UCL. “In addition to being patient friendly and easy to use, TNED is the first electronic diary designed specifically for people who suffer from TN. It measures different aspects of the condition and will allow regular measurement of the different aspects of the condition. In addition to being an excellent research tool for TN clinical studies, TNED can be used by patients with TN in clinical practice as a reliable tool to communicate symptom severity and frequency to their health care provider leading to improved quality of care as it enables assessment of the timing of flare ups and the efficacy of medication.”
"It's very exciting to have completed the recruitment of the TNED validation study. This research tool is very well received by patients with TN, easy to use, and has the potential of becoming a routine activity with minimal burden on patients. We see great potential for the TNED to become a state-of-the-art research tool to be used in all TN clinical trials, including Noema’s LIBRATN," said George Garibaldi, President and Head of Research and Development at Noema Pharma. "Treatment options are scarce in TN with only one treatment that was approved over 50 years ago. We believe that patients suffering from TN deserve the benefit of the latest innovations and discoveries. Through the TNED, Noema is making a significant contribution to research in this field.”
TN, also called “tic douloureux”, is a chronic severe pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. TN is a form of neuropathic pain, associated with nerve injury or a nerve lesion. New cases of TN affect 4 to 5 of every 100,000 people in the United States each year.
Noema is investigating the effect of NOE-101 (basimglurant), a highly selective, potent, and cell-penetrant negative allosteric modulator of mGlu5 receptors for the management of pain associated with TN. It was effective in controlling pain in multiple animal models predictive of a therapeutic effect in neuropathic pain. The currently ongoing placebo-controlled clinical study named LIBRATN (NCT05217628) aims to recruit up to 200 participants in centers across Europe and the U.S. Top-line data from the study is expected in H1 2024.
About Noema Pharma
Noema Pharma (www.noemapharma.com) is a clinical-stage Biotech company targeting debilitating central nervous system (CNS) indications characterized by imbalanced neuronal networks. The company is actively developing three mid-clinical-stage therapeutic product candidates in-licensed from Roche. Basimglurant, an mGluR5 inhibitor, is Phase 2b-ready for two indications: persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia. Gemlapodect, a PDE10A inhibitor, is currently enrolling a Phase 2a clinical trial in patients with Tourette Syndrome. The Company has completed validation studies and is pursuing the development of NOE-115 in Behavioral Metabolic Cluster disorders. It is also planning to develop NOE-109 an mGluR2/3 inhibitor, in undisclosed indications. Noema Pharma was founded in 2020 by the leading venture capital firm Sofinnova Partners. Investors include Polaris Partners, Gilde Healthcare, Invus and Biomed Partners.