NOE-109

Study to validate the novel Patient-Reported Electronic Diary designed to more efficiently and accurately measure disease burden associated with trigeminal neuralgiaLIBRATN (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 PharmaNoema 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. Contacts Noema PharmaLuigi CostaChief Executive Officerinfo@noemapharma.comInvestorsLifeSci Advisors – Guillaume van Renterghemgvanrenterghem@lifesciadvisors.com+41 (0) 76 735 01 31MediaLifeSci Advisors – Bernhard Schmidbschmid@lifesciadvisors.com+41 (0) 44 447 12 21

Study evaluating the safety and efficacy of gemlapodect (NOE-105) in adults with Childhood Onset Fluency Disorder (also known as stuttering)Top-line data expected in Q4 2023 BASEL, Switzerland and BOSTON, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announced the dosing of the first patient in the Orpheus Phase 2b study of Noema’s PDE10A inhibitor gemlapodect (NOE-105) in Childhood Onset Fluency Disorder (COFD—commonly known as stuttering). Orpheus is a multi-center, 11-week prospective, placebo-controlled study to evaluate the safety and efficacy of gemlapodect as monotherapy in adults suffering from COFD. The study is expected to report at the end of 2023. "Recruiting the first participant is an important step in the clinical investigation of gemlapodect in this indication. I am very pleased with the progress we are making in the Orpheus study with significant interest from people struggling from the condition to participate in the study," said Dr Gerald Maguire, Principal Investigator of the Orpheus Study. "Our main goal is to evaluate the safety and efficacy of gemlapodect as a monotherapy for COFD in adults. People who stutter are looking for solutions that would enable them to achieve their full potential, both personally and professionally. In the absence of any FDA approved therapies for this condition that affects over one percent of our population, persons who stutter are eagerly awaiting an effective, safe, and proven therapy." “The World Stuttering Network is committed to helping people who stutter at different stages of their lives”, said Tom Scharstein, president of the World Stuttering Network. “In their early adulthood, people who stutter face significant challenges in their social and professional functioning, specifically as they are in search of employment and expanding their social network beyond their childhood friends. Providing them with help to overcome these challenges would enable them to reach their optimal potential." "Treatment options for Childhood Onset Fluency Disorder are severely lacking, with currently no FDA-approved therapy," said George Garibaldi, MD, President and Global Head of Research and Development at Noema Pharma. "The Orpheus study presents an exciting opportunity to investigate the potential of a novel therapeutic candidate in this common but often overlooked condition, which can have devastating effects in the personal and professional lives on those who suffer from it. The study also marks the expansion of Noema Pharma's clinical pipeline and complements Noema’s continued commitment to our mission of developing therapies for underserved conditions of the central nervous system." Childhood onset fluency disorder (COFD), also known as stuttering, is a neurodevelopmental disorder most often exhibited in patients at an early age, affecting ~5% of children aged six and older. While most children grow out of their stuttering by their adolescent years, approximately 20% continue to be affected by the condition into adulthood, leading to significant disability at school, work, and in their social life. While no medication has been specifically approved for this disorder, patients often rely heavily on off-label use of antipsychotics, which provide some clinical benefit but are associated with significant long-lasting motor and metabolic side effects, including insulin resistance and type 2 diabetes. Gemlapodect is an inhibitor of PDE10A, an enzyme highly expressed in medium spiny neurons of the mammalian striatum, which modulates dopamine D2 receptor signaling and does not appear to be associated with the metabolic abnormalities that are typically observed with most second-generation antipsychotics. About Noema PharmaNoema 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. Contacts Noema PharmaLuigi CostaChief Executive Officerinfo@noemapharma.comInvestorsLifeSci Advisors – Guillaume van Renterghemgvanrenterghem@lifesciadvisors.com+41 (0) 76 735 01 31MediaLifeSci Advisors – Bernhard Schmidbschmid@lifesciadvisors.com+41 (0) 44 447 12 21