Noema Pharma announces first patient dosed in phase 2b study of NOE-101 in trigeminal neuralgia - Gilde Healthcare

Noema Pharma announces first patient dosed in phase 2b study of NOE-101 in trigeminal neuralgia

February 22, 2022
Basel, (Switzerland) & Utrecht (the Netherlands)

Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system diseases, today announces the dosing of its first patient in its Phase 2b clinical trial of the mGluR5 inihibitor NOE-101 in trigeminal neuralgia (TN).

LibraTN is a multi-center, 24-week, prospective, double-blind, randomized-withdrawal, placebo-controlled study to evaluate the efficacy and safety of NOE-101 in adults with pain associated with TN. NOE-101 has previously been found to be safe and well tolerated in adult subjects. LibraTN is expected to report in H1 2024.

TN, also called “tic douloureux”, is a chronic 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 nerve lesion. New cases of TN affect 4 to 5 of every 100,000 people in the United States each year.

“LibraTN is an excellent opportunity to evaluate a novel therapeutic option in patients with trigeminal neuralgia who are hoping for effective solutions to manage their excruciating pain,” said Dr. Hossein Ansari, director of Facial Pain Clinic at Kaizen Brain Center, Associate professor of neurology at the University of California, San Diego, and principal investigator for the study. “LibraTN was designed in partnership with patients and, in addition to understanding the safety and efficacy of NOE-101, will address many questions that matter most for people with this painful condition. Trigeminal neuralgia, also known as the “suicide pain”, is a rare condition characterized by pain flares resembling electric shocks that attack one side of the face and is associated with a significant negative impact on patients functioning”.

“It’s very exciting to have dosed our first patient in this Phase 2b trial in trigeminal neuralgia. We see great potential for NOE-101 in pain management due to its ability to block the nuclear membrane mGlu5 receptors which are overexpressed in chronic pain,” said George Garibaldi, Chief Medical Officer of Noema Pharma. “Treatment options are scarce in TN with only one treatment option that was approved over 50 years ago. We believe that patients suffering from TN deserve the benefit of the latest mechanistic discoveries. NOE-101 has great potential to provide these patients with the efficacy they need and a safety profile compatible with long-term use.”

NOE-101 is 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.

About Noema Pharma
Noema Pharma is a Swiss-based company targeting orphan neurological disorders characterized by imbalanced neuronal networks. The company is developing four advanced stage well characterized therapeutics in-licensed from Roche. Lead product NOE-101, an mGluR5 inhibitor, is currently evaluated in pain associated with Trigeminal Neuralgia (TN) and in seizures in Tuberous Sclerosis Complex (TSC). NOE-105, a PDE10A inhibitor, is being developed in Tourette Syndrome and childhood onset fluency disorders. The Company is undertaking pre-clinical studies in undisclosed indications for two additional clinical-stage assets, NOE-109, an mGluR2/3 inhibitor, and NOE-115, a triple re-uptake inhibitor. Noema Pharma is funded by leading venture capital firms Sofinnova Partners and Polaris Partners. Investors include Gilde Healthcare, Invus and Biomed Partners.

About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor with two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in fast growing, innovative companies active in (bio)pharmaceuticals, healthtech and medtech that are based in Europe and North America. For more information, please visit www.gildehealthcare.com.

First Enrolment in the ProVIDE Clinical Study for BPH Treatment

ProVerum Limited, an Irish medical device company developing a minimally invasive solution to treat benign prostatic hyperplasia (BPH) in the doctor’s office, today announced the commencement of the ProVIDE pivotal clinical trial to evaluate the...
June 10, 2022

Gilde Healthcare company Big Health receives NICE digital therapeutics guidance confirming clinical and cost effectiveness

Big Health has become the first digital therapeutics company to receive guidance from the National Institute for Health and Care Excellence (NICE), which has recommended Sleepio as a cost-saving option for treating insomnia in a move that heralds...
May 20, 2022

Gilde Healthcare portfolio company Synexa Life Sciences acquires Finnish CRO Syrinx Bioanalytics to expand bioanalysis capabilities in clinical drug development

Gilde Healthcare portfolio company Synexa Life Sciences BV, a global leader in specialist biomarker and bioanalysis research services, has today announced that it has acquired Syrinx Bioanalytics, a bioanalytical CRO based in Turku, Finland. The move...
May 19, 2022