Noema Pharma announces FDA Investigational New Drug Authorization for Phase 2b study of trigeminal neuralgia therapy

February 14, 2022 08:00 ET

BASEL, Switzerland, Feb. 14, 2022 (GLOBE NEWSWIRE) — Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) had authorized an Investigational New Drug (IND) application to initiate a Phase 2b clinical trial of the mGluR5 inhibitor NOE-101 to treat pain from trigeminal neuralgia (TN).

The trial, named 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. The LibraTN trial is expected to report in H1 2024.

Noema Pharma was seeded by Sofinnova Partners in 2019 and raised 54 million Swiss francs in Series A financing in December 2020.

TN, also known as “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. 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 animal models of neuropathic pain.

"The antinociceptive effect of NOE-101 is explained by its unique chemical and physical properties and its ability to block nuclear membrane mGlu5 receptors, the receptors overexpressed in chronic pain," said George Garibaldi, chief medical officer of Noema Pharma. "Its efficacy is similar to the gold standard achieved by morphine and the non-opiate duloxetine, but with significant potential advantages in terms of side-effects and tolerance. The LibraTN study will help us gain further understanding of the efficacy of NOE-101 in patients with TN-associated pain."

Read the full press release on GlobeNewswire.

Visit the Noema Pharma website for more information.