NEWS DETAIL

  • Source : Globenewswire
  • Date : 2022-02-14
  • Event type : Phase 2
  • Companies : Roche

Noema Pharma Announces FDA Investigational New Drug Authorization for Phase 2b LibraTN Study of mGluR5 Inhibitor NOE-101 in Trigeminal Neuralgia

  • Study to evaluate efficacy of NOE-101 for management of pain associated with trigeminal neuralgia

BASEL, Switzerland, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, today announces the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to initiate a Phase 2b clincial trial of the mGluR5 inihibitor NOE-101 in trigeminal neuralgia (TN).

The LibraTN trial 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.

"Severe neuropathic pain of the face can be excruciating and is often resistant to available treatments," said Allison S. Feldman, Chief Executive Officer of the Facial Pain Association. "Typically anticonvulsants have been used to treat TN, but these drugs are not always well tolerated and need to be carefully titrated. NOE-101's promising safety profile and mechanism of action are encouraging signs that its clinical development could provide alternative treatments for those living with TN who currently have little or no options."

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. 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."

About Noema Pharma
Noema Pharma is a Swiss-based company targeting orphan CNS diseases characterized by an imbalanced neuronal network. The company has an extensive pipeline of products in-licensed from Roche and with strong safety packages, including lead product NOE-101, a mGluR5 inhibitor, which is Phase 2b ready for persistent seizures in Tuberous Sclerosis Complex (TSC) and severe pain in Trigeminal Neuralgia (TN). NOE-105, a PDE10A inhibitor, is in Phase 2 for the treatment of Tourette Syndrome. Noema Pharma was seeded by the leading European venture capital firm Sofinnova Partners.

Contacts


Noema Pharma
Luigi Costa
Chief Executive Officer
[email protected] 
Investors
LifeSci Advisors – Guillaume van Renterghem
[email protected] 
41 (0) 76 735 01 31
Media
LifeSci Advisors – Bernhard Schmid
[email protected] 
41 (0) 44 447 12 21