Basimglurant

Noema Pharma Receives FDA Fast Track Designation for basimglurant (NOE-101) in Trigeminal Neuralgia

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Tuesday, October 18, 2022
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BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation to its mGluR5 inhibitor basimglurant (NOE-101) for the treatment of trigeminal neuralgia (TN).

Key Points: 
  • BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation to its mGluR5 inhibitor basimglurant (NOE-101) for the treatment of trigeminal neuralgia (TN).
  • "We are very pleased to receive Fast Track designation from the FDA, which is intended to bring promising medicines to patients sooner, and very much underlines the potential of basimglurant in pain management associated with TN," said George Garibaldi MD, President, Head of R&D of Noema Pharma.
  • The FDA authorized Noema Pharma's Investigational New Drug (IND) application to initiate a Phase 2/3 clinical trial of basimglurant in TN in February 2022.
  • Basimglurant, an mGluR5 inhibitor, is Phase 2b-ready for two indications: persistent seizures in Tuberous Sclerosis Complex and severe pain in Trigeminal Neuralgia.

Noema Pharma Announces Completion of Enrollment in the Trigeminal Neuralgia Electronic Diary (TNED) Validation Study

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Tuesday, September 6, 2022
Trigeminal nerve, UCL, University College Hospital, Pain, Trigeminal neuralgia, Noema, Sofinnova, Glutamate (neurotransmitter), Seizure, Brain, LIBRA, Sensation, Diagnosis, Self-assessment, Pain scale, Neuropathic pain, GLOBE, Â, Nerve injury, Company, Diary, Tourette syndrome, Data collection, Face, PDE10A, Polaris Partners, CNS, UCLH, Tuberous sclerosis complex tumor suppressors, Patient, Basimglurant, Medical device, Pharmaceutical industry, Research, Biotechnology

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).

Key Points: 
  • 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).
  • Thirty participants with a confirmed diagnosis of trigeminal neuralgia (TN) volunteered to complete the electronic diary.
  • 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).
  • In addition to being patient friendly and easy to use, TNED is the first electronic diary designed specifically for people who suffer from TN.

Noema Pharma Announces Recruitment of First Patient in Orpheus Phase 2b Study of PDE10A Inhibitor gemlapodect in Adults with Childhood Onset Fluency Disorder

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Thursday, August 4, 2022
People, Orpheus, Disorder, Tuberous sclerosis complex tumor suppressors, Disability, Glutamate (neurotransmitter), Patient, Stuttering, Company, Neurodevelopmental disorder, CNS, Pain, Safety, FDA, Seizure, Adolescence, Solution, Work, Insulin resistance, GLOBE, PDE10A, Person, Sofinnova, Central nervous system, Â, Neuron, Trigeminal neuralgia, Tourette syndrome, Employment, Ageing, Polaris Partners, Basimglurant, COFD, Population, Pharmaceutical industry, Biotechnology, MD

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.

Key Points: 
  • 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.
  • "Recruiting the first participant is an important step in the clinical investigation of gemlapodect in this indication.
  • "Our main goal is to evaluate the safety and efficacy of gemlapodect as a monotherapy for COFD in adults.
  • Gemlapodect, a PDE10A inhibitor, is currently enrolling a Phase 2a clinical trial in patients with Tourette Syndrome.

Noema Pharma Announces FDA Investigational New Drug (IND) Authorization for Orpheus Phase 2b Study of PDE10A Inhibitor Gemlapodect (NOE-105) in Childhood Onset Fluency Disorder

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Monday, June 27, 2022
People, Efficiency, FDA, Patient, Sofinnova, Glutamate (neurotransmitter), Basimglurant, Neurodevelopmental disorder, Polaris Partners, TSC, Biology, Investigational New Drug, GLOBE, CNS, Company, Orpheus, PDE10A, Trigeminal neuralgia, Ageing, Disorder, IND, Disability, Neuron, Seizure, COFD, Tuberous sclerosis complex tumor suppressors, US Foods, Tourette syndrome, Safety, Insulin resistance, Work, Pharmaceutical industry, Noema, Biotechnology, Stuttering, Research, MD

The Orpheus Phase 2b study 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.

Key Points: 
  • The Orpheus Phase 2b study 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.
  • "We have great confidence that gemlapodect will help people who stutter maximize their ability to live life to the fullest."
  • Noema Pharma ( www.noemapharma.com ) is a clinical-stage Biotech company targeting debilitating central nervous system (CNS) indications characterized by imbalanced neuronal networks.
  • Gemlapodect, a PDE10A inhibitor, is currently enrolling a Phase 2a clinical trial in patients with Tourette Syndrome.