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

• Efficacy and safety study evaluating 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, June 27, 2022 (GLOBE NEWSWIRE) — Noema Pharma, a clinical-stage biotech company targeting debilitating central nervous system (CNS) indications, today announces the US Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to initiate the Orpheus Phase 2b study of Noema’s PDE10A inhibitor gemlapodect (NOE-105) in Childhood Onset Fluency Disorder (COFD, also known as stuttering).

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. The study is expected to read-out at the end of 2023.

“We are very pleased to announce an additional IND authorization, which reflects the dedication and efficiency of our clinical development team,” Luigi Costa, Chief Executive Officer of Noema. “We have great confidence that gemlapodect will help people who stutter maximize their ability to live life to the fullest.”

“Stuttering is a condition that is often associated with children but is also common among adults, with devastating consequences for patients and negatively impacts their ability to function and live normal lives,” George Garibaldi, MD, President, Head of Research and Development at Noema Pharma. “People who stutter more frequently live in isolation, have significant deficits in yearly earnings, and are more likely to be unemployed compared to people with regular speech fluency. To this date, effective and safe treatments are still missing. The latest research of the biology of stuttering through advanced neuroimaging techniques converges on the significant role of dopaminergic hyperactivity in speech dysfluency, which provides a solid mechanistic rationale for studying gemlapodect in this indication.”

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 the age of 16, 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 drug has been specifically approved for this disorder, patients 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 D2 receptor signaling and is not associated with the metabolic abnormalities that are typically observed with most second-generation antipsychotics.

About Noema Pharma
Noema 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 (TSC) and severe pain in Trigeminal Neuralgia (TN). 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.

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