Our Pipeline

A Singular Focus on CNS Orphan Conditions

Noema Pharma is committed to developing treatments for orphan diseases of the central nervous system (CNS), conditions that are characterized by imbalanced neuronal networks that lead to unresolved severe symptoms and significant impact on patients’ lives. This dedication has led to 4 clinical stage assets—including NOE-101 and NOE-105—to be developed in 5 independent indications.

NOE-101 and NOE-105 are poised to produce symptom control aimed at functional restoration. With a clear and fast development path, Noema Pharma sees the potential of 2 additional therapies to effectively treat orphan CNS conditions and provide relief to those in need.

Our Pipeline

Click an asset below to learn more.

Preclinical Phase 1 Phase 2 Phase 3 NOE-101mGluR5 NAM Seizures in TSC NOE-101mGluR5 NAM Pain in TN NOE-105PDE10Ai Tourette syndrome NOE-109mGluR2/3 NAM Undisclosed* Undisclosed* NOE-115TRI

mGluR2/3 NAM, negative allosteric modulator of mGlu2/3 receptors; mGluR5 NAM, negative allosteric modulator of mGlu5 receptor; PDE10Ai, phosphodiesterase 10A inhibitor; TN, trigeminal neuralgia; TRI, triple reuptake inhibitor; TSC, tuberous sclerosis complex.

*Under phase 2 indication validation.

NOE-101

NOE-101 mGluR5 NAM (basimglurant)

For the management of seizures associated with tuberous sclerosis complex (TSC)

Clinical stage: Phase 2b

Galene

A highly selective, potent, and cell-penetrant negative allosteric modulator of mGlu5 receptors for the treatment of seizures associated with TSC.

mGluR5 blockade has been shown to be effective in controlling seizures in a transgenic animal model of TSC.

This effect is explained through a dual mechanism of action:

  • Reducing overactive glutamatergic signaling, an underlying pathology of
    seizures in TSC
  • Normalizing protein synthesis in the brain, a key feature of TSC

Previous studies found NOE-101 to be safe and well tolerated in children and adolescents. Noema’s Galene trial is a phase 2B study to evaluate the efficacy and safety of basimglurant in children and adolescents with seizures associated with Tuberous Sclerosis Complex.

NOE-101

NOE-101 mGluR5 NAM (basimglurant)

For the management of pain associated with trigeminal neuralgia (TN)

Clinical stage: Phase 2b

Libra

A highly selective, potent, and cell-penetrant negative allosteric modulator of mGlu5 receptors for the management of pain associated with TN.

NOE-101 was effective in controlling pain in animal models of neuropathic pain. 

The antinociceptive effect (lowering the perception of pain threshold) of NOE-101 is explained through:

  • Unique chemical and physical properties
  • The ability to block nuclear membrane glutamate mGlu5 receptors, the receptors that are overexpressed in chronic pain

NOE-101 was previously found to be safe and well tolerated in adult subjects. Noema’s LibraTN trial is a global Phase 2b (UC “P”, LC “b”) study in adult patients with TN.

NOE-105

NOE-105 PDE10A inhibitor

For the management of Tourette syndrome (TS) tics

Clinical stage: Phase 2a

Allevia

A potent, selective PDE10A inhibitor that safely modulates dopamine D2 receptor signaling in people with TS.

Increased D2 receptor signaling is suggested to contribute to both the learning and expression of tics, and D2 receptor antagonists (antipsychotics) are the only currently approved treatments for TS. NOE-105 modulates the signaling instead of blocking it.

The ability of NOE-105 to inhibit overactive D2 receptor-mediated motor behaviors has been confirmed in a number of experiments, indicating a potentially well-tolerated and novel treatment for TS.

NOE-105 was previously found to be safe and well tolerated in adult subjects. Noema’s AlleviaTS trial is a dose-ranging study in adult patients with TS.