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NERV (Minerva Biosciences) presents pre-clinical data on the mechanism of action of its lead drug, Roluperidone.


Minerva Neurosciences Presents Pre-Clinical Data Suggesting a Mechanistic Role of Roluperidone in Addressing Negative Symptoms of Schizophrenia
GlobeNewswire•April 11, 2019
Findings show roluperidone increases release and gene expression of BDNF, as well as release of GDNF

Data presented at 2019 Congress of the Schizophrenia International Research Society

WALTHAM, Mass., April 11, 2019 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced the presentation of a poster at the 2019 Congress of the Schizophrenia International Research Society in Orlando, Florida entitled Roluperidone increases in-vitro Brain-Derived Neurotrophic Factor (BDNF) release: a possible mechanistic role in negative symptoms?

Findings to be presented in Poster #T145 during Poster Session 1 on April 11, 2019, 12:00 p.m. – 2:00 p.m., demonstrate that administration of roluperidone significantly increased BDNF release by astrocytes and hippocampal neurons obtained from the cerebral cortex of newborn rats, as well as the release of GDNF (Glial cell derived neurotrophic factor) in cultured astrocytes. Furthermore, data showed that roluperidone enhanced BDNF gene expression at drug concentrations similar to those observed in humans at tested doses.

Based on these results, researchers suggested that the effect of roluperidone on BDNF and GDNF may indicate the potential of this investigational compound for disease modification and improved neuroplasticity, in addition to its observed effects on the sigma2 and serotoninergic 5-HT2A neurotransmitter pathways.

BDNF is a member of a family of proteins called neurotrophins that plays an important role in the formation and function of neural connections. BDNF is the most widely distributed neurotrophin in the brain and has been associated with neurogenesis, neuroplasticity, neuroprotection, synapse regulation, learning, and memory.1 Its involvement in schizophrenia has also been described.2 GDNF is another neurotrophin that is known to promote the survival of different types of brain cells and has been shown to be essential for the maintenance and survival of dopamine neurons.3

About Roluperidone

Roluperidone is a drug candidate with equipotent affinities for 5-hydroxytryptamine-2A (5-HT2A) and sigma2 and at lower affinity levels, a1-adrenergic receptors. Roluperidone exhibits no affinity for dopaminergic, muscarinic, cholinergic and histaminergic receptors. Roluperidone has no direct dopaminergic post-synaptic blocking effects, known to be involved in some side effects like extrapyramidal symptoms, sedation, prolactin increases and weight gain.

A pivotal Phase 3 clinical trial is ongoing with roluperidone as monotherapy for negative symptoms in patients diagnosed with schizophrenia. Approximately 500 patients are expected to be enrolled at approximately 60 clinical sites in the U.S. and Europe. Top-line results from the 12-week double blind phase of this trial are expected in mid-2019.

About Minerva Neurosciences:

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone (MIN-101), in clinical development for schizophrenia; MIN-117, in clinical development for major depressive disorder (MDD); seltorexant (MIN-202 or JNJ-42847922), in clinical development for insomnia and MDD; and MIN-301, in pre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visit www.minervaneurosciences.com.

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