Minerva Neurosciences Presents Pre-Clinical Data Suggesting a Mechanistic Role of Roluperidone in Addressing Negative Symptoms of Schizophrenia
Findings show roluperidone increases release and gene expression of BDNF, as well as release of GDNF
Data presented at 2019
Findings to be presented in Poster #T145 during Poster Session 1 on
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
Roluperidone is a drug candidate with equipotent affinities for 5‑hydroxytryptamine-2A (5-HT2A) and sigma2 and at lower affinity levels, α1-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.
Forward-Looking Safe Harbor Statement
This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the timing and scope of future clinical trials and results of clinical trials with roluperidone, seltorexant, MIN-117 and MIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, whether roluperidone, seltorexant, MIN-117 and MIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the
|William B. Boni|
|VP, Investor Relations / Corp. Communications|
|Minerva Neurosciences, Inc.|
1 BDNF and schizophrenia: from neurodevelopment to neuronal plasticity, learning and memory, R. Nieto et al, Frontiers in Psychiatry,
2 Childhood trauma interacted with BDNF Val66Met influence schizophrenic symptoms, Xiao-jiao Bi et al, Medicine, http://dx.doi.org/10.1097/MD.0000000000010160
Source: Minerva Neurosciences, Inc