PharmaNeuroBoost’s lead product in major depression receives IND approval from FDA
PharmaNeuroBoost NV (PNB) reported that the U.S. food and Drug Administration (FDA) approved the Investigational New Drug (IND) application for PNB01. PNB01 is a proprietary owned, fixed dose combination of citalopram and low dose pipamperone, and is under development for the treatment of major depressive disorder. The IND approval permits PharmaNeuroBoost to initiate a Phase I clinical trial in healthy volunteers in the US.
Previously, promising results with PNB01 over standard of care citalopram have been obtained in a UK Phase II Proof of Concept trial in patients with moderate to severe Major Depressive Disorder. PNB is currently analyzing the data of its successful European Phase II study in MDD and planning late stage development of PNB01. PharmaNeuroBoost NV, founded in 2006, is a biopharmaceutical company located in Belgium, dedicated to developing best in class CNS therapeutics, based on solid intellectual property. The company’s primary goal is to significantly improve current therapy targeted against mood, anxiety, and psychotic disorders. The two front-running clinical stage proprietary projects (PNB01 and PNB02) are targeted against major depression and schizophrenia, respectively.
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