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Reviva Pharmaceuticals Holdings Inc (NASDAQ: RVPH) has announced the full details of its Phase 2 trial evaluating its lead drug candidate, RP5063 (brilaroxazine), for Acute Schizophrenia.
Brilaroxazine demonstrated high affinity and selectivity for key serotonin receptors (5-HT1A/2A/2B/7) through its combination of potent affinity and selectivity for target receptors implicated for schizophrenia and its comorbid symptoms.
In the 234-subject Phase 2 trial, brilaroxazine met its primary endpoint, reducing the total Positive and Negative Syndrome Scale (PANSS used for measuring symptom severity of patients with schizophrenia) at the end of the treatment from baseline versus placebo.
The PANSS total score was down by 20 points, a statistically significant treatment difference from the placebo.
Brilaroxazine also mitigated positive symptoms and negative symptoms and improved social functioning and cognition.
The drug candidate also met all safety endpoints with no metabolic (weight gain, elevated blood sugar, increased lipids), no endocrine (hypothyroidism, hyperprolactinemia) side effects, and no increase in suicidal ideation compared to placebo.
Also, the FDA has agreed to consider a potential ‘Superior Safety’ label claim if there is a positive outcome on a relevant endpoint in the Phase 3 study in schizophrenia.
Price Action: RVPH shares are trading 12% higher at $4.84 in the premarket trading session on the last check Monday.
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