FDA ‘Study May Proceed’ Letter Received
Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) announced on January 10, 2022 the receipt of a May Proceed letter from the FDA regarding pivotal Phase III clinical trials for brilaroxazine in schizophrenia, including one long-term safety trial. Through the letter, the FDA allowed Reviva to proceed with brilaroxazine’s clinical investigation. Reviva plans two Phase III trials, a four-week efficacy study and a one-year safety study in schizophrenia. Based on the construction of the study, which could be impacted by exogenous events, we see the trial lasting 16 – 18 months with results available in 2H:23. The long-term safety trial is expected to supplement efficacy and safety data from the pivotal trial; Reviva expects both to initiate simultaneously by end of January 2022.
Phase III Trial Details
With the close of the financing in June 2021, Reviva was waiting for its Phase III protocol to be affirmed by the FDA prior to launching the trial. The protocol was cleared in a Study May Proceed letter received on January 10, 2022. Reviva is now ready to begin its pivotal and long-term safety trials and expects it will take two weeks to enroll the first patients. There are now 15 sites selected and two more may be added in the near future. Sufficient amounts of Brilaroxazine are available to start and complete the trial and are now being shipped to the sites.
As we elaborated in our initiation, two Phase III trials will be launched including a four week efficacy study and a one year safety study in schizophrenia. Based on the construction of the study, which could be impacted by exogenous events, we see the trial lasting 16 – 18 months with results available in 2023.
Full Details of Phase II Trial in Acute Schizophrenia
Last April, Reviva provided details regarding its Phase II trial of Brilaroxazine in acute schizophrenia. Among highlights from the study results, the trial met safety and efficacy endpoints, met primary endpoint of reduction in PANSS1, achieved well-rounded effects by reducing both positive and negative symptoms and improving social functioning and cognition, and, perhaps most importantly, presented no metabolic and endocrine side effects2 and no increase in suicidal ideation compared to placebo.
The trial was a randomized, double-blind, placebo-controlled, multicenter Phase II effort to assess safety and efficacy of Brilaroxazine in acute exacerbation of schizophrenia or schizoaffective disorder. It enrolled 234 subjects. Total PANSS was reduced by 20 points from baseline, statistically significant when compared to placebo.
Reviva has a number of upcoming milestones that relate to the launch of its Phase III trial in schizophrenia. Preparation for Phase II trials for Brilaroxazine in additional indications is underway with regulatory work expected in the next quarters followed by launch. We provide additional detail on recent and anticipated achievements below:
➢ Phase III trial design finalization with FDA – January 2022
➢ Launch of Phase III RP5063 trial in acute and maintenance schizophrenia – 1Q:22
➢ Regulatory submissions for PAH & IPF – 1Q:22
➢ KOL event – March 2022
➢ Launch of PAH and IPF Phase II trials – mid-2022
➢ Launch two smaller dose finding studies for ADHD / MDD – mid-2022
➢ ADHD / MDD dose finding study readouts – before year end 2022
➢ Phase III schizophrenia topline data – 1Q:23
Reviva announced FDA clearance for its Phase III protocol and is now planning to start its two anticipated trials for schizophrenia in the next couple weeks. Upcoming milestones for 2022 also include regulatory submissions to the FDA for Phase II studies in pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). We also expect to see some smaller dose finding studies in attention deficit hyperactivity disorder (ADHD) and major depressive disorder (MDD) that should begin in the next few months and read out before year end. A key opinion leader (KOL) event is also in the works and is expected to occur in March.
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1. Positive and Negative Syndrome Scale (PANSS)
2. Metabolic and endocrine side effects include weight gain, elevated blood sugar, increase in lipids, hypothyroidism, and hyperprolactinemia
3. Source: Reviva Pharmaceuticals January 2022 Corporate Presentation.
4. Source: Reviva Pharmaceuticals January 2022 Corporate Presentation.