Reviva Pharmaceuticals Announces Positive Preliminary Data from RECOVER Trial –

Reviva Pharmaceuticals Holdings, Inc., a Delaware-based company listed on the Nasdaq Capital Market under the symbol RVPH, disclosed key details from its ongoing Phase 3 RECOVER trial in a recent 8-K filing with the Securities and Exchange Commission.

In the filing dated December 16, 2024, Reviva Pharmaceuticals revealed achievements from the open-label extension (OLE) segment of the Phase 3 RECOVER trial, assessing the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. Brilaroxazine, administered once daily, showcased robust broad-spectrum efficacy over a one-year period.

The preliminary topline data announced by Reviva Pharmaceuticals highlighted the positive outcomes from the OLE study. The trial demonstrated brilaroxazine’s efficacy and tolerability across three dosage groups: 15 mg, 30 mg, and 50 mg. Notably, all three doses showed efficacy and were generally well-tolerated by patients.

Key findings from the pooled analysis of brilaroxazine across the dosage groups of 15, 30, and 50 mg included:

– Enrolment of 435 patients in the OLE, with participants from both rollover and de novo categories.
– Demonstrated efficacy in major symptom domains of schizophrenia, including positive and negative symptoms.
– Significant improvements in PANSS total scores, PANSS positive symptoms, and PANSS negative symptoms.
– Strong and sustained efficacy from acute through maintenance treatment over the one-year study period.

Moreover, the safety profile of brilaroxazine over one year reflected encouraging results:

– A low rate of treatment-related adverse events, with most being mild or moderate.
– The most common treatment-related adverse events included weight increase, insomnia, and somnolence.
– No drug-related serious adverse events were observed after the one-year treatment period.

The favourable results reported from the OLE segment of the Phase 3 RECOVER trial further bolster the safety, efficacy, and adherence findings from the double-blind portion of the study.

Reviva Pharmaceuticals highlighted that the RECOVER Study is being conducted globally at multiple centers and includes both rollover participants and de novo participants with stable schizophrenia. Long-term safety data from a minimum of 100 patients who have completed one year of treatment is essential for the New Drug Application (NDA) submission to the FDA.

In conclusion, the disclosed data from the Phase 3 RECOVER trial demonstrates promising efficacy, safety, and patient adherence for brilaroxazine in treating patients with schizophrenia. Reviva Pharmaceuticals remains dedicated to advancing its clinical trials and providing valuable insights into the treatment landscape for schizophrenia.

The company confirmed the information dissemination to the SEC by filing a press release in the Form 8-K, noting that the data should not be regarded as “filed” under the Securities Exchange Act of 1934 or incorporated by reference into any other filings without specific reference.

The report from Reviva Pharmaceuticals sheds light on the progress made in the Phase 3 RECOVER trial, underlining the potential of brilaroxazine as a treatment option for patients with schizophrenia.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Reviva Pharmaceuticals’s 8K filing here.

Reviva Pharmaceuticals Company Profile

Reviva Pharmaceuticals Holdings, Inc, a biopharmaceutical company, discovers, develops, and commercializes next-generation therapeutics for diseases targeting unmet medical needs in the areas of central nervous system, respiratory, inflammatory, and cardiometabolic diseases. The company's lead product candidate comprises brilaroxazine (RP5063) for the treatment of various neuropsychiatric indications, including schizophrenia, bipolar disorder, major depressive disorder, attentiondeficit/hyperactivity disorder, behavioral and psychotic symptoms of dementia and Alzheimer's disease, and Parkinson's disease psychosis; in clinical development respiratory indications, such as pulmonary arterial hypertension and idiopathic pulmonary fibrosis; and in preclinical development for the treatment of psoriasis.