8-K: Reviva Pharmaceuticals Announces Positive Long-Term Data for Brilaroxazine in Schizophrenia Treatment

Reviva Pharmaceuticals reports positive preliminary topline data from the open-label extension of its Phase 3 RECOVER trial, showing sustained efficacy and tolerability of brilaroxazine in schizophrenia patients over one year.

Summary

• Reviva Pharmaceuticals announced positive preliminary results from the open-label extension (OLE) of their Phase 3 RECOVER trial for brilaroxazine, a potential treatment for schizophrenia.
• The study evaluated the long-term safety and tolerability of brilaroxazine over one year.
• A total of 435 patients were enrolled in the OLE, with 156 rolling over from the double-blind phase and 279 new participants.
• Preliminary efficacy data is based on 113 patients who completed 52 weeks of treatment, while safety data includes all 435 participants.
• Brilaroxazine demonstrated dose-dependent efficacy, with PANSS total score decreases of -15.2, -18.6, and -20.8 points for the 15mg, 30mg, and 50mg doses, respectively.
• Pooled data showed a significant decrease in PANSS total scores by 18.6 points, positive symptoms by 5.2 points, and negative symptoms by 4.5 points.
• In rollover patients, brilaroxazine led to a 30-point decrease in PANSS total scores in 86.76% of patients, a 40-point decrease in 64.70% of patients, and a 50-point decrease in 33.82% of patients.
• The treatment was generally well-tolerated, with 15.2% of participants reporting treatment-related adverse events, mostly mild or moderate.
• The most common adverse events were weight increase (3.2%), insomnia (1.8%), and somnolence (1.6%).
• The treatment discontinuation rate was 35%, primarily due to withdrawal of consent (22%).
• No drug-related serious adverse events were observed.

Sentiment

Score: 8

Explanation: The document presents positive preliminary results for a drug in development, with strong efficacy and a good safety profile. The sentiment is optimistic, but the preliminary nature of the data and the discontinuation rate temper the enthusiasm slightly.

Positives

• Brilaroxazine showed sustained efficacy in reducing schizophrenia symptoms over a one-year period.
• The drug was generally well-tolerated, with most adverse events being mild or moderate.
• There were no drug-related serious adverse events reported.
• The study demonstrated dose-dependent efficacy, suggesting flexibility in treatment options.
• The results support the potential of brilaroxazine to address long-term treatment needs in schizophrenia.

Negatives

• The treatment discontinuation rate was 35%, which is relatively high, although primarily due to withdrawal of consent.
• Some patients experienced treatment-related adverse events, such as weight increase, insomnia, and somnolence.

Risks

• The 35% discontinuation rate, although largely due to withdrawal of consent, could indicate challenges in long-term adherence.
• The full data set, expected in Q1 2025, will be crucial to confirm these preliminary findings.
• The company needs to successfully navigate the regulatory process for NDA submission to the FDA.

Future Outlook

The company anticipates reporting the full data set from the OLE portion of the RECOVER study in Q1 2025, which will include long-term safety, tolerability, and efficacy data, as well as vocal and blood biomarker data. Reviva intends to develop brilaroxazine for other neuropsychiatric indications and has also shown promising nonclinical activity for inflammatory diseases.

Management Comments

• Laxminarayan Bhat, Ph.D., stated that the topline data builds on strong clinical evidence demonstrating that brilaroxazine can improve all major symptom domains of schizophrenia and shows sustained efficacy over time.
• Dr. Scott Bartley, MD, noted that the broad-spectrum improvements in all major symptom domains, along with low treatment discontinuation rates, are encouraging and support the potential of brilaroxazine to reduce the burden of schizophrenia.

Industry Context

This announcement is significant in the context of the schizophrenia treatment landscape, where there is a need for therapies that address all major symptom domains, including negative symptoms, and have good long-term tolerability and adherence. The positive results for brilaroxazine could position it as a competitive option in the market.

Comparison to Industry Standards

• The reported 18.6-point decrease in PANSS total scores is clinically meaningful and compares favorably to other antipsychotics in the market.
• The low rate of serious adverse events is a positive sign, as many existing antipsychotics are associated with significant side effects.
• The 35% discontinuation rate, while higher than some studies, is primarily due to withdrawal of consent, which is not uncommon in long-term trials.
• Compared to companies like Alkermes (ALKS) with their long-acting injectable antipsychotics, Reviva's oral brilaroxazine offers a different administration route, which may appeal to some patients.
• The focus on broad-spectrum efficacy, including negative symptoms, is a key differentiator, as many current treatments primarily target positive symptoms.

Stakeholder Impact

• Shareholders may view the positive results as a positive development for the company's stock.
• Patients with schizophrenia may benefit from a new treatment option with a favorable safety profile.
• Healthcare providers may have a new tool for managing schizophrenia.
• The company's employees may be motivated by the progress of the clinical trial.

Next Steps

• The company will report the full data set from the OLE portion of the RECOVER study in Q1 2025.
• Reviva plans to submit an NDA to the FDA for brilaroxazine.
• The company intends to develop brilaroxazine for other neuropsychiatric indications.

Key Dates

Keywords

brilaroxazine, schizophrenia, clinical trial, Phase 3, RECOVER, long-term safety, efficacy, PANSS, adverse events, CNS