Challenging the Silence: Schizophrenia’s Economic Impact and the Latest in Clinical Trial Developments
Schizophrenia affects 1% of the US population but imposes a hefty economic burden of $176.3 billion each year made up of healthcare costs, lost tax revenue and costs relating to criminal justice and homelessness. A heavy emotional burden also falls on patients and their families as they navigate life with a serious mental illness that will require lifelong treatment.
Treatment adherence is a significant challenge, often due to the lack of efficacy and prevalence of distressing side effects of approved medications which can include confusion, agitation, weight gain, tremors, and tics. In addition to negative side effects, these drugs are effective against positive symptoms, which include hallucinations and delusions, in just ~70% of patients. The remaining 30% derive no therapeutic benefit from first-line antipsychotics.
There is a clear, unmet need for new, effective schizophrenia treatments. There are 181 clinical trials currently recruiting patients in the US, and their areas of focus include investigating the impact of auditory stimulation on memory and sleep, examining the relationship between inflammation and reward-related brain regions, and minimizing positive and negative symptoms through therapeutics.
As researchers’ understanding of schizophrenia has advanced, the development of effective therapeutics has failed to keep up. However, the number of therapeutics in clinical development is an encouraging sign that researchers are continuing to tackle this complex indication, and that new, safe, effective solutions will soon be available to all patients.
PRISM Headlines in Schizophrenia
Positive Results for Alto Neuroscience in Phase 1 Schizophrenia Study
Alto Neuroscience, Inc. (NYSE: ANRO) has announced positive results from its Phase 1 study of ALTO-101 for cognitive impairment associated with schizophrenia (CIAS). The study demonstrated favorable tolerability and improved pharmacokinetics of ALTO-101 when administered via a transdermal delivery system (TDS) compared to oral administration. Alto ended the day up 1.76% and rose a further 0.29% after market on Tuesday.
FDA Places Hold on Neumora Schizophrenia Study
The FDA has placed a clinical hold on Neumora Therapeutics’ (Nasdaq: NMRA) Phase 1 trial of NMRA-266 after the compound resulted in convulsions in rabbits in the company’s preclinical studies. The company’s stock tumbled 17.5% to close at $11.19 after the announcement last week. The stock closed down an additional 3.51% on Friday and has continued its decline, dropping a further 1.87% in morning trading on Monday. Neumora has a market cap of $1.61 billion.
Reviva Pharmaceuticals’ Phase 3 Schizophrenia Program Receives FDA Acceptance
Reviva Pharmaceuticals (Nasdaq: RVPH) has received acceptance from the FDA for its 4-week registrational Phase 3 program for brilaroxazine in schizophrenia. Reviva’s RECOVER-2 study is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter, 4-week trial designed to assess the safety and efficacy of brilaroxazine in approximately 450 patients with acute schizophrenia compared to placebo.
Nxera Pharma (OTC: SOLTF) and Neurocrine Biosciences (Nasdaq: NBIX) have successfully completed a long-term preclinical toxicity program for NBI-1117568, which is in Phase 2 clinical trials for the treatment of schizophrenia and other neuropsychiatric disorders. The studies have shown that NBI-1117568 meets FDA requirements to allow for safe, long term dosing in future clinical trials. The successful completion of this milestone triggers a $15 million payment to Nxera from Neurocrine.
