Schizophrenia – Unmet Need – Detailed, Expanded Analysis (Cognitive Impairment)

According to Clarivate epidemiology, cognitive dysfunction (e.g., impaired attention / vigilance, memory, executive function) occurs in the vast majority of diagnosed schizophrenia patients and has a detrimental impact on their daily activities, occupational and social functioning, and adherence to antipsychotic treatment. Although the schizophrenia drug market is crowded, no drugs are approved specifically to treat cognitive impairment associated with schizophrenia (CIAS). Psychiatrists may prescribe off-label treatments and/or a nonpharmacological approach such as cognitive remediation, which is recommended by some recent treatment guidelines for schizophrenia; however, no therapy has demonstrated consistent efficacy in improving cognition. Although the late-phase pipeline for CIAS is sparse, Boehringer Ingelheim’s BI 425809, a glycine transporter-1 inhibitor, has had promising Phase II results and received FDA breakthrough therapy designation for CIAS. In addition, some agents with novel mechanisms of action are in early-phase development for CIAS. Overall, given the lucrative commercial potential for a drug demonstrating efficacy and safety in this underserved schizophrenia segment, it is essential for drug developers to understand the physician-perceived level of unmet need in terms of drug attributes and areas of opportunity in CIAS.

QUESTIONS ANSWERED

• What is the relative importance of a therapy’s various attributes in psychiatrists’ prescribing decisions for CIAS (e.g., improvement in overall cognition, improvement in patient functioning, improvement in individual cognitive domains, long-term tolerability)?
• How do U.S. and European psychiatrists rate the performance of various current therapies, including nonpharmacological therapy (e.g., computer-assisted cognitive remediation), on key treatment drivers and goals for CIAS?
• What are the prevailing areas of unmet need and opportunity in the treatment of CIAS? What is the comparative level of need for improved treatment options in CIAS and other schizophrenia patient segments (e.g., negative symptoms)?
• Based on conjoint analysis and TPP simulation, what trade-offs among efficacy, safety, delivery profile, and price are acceptable to psychiatrists for a hypothetical new drug for CIAS?

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. One market scenario is profiled in detail by Clarivate experts and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Geography: United States, United Kingdom, France, Germany

Primary research: Survey of 60 U.S. and 31 European psychiatrists fielded in April 2022

Key therapies covered: Aripiprazole (oral), risperidone (oral), rivastigmine, memantine, donepezil, modafinil, nonpharmacological therapy (e.g., computer-assisted cognitive remediation)

Content highlights

• Target Product Profile (TPP) simulator based on conjoint analysis methodology
• Stated versus derived importance of product attributes on prescribing behavior
• Assessment of current drug performance against treatment drivers and goals
• Physician perceptions of unmet needs in the indication and related indications
• Analysis of remaining drug development opportunities