Boehringer Ingelheim and Click Therapeutics’ digital therapeutic has met its primary endpoint in a Phase III schizophrenia study.
While not providing detailed data, Boehringer said the prescription digital therapeutic (PDT), CT-155, offered clinically meaningful reductions in experiential negative symptoms associated with the neuropsychiatric disorder when used as an adjunct therapy to standard of care (SoC) antipsychotics.
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During the 16-week CONVOKE study (NCT05838625), the efficacy and safety of CT-155 were compared with a digital control app, with attained clinical assessment interview for negative symptoms, motivation and pleasure scale (CAINS-MAP) values revealing that the treatment could significantly minimise symptoms compared with baseline measures.
Detailed results will be presented at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress being held in Amsterdam, the Netherlands, on 13 October.
Following this positive outcome, Boehringer and Click will likely file for regulatory approval for CT-155, which will likely be expedited due to the US Food and Drug Administration’s (FDA’s) decision to award the therapy with breakthrough device designation in 2024.
If approved, CT-155 would be the first digital therapy to be given the FDA go-ahead for the treatment of schizophrenia-associated negative symptoms – addressing a significant unmet need for patients with this indication.
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By GlobalDataThe PDT could also enhance current treatment options for patients in terms of overall well-being, which primarily centre around the management of psychotic symptoms and hallucinations with drugs in combination with cognitive behavioural therapy (CBT).
Click’s chief medical and scientific officer Shaheen Lakhan noted: “The observed clinical benefit on experiential negative symptoms in this study – without additional known safety concerns – marks a notable advancement in understanding how we might address this long unmet need.”
Evolution of the treatment landscape
Though the SoC for schizophrenia has historically revolved around the use of drugs targeting dopamine receptors, these therapies are often associated with significant side effects such as disordered movement and metabolic disturbances.
This has resulted in an industry push to identify and develop drugs around novel or combination targets that offer an improved side effect profile while maintaining efficacy.
According to GlobalData’s Intelligence Center, combination therapies targeting dopamine and serotonin receptors are a particularly popular choice for drug developers, with 94 ongoing clinical trials in Phases I to III involving drugs in this category.
GlobalData is the parent company of Medical Device Network.
Meanwhile, biotech and pharma companies have also been exploring the efficacy of choline receptor agonists in the indication, with 13 trials currently underway for drugs in this class.
Notably, research in this area led to the approval for BMS’s Cobenfy (xanomeline and trospium) in 2024, which GlobalData forecasts will hit a value of $4.3bn in 2031, taking a 25% share of the market predicted to reach $17bn in the same year.
However, analysts at GlobalData noted that Cobenfy will not necessarily replace atypical antipsychotics operating through the dopaminergic system, but will instead be a secondary option for patients unable to tolerate their associated side effects.
Psychedelics have also been grabbing attention in this indication, with a preclinical study from the University of California, Davis suggesting that its lysergic acid diethylamide (LSD) analogue can manage schizophrenia symptoms by promoting neuroplasticity.
Big pharma has also taken an early-stage interest in this drug class, with key player AbbVie currently mulling over an acquisition of next-generation psychedelic biotech, Giglamesh Pharmaceuticals, following its collaboration announcement in May.
However, psychedelics have proven a difficult development area, with Lykos Therapeutics having its MDMA based therapy for post-traumatic stress disorder rejected by the FDA. The drug was set to be the first approved psychedelic in the US. Companies have been redesigning their trials to try and avoid the pitfalls faced by Lykos.
