Neuroplasticity by Prescription: How Motivista Unlocks Negative Symptoms in Schizophrenia
Dr. Dereck Mush, MD, MBA
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DIGITAL THERAPEUTICS & NEUROPSYCHIATRY
1. FDA Clears Click Therapeutics’ Motivista for Negative Symptoms of Schizophrenia
A screen from Motivista, Click Therapeutics’ prescription digital therapeutic for negative symptoms of schizophrenia. Image: Click Therapeutics.
The FDA has granted 510(k) clearance to Motivista (CT-155), a prescription digital therapeutic for adults with schizophrenia whose positive symptoms are clinically stable. Its indicated use is as an adjunct to clinician-managed outpatient care, including antipsychotic treatment. Negative symptoms can include reduced motivation, diminished pleasure and social withdrawal.
The details:
In the 457-person CONVOKE trial, the average improvement on the CAINS-MAP negative-symptom measure was 6.8 points with Motivista versus 4.2 points with a digital control at 16 weeks. The between-group difference was 2.6 points; the reported effect size was small to moderate.
Click describes the difference between the groups’ improvements as a 62% relative improvement. That does not mean patients’ symptoms fell by 62%.
About 70% of Motivista users maintained the trial’s adherence threshold through week 15. The company reported no serious treatment-related adverse events, while its safety information also records possibly related events in one participant. Longer-term benefit and use outside the trial remain under study.
The Signal: Motivista gives clinicians an authorized option directed at symptoms that can persist despite treatment of hallucinations or delusions. Clearance establishes an additional treatment route; it does not yet settle how widely the app will be prescribed, reimbursed or used over time.
TARGETED ONCOLOGY & IMMUNOTHERAPY
2. Epcoritamab Plus R-CHOP Improves Progression-Free Survival in Frontline Lymphoma Trial
EPKINLY (epcoritamab) product packaging. AbbVie and Genmab have reported Phase 3 results for its use with R-CHOP in newly diagnosed DLBCL. Image: AbbVie Canada.
Genmab and AbbVie reported positive topline results from Phase 3 EPCORE DLBCL-2. The study compared fixed-duration, subcutaneous epcoritamab plus R-CHOP with R-CHOP alone in newly diagnosed large B-cell lymphoma patients with International Prognostic Index scores of 2-5. The combination remains investigational for this frontline use.
The details:
In the overall studied population, the companies reported a 51% relative reduction in the risk of progression or death: hazard ratio 0.49, 95% confidence interval 0.36-0.67, p<0.0001.
The trial also met its primary progression-free survival endpoint in the higher-risk IPI 3-5 population. These are topline results; fuller efficacy, safety and follow-up data are still needed to assess the regimen.
The companies plan to engage regulators. The result does not amount to a frontline approval or establish an overall-survival benefit.
The Signal: This is a meaningful test of whether T-cell redirection can improve initial treatment while retaining R-CHOP as the chemotherapy backbone. Its eventual place in care will depend on the complete data, regulatory decisions and comparisons with other frontline options, including pola-R-CHP.
CARDIOVASCULAR DIAGNOSTICS
3. HeartBeam Gains Breakthrough Designation for Proposed At-Home Heart-Attack Assessment
A patient demonstrates HeartBeam’s portable ECG device. Its proposed heart attack assessment use has FDA Breakthrough Device Designation; it has not received clearance for that use. Image: HeartBeam.
The FDA has granted Breakthrough Device Designation to HeartBeam’s program for helping physicians assess a possible myocardial infarction outside the hospital. The designation gives the company more structured interaction with the FDA as it develops evidence and a pivotal study. It is not authorization to market the system for heart-attack detection.
The details:
HeartBeam’s portable system records cardiac electrical signals in three dimensions and uses software to produce a synthesized 12-lead ECG representation.
The designation was supported by proof-of-concept work and findings from the 134-patient ALIGN-ACS pilot study. HeartBeam says it will seek FDA agreement on a multicenter pivotal study.
The system and synthesis software have existing FDA clearance for specified non-life-threatening arrhythmia assessment. Their cleared labeling explicitly excludes myocardial infarction and ischemia assessment.
The Signal: The clinical problem is real: people with possible heart-attack symptoms may delay seeking help. HeartBeam is testing whether its portable ECG approach can give physicians useful information sooner. The pivotal question is diagnostic performance in the intended setting, followed by a separate FDA decision on the proposed use.
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