Clinical intelligence
Paradigm Shifts in Clinical Research
Monthly intelligence across all therapeutics for clinical research professionals, sponsors, CROs, and healthcare innovators.
In this issue, we look beyond the headline to what each development means for research teams, sponsors, and the evolving clinical-trial landscape.
From NWCRC, Inc.
AstraZeneca’s anti-IL-33 biologic tozorakimab cuts COPD exacerbations up to 34% in twin phase 3 trials
In the replicate 52-week phase 3 trials OBERON and TITANIA, 2,306 symptomatic COPD patients received 300 mg tozorakimab or placebo every four weeks on top of inhaled maintenance therapy. In former smokers, the annualized rate of moderate-to-severe exacerbations fell 29% in OBERON and 34% in TITANIA versus placebo.
Benefit tracked blood eosinophils: 43% reduction at ≥300 cells/µL, 34% at ≥150, and 23% below 150. Severe exacerbations fell 36% and 33%. Results were presented as a late-breaker at ERS Congress 2026 and published simultaneously in the New England Journal of Medicine.
This would be the first COPD biologic to show efficacy across eosinophil thresholds — including below 150 cells/µL, a group for which no biologic is currently approved. FDA granted priority review; PDUFA decision expected Q1 2027.
FDA clears Motivista, the first authorized treatment for negative schizophrenia symptoms
Motivista (CT-155) is a prescription smartphone app from Click Therapeutics delivering evidence-based psychosocial therapy as an adjunct to antipsychotic therapy in adults. Authorization was supported by the Phase III CONVOKE study: at 16 weeks, Motivista users improved 6.8 points on the CAINS-MAP negative-symptom scale versus 4.2 points for a digital control app — a 62% relative improvement (p=0.0003). No serious treatment-related adverse events were reported.
Negative symptoms are among the most disabling aspects of schizophrenia and until now had no FDA-authorized treatment. This is also a landmark for digital therapeutics: a prescription app authorized through a full Phase III program as a first-in-class therapy.
AbbVie/Genmab combo cuts progression-or-death risk by 51% in first-line DLBCL
Genmab and AbbVie said their epcoritamab plus R-CHOP combination reduced the risk of disease progression or death by 51% versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma. The companies called it the first late-stage study of a bispecific antibody combination to significantly improve progression-free survival in first-line DLBCL; the safety profile was consistent with the known profiles of each agent.
First-line bispecific-antibody combinations are entering the biggest lymphoma population — sponsors running these pivotal trials need experienced clinical-trial consulting support as regimens get more complex.
Roche licenses Alector’s Parkinson’s therapy in deal worth up to $1.27B
Genentech, a Roche unit, will pay Alector $100 million upfront for exclusive worldwide rights to AL050, an enzyme replacement therapy targeting the GCase enzyme deficiency implicated in Parkinson’s disease. Total deal value may reach up to $1.27 billion.
Enzyme-replacement and genetic-target approaches in Parkinson’s are moving from academic programs into large-pharma pipelines — the kind of sponsor shift that shapes outsourcing demand for clinical-trial consulting services.
Experience that strengthens every stage of the clinical trial.
NWCRC, Inc.