Poster
2
(#2) Number Needed to Treat (NNT) and Number Needed to Harm (NNH) Analysis of MM120 in Generalized Anxiety Disorder: A Phase 2b Trial Evaluation
Psych Congress 2025
Abstract: Background:
Generalized anxiety disorder (GAD) is an impairing disorder encompassing several symptoms, including excessive worrying, restlessness, and irritability. This analysis utilized NNT and NNH to assess the clinical benefit-risk profile of MM120 (lysergide d-tartrate), under investigation as a potential therapy in adults with GAD.
Methods:
This analysis evaluated data from a 12-week phase 2b (NCT05407064) multicenter, randomized, double-blind, placebo-controlled trial. NNT and NNH values were computed as the inverse of the absolute risk reduction for achieving a specified outcome with a single administration of 100 µg MM120 versus placebo. Additionally, 95% confidence intervals (CI) were calculated and the likelihood to be helped or harmed (LHH) was derived by the ratio of NNH to NNT.
Results:
At Week 1, NNTs were 3 (95% CI: 2-5) for clinical response and 6 (95% CI: not significant [NS]) for clinical remission. By Week 12, NNTs were 3 for clinical response (95% CI: 2-8) and 4 for clinical remission (95% CI: 3-15). The NNH for treatment-emergent adverse events (TEAEs) leading to study withdrawal was 40 (95% CI: NS). LHH values were 13.7 for clinical response and 10.8 for clinical remission, calculated relative to study discontinuation due to TEAEs.
Conclusion:
A single administration of 100 µg MM120 demonstrated rapid and clinically meaningful efficacy with a favorable tolerability profile in adults with GAD. At Week 12, treating every 3 or 4 patients with MM120 instead of placebo resulted in one additional patient achieving clinical response and remission, respectively. Future trials are needed to expand on these findings.
Short Description: This analysis assessed the potential clinical benefit-risk profile of MM120 (lysergide d-tartrate) in adults with GAD by calculating the number needed to treat (NNT), the number needed to harm (NNH), and likelihood to be helped or harmed (LHH) based on data from a phase 2b trial (NCT05407064).
Name of Sponsoring Organization(s): MindMed
Generalized anxiety disorder (GAD) is an impairing disorder encompassing several symptoms, including excessive worrying, restlessness, and irritability. This analysis utilized NNT and NNH to assess the clinical benefit-risk profile of MM120 (lysergide d-tartrate), under investigation as a potential therapy in adults with GAD.
Methods:
This analysis evaluated data from a 12-week phase 2b (NCT05407064) multicenter, randomized, double-blind, placebo-controlled trial. NNT and NNH values were computed as the inverse of the absolute risk reduction for achieving a specified outcome with a single administration of 100 µg MM120 versus placebo. Additionally, 95% confidence intervals (CI) were calculated and the likelihood to be helped or harmed (LHH) was derived by the ratio of NNH to NNT.
Results:
At Week 1, NNTs were 3 (95% CI: 2-5) for clinical response and 6 (95% CI: not significant [NS]) for clinical remission. By Week 12, NNTs were 3 for clinical response (95% CI: 2-8) and 4 for clinical remission (95% CI: 3-15). The NNH for treatment-emergent adverse events (TEAEs) leading to study withdrawal was 40 (95% CI: NS). LHH values were 13.7 for clinical response and 10.8 for clinical remission, calculated relative to study discontinuation due to TEAEs.
Conclusion:
A single administration of 100 µg MM120 demonstrated rapid and clinically meaningful efficacy with a favorable tolerability profile in adults with GAD. At Week 12, treating every 3 or 4 patients with MM120 instead of placebo resulted in one additional patient achieving clinical response and remission, respectively. Future trials are needed to expand on these findings.
Short Description: This analysis assessed the potential clinical benefit-risk profile of MM120 (lysergide d-tartrate) in adults with GAD by calculating the number needed to treat (NNT), the number needed to harm (NNH), and likelihood to be helped or harmed (LHH) based on data from a phase 2b trial (NCT05407064).
Name of Sponsoring Organization(s): MindMed
