Smartphone Typing Metrics Show High Reliability as Digital End Points in Phase 2b LUMA Study of BIIB122

A newly presented analysis from the phase 2b LUMA study (NCT05348785) of BIIB122/DNL151 (Biogen/Denali Therapeutics), an investigational LRRK inhibitor, demonstrated that multiple sensor-derived measures from Konectom’s smartphone-based typing test showed high reliability in patients with Parkinson disease (PD). These findings suggest that keystroke dynamics may capture aspects of motor and nonmotor function during activities of daily living (ADL) in PD and could complement other ADL assessments in the LUMA study.¹

In an analysis of baseline data from 200 patients with PD, sensor-derived measures showed high reliability across in-clinic and remote assessment pairs, with 93% of measure combinations achieving an intraclass correlation coefficient (ICC) of 0.70 or greater and 53% demonstrating a minimal detectable change at the 95% confidence interval (MDC95%) of 0.2 or less. Results showed that Reaction Time (ICC, 0.60-0.81; MDC95%, 0.17-0.26), Letter Interval (ICC, 0.66-0.86; MDC95%, 0.18-0.28), and Number of Correct Words (ICC, 0.71-0.84; MDC95%, 0.22-0.29) showed the highest reliability.

In the current analysis, presented at the 2026 AD/PD International Conference on Alzheimer’s and Parkinson’s Diseases, held March 17-21 in Copenhagen, Denmark, the Konectom smartphone application assessment battery, which includes an active typing task (copying words), was evaluated as an exploratory end point. The study, presented by lead author Roy Llorens Arenas, MD, the medical director in Clinical Development for Movement Disorders at Biogen, aimed to identify the most reliable sensor-derived measures from the typing task using baseline data from the LUMA trial as part of an initial validation effort.

Phase 2 LUMA Study

For context, the LUMA study is an ongoing phase 2b double-blind, placebo-controlled trial that includes 650 participants between the ages of 30 and 80 years with early-stage PD who are randomly assigned to 225 mg of oral BIIB122/DNL151 or placebo once daily for a minimum of 48 weeks and a maximum of 144 weeks. To understand whether BIIB122/DNL151 slows the worsening of symptoms in treated patients, researchers will use the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) parts II and III as primaru outcomes.²

READ MORE: Autologous Cell Therapy Sasineprocel Demonstrates 12-Month Safety, Engraftment in Parkinson Disease

For the current analysis, researchers evaluated baseline data from randomly selected trial participants (mean age, 60.7 [SD, 8.88] years; mean MDS-UPDRS Part III score, 18.4 [SD, 7.89]). Ten complementary smartphone-based assessments were administered at baseline, including 2 in-clinic evaluations and remote testing conducted once daily over 4 weeks. In the Copying Words task, participants were instructed to type as many words as possible in 60 seconds as they appeared on the screen, with adaptive word length.

All told, 17 sensor-derived measures were evaluated as candidate outcomes. Reliability was assessed across 15 paired assessments using ICC and minimal detectable change at MDC95%, relative to the sample range, to identify the most reliable measures. Investigators noted that further analyses are planned to assess the sensitivity of these measures to disease progression relative to established clinical anchors.

Phase 2a BEACON Study

Denali noted that the clinical data readout from the global phase 2b LUMA study is anticipated in mid-2026.³ BIIB122/DNL151 is also being evaluated in the phase 2a BEACON study (NCT06602193) in patients with LRRK2-associated PD. In BEACON, approximately 50 participants with genetically confirmed LRRK2 pathogenic mutations will receive daily oral dosing of BIIB122/DNL151, with investigators assessing safety and biomarker outcomes. The study includes a 3-month double-blind treatment period followed by an open-label extension.

Phase 3 LIGHTHOUSE Study

In June 2023, Biogen and Denali announced the discontinuation of a portion of the clinical development program for BIIB122/DNL151, specifically the phase 3 LIGHTHOUSE study (NCT05418673), which was initiated in September 2022.⁴ The companies stated that the decision was based on the study’s complexity, including its long timeline, with anticipated completion in 2031. They noted that the modification was not due to safety or efficacy findings and affirmed their continued commitment to advancing the development of BIIB122/DNL151.

Click here for more of our 2026 AD/PD coverage.

REFERENCES
1. Arenas RL, Bartholome E, Bernasconi C, et al. Smartphone-Based Measurement of Keystroke Dynamics in the Phase 2b LUMA Trial in Parkinson’s Disease. Presented at: 2026 AD/PD International Conference on Alzheimer’s and Parkinson’s Diseases; held March 17-21; Copenhagen, Denmark. Abstract 3105.
2. Denali Therapeutics and Biogen announce initiation of phase 2b study of LRRK2 inhibitor in Parkinson disease. News release. Biogen. May 31, 2022. Accessed March 19, 2026. https://investors.biogen.com/news-releases/news-release-details/denali-therapeutics-and-biogen-announce-initiation-phase-2b
3. Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights. News release. Denali. February 26, 2026. Accessed March 19, 2026. https://investors.denalitherapeutics.com/news-releases/news-release-details/denali-therapeutics-reports-fourth-quarter-and-full-year-2025
4. Statement: Biogen Provides Update on Parkinson’s Disease Clinical Development Program. News release. Biogen. June 5, 2023. Accessed March 19, 2026. https://investors.biogen.com/news-releases/news-release-details/statement-biogen-provides-update-parkinsons-disease-clinical