IHL-42X Performs in Phase 2 RePOSA Study, ATH434 Eyes Phase 3 Multiple System Atrophy Trial, 4-Year Data on Lecanemab Unveiled

WATCH TIME: 4 minutes

Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

Newly announced findings from the phase 2 RePOSA trial (NCT06146101) showed that IHL-42X (Incannex), an investigational therapy for obstructive sleep apnea (OSA), led to clinically meaningful improvements in key end points, including both objective and subjective aspects of OSA. Based on these findings, preparations for an End-of-Phase 2 meeting with the FDA are underway, with the goal to optimize a phase 3 trial design and regulatory strategy. RePOSA included 121 adult patients with moderate to severe OSA who were randomly assigned to either high- or low-dose IHL-42X, or placebo, for a 28-day treatment period. At the conclusion of that period, investigators observed statistically significant reductions in percent change of Apnoea-Hypopnea Index (AHI), the primary end point, in both the low- and high-dose IHL-42X groups relative to placebo (P <.05).

Newly announced data from an open-label phase 2 trial (NCT05864365) showed that investigational ATH434 (Alterity Therapeutics) led to significant therapeutic impacts in patients with multiple system atrophy (MSA), including on biomarker end points and orthostatic function, over a 12-month period. The findings mark the second positive phase 2 study in MSA for ATH434, further adding to the agent’s treatment profile. Otherwise known as the ATH434-202 trial, this open-label study featured 10 patients with the disease who received 75 mg of ATH434 twice daily for 12 months. At the conclusion of the treatment period, study investigators recorded mean increases of 3.5 (SD, 4.7) points on Modified Unified MSA Rating Scale Part I (UMSARS I), with 3 of 7 (43%) patients who completed the study demonstrating stable UMSARS scores.

Newly presented data from the open-label extension (OLE) of the phase 3 Clarity AD trial (NCT03887455) provided greater context on the efficacy and safety of lecanemab (Leqembi; Eisai), an FDA-approved treatment for early-stage Alzheimer disease (AD), over a 4-year period. Presented at the 2025 Alzheimer’s Association International Conference (AAIC), held July 27-31, in Toronto, Canada, early-stage patients–who were identified through MK6240 tracer–gained the most from lecanemab treatment. According to a release from Biogen, after 4 years of treatment, 69% of patients identified through this optional tau substudy either improved or had no decline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) cognitive and functional domains, a quantitative scale of dementia severity.

For more direct access to expert insight, head to NeurologyLive.com. This has been Neurology News Network. Thanks for watching.