Research & Development · Trials

Clinical trials.

Safety and tolerability across the LM11A-31 Phase 1 and Phase 2a program.

Safety Profile

Favorable across all clinical studies.

Overall Safety

No ARIA. No brain edema.

Across three clinical studies and 287 treated patients, LM11A-31 was safe and tolerable with no Amyloid-Related Imaging Abnormalities or brain edema.

Phase 1 Studies

Five mild, drug-related events.

The only drug-related adverse events reported were flatulence (3), headache (1), and dizziness (1) — all mild.

Phase 2a Tolerability

Comparable to placebo.

Treatment-emergent AEs occurred in 62% of LM11A-31 patients vs. 51% on placebo, with a low 8.7% study discontinuation rate.

Most Common AEs

Transient, mild to moderate.

The most common treatment-emergent adverse events — diarrhea, nasopharyngitis, headache, and eosinophilia — were transient and mild to moderate in severity.

Phase 2a Adverse Events

Treatment-emergent adverse events by dose arm.

Preferred term
Placebo (N=81)
n (%)
LM11A-31 200 mg BID (N=78)
n (%)
LM11A-31 400 mg BID (N=83)
n (%)
Preferred term TEAEs
Placebo (N=81)
n (%) 41 (50.6)
LM11A-31 200 mg BID (N=78)
n (%) 46 (59.0)
LM11A-31 400 mg BID (N=83)
n (%) 54 (65.1)
Drug relationship
Preferred term Related
Placebo (N=81)
n (%) 8 (9.9)
LM11A-31 200 mg BID (N=78)
n (%) 12 (15.4)
LM11A-31 400 mg BID (N=83)
n (%) 13 (15.7)
Preferred term Not related
Placebo (N=81)
n (%) 36 (44.4)
LM11A-31 200 mg BID (N=78)
n (%) 41 (52.6)
LM11A-31 400 mg BID (N=83)
n (%) 48 (57.8)
Intensity
Preferred term Mild
Placebo (N=81)
n (%) 32 (39.5)
LM11A-31 200 mg BID (N=78)
n (%) 40 (51.3)
LM11A-31 400 mg BID (N=83)
n (%) 46 (55.4)
Preferred term Moderate
Placebo (N=81)
n (%) 11 (13.6)
LM11A-31 200 mg BID (N=78)
n (%) 11 (14.1)
LM11A-31 400 mg BID (N=83)
n (%) 24 (28.9)
Preferred term Severe
Placebo (N=81)
n (%) 3 (3.7)
LM11A-31 200 mg BID (N=78)
n (%) 2 (2.6)
LM11A-31 400 mg BID (N=83)
n (%) 5 (6.0)
Preferred term Serious TEAEs
Placebo (N=81)
n (%) 4 (4.9)
LM11A-31 200 mg BID (N=78)
n (%) 2 (2.6)
LM11A-31 400 mg BID (N=83)
n (%) 7 (8.4)
Most common TEAEs (transient)
Preferred term Nasopharyngitis
Placebo (N=81)
n (%) 2 (2.5)
LM11A-31 200 mg BID (N=78)
n (%) 5 (6.4)
LM11A-31 400 mg BID (N=83)
n (%) 10 (12.0)
Preferred term Diarrhea
Placebo (N=81)
n (%) 1 (1.2)
LM11A-31 200 mg BID (N=78)
n (%) 1 (1.3)
LM11A-31 400 mg BID (N=83)
n (%) 11 (13.3)
Preferred term Headache
Placebo (N=81)
n (%) 2 (2.5)
LM11A-31 200 mg BID (N=78)
n (%) 5 (6.4)
LM11A-31 400 mg BID (N=83)
n (%) 5 (6.0)
Preferred term Eosinophilia
Placebo (N=81)
n (%) 0
LM11A-31 200 mg BID (N=78)
n (%) 5 (6.4)
LM11A-31 400 mg BID (N=83)
n (%) 5 (6.0)