Merck has announced positive phase 3 results for Capvaxive, its 21-valent pneumococcal conjugate vaccine, in children and adolescents with chronic medical conditions that increase their risk of pneumococcal disease.

Findings from the STRIDE-13 trial were presented at the 6th ESCMID Conference on Vaccines in Lisbon. The study compared Capvaxive with PPSV23 in patients aged two to under 18 years who had completed a primary paediatric pneumococcal vaccination regimen.

Capvaxive elicited immune responses to all 21 serotypes included in the vaccine. It was noninferior to PPSV23 for the 12 shared serotypes and superior for the nine unique serotypes, based on serotype-specific opsonophagocytic activity geometric mean titres measured 30 days post-vaccination.

Safety data showed comparable rates of adverse events between the two groups. Systemic and serious vaccine-related events were similar, supporting the tolerability of Capvaxive in this vulnerable population.

Dr Rotem Lapidot, chief of Paediatric Infectious Diseases at Rambam Health Care Campus and trial investigator, said: “Children and adolescents living with chronic medical conditions are at increased risk of pneumococcal disease and offering them additional protection is essential.

“Results from STRIDE-13 demonstrate the potential of Capvaxive to deliver protection for these vulnerable populations, who may benefit from additional pneumococcal disease coverage by including serotypes not contained in other approved pneumococcal infant regimens.”

Merck plans to share the STRIDE-13 data with global regulatory authorities.

Eisai has presented new clinical data for its investigational orexin 2 receptor agonist E2086 at the World Sleep 2025 congress in Singapore.

The phase 1b trial showed that once-daily dosing may improve daytime wakefulness in people with narcolepsy type 1.

The randomised, double-blind, single-dose, multiple crossover study was conducted in the US and Canada. It compared E2086 with placebo and modafinil in 21 patients meeting criteria for narcolepsy type 1.

Participants received one of five treatments shortly after waking. Efficacy was assessed using the Maintenance of Wakefulness Test (MWT) and the Karolinska Sleepiness Scale (KSS).

All doses of E2086 significantly increased sleep latency compared with placebo (P<0.0001) and modafinil (5mg: P=0.0009; 10mg and 25mg: P<0.0001). KSS scores also showed higher alertness for all doses versus placebo (P<0.0001), with 10mg and 25mg outperforming modafinil (P<0.0001).

Treatment-emergent adverse events followed a dose-dependent trend. The most frequent were increased urinary frequency, nausea, dizziness and urinary urgency.  No serious adverse events were reported and none led to discontinuation.

Katsutoshi Ido, Chief Scientific Officer at Eisai, said: “At World Sleep 2025, we presented data supporting the potential of E2086 to improve daytime wakefulness in people diagnosed with narcolepsy type 1.”

Eisai has previously developed Dayvigo, an orexin receptor antagonist for insomnia. E2086, by contrast, activates orexinergic neurons to promote wakefulness. The company aims to expand its contribution to sleep disorder treatment through this new candidate.

Further investigation is planned to confirm E2086’s efficacy and safety in broader narcolepsy populations.