Today, a brief rundown of news involving Alkermes and Cue Biopharma, as well as updates from Eli Lilly, AbbVie and Johnson & Johnson that you may have missed.
A new kind of sleep drug has shown early signs it may help treat attention-deficit hyperactivity disorder, or ADHD. Known as ALKS 7290 and discovered by Alkermes, the drug is one of several in clinical testing that amplify the protein orexin-2 and are initially being developed for narcolepsy. Alkermes said Monday that ALKS 7290 demonstrated “proof of concept” in an early-stage trial in ADHD, with treatment leading to “dose-dependent, clinically meaningful improvements” on exploratory measures evaluating the severity of symptoms. The findings are “promising but not that surprising,” wrote Leerink Partners analyst Marc Goodman. The “key question is how well they will work,” given the widespread availability of effective generics, he added. A Phase 2 study is underway, with results expected in 2027.
Cue Biopharma said Sunday that a newly in-licensed drug had succeeded in a Phase 2 trial in chronic spontaneous urticarias in China. When compared to a placebo after 12 weeks, all three doses of Cue’s drug CUE-221 helped a higher proportion of patients eliminate their urticarias, or hives. The results also suggested CUE-221’s effects might last beyond their final dose at 16 weeks, too, “supporting differentiation” compared to the widely used therapy Xolair, wrote Jefferies analyst Maury Raycroft. Still, Cue shares lost nearly a quarter of their value on Monday in a sell-off that Raycroft described as “unwarranted.” Cue grabbed rights to the therapy in an April deal with China-based biotech Ascendant Life Sciences.
The Food and Drug Administration has expanded use of Eli Lilly’s breast cancer pill Inluriyo, the company said Friday. The agency originally approved Inluriyo as a monotherapy in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. On Friday, the FDA greenlit use of Inluriyo alongside another Lilly medication, Verzenio, in a similar setting. Both clearances were based on results from the same trial, “EMBER-3,” in which the Inluriyo-Verzenio combination delayed tumor progression by 11.1 months compared to 5.5 months for standard hormone-suppressing therapies in people with so-called ESR1 mutations.
Caplyta, a psychiatric medicine Johnson & Johnson acquired in a nearly $15 billion deal last year, has succeeded in another late-stage study. When compared to a placebo, the drug reduced the rate of manic symptoms after three weeks in people with bipolar I disorder. Improvements were seen in as soon three days, and Caplyta’s safety was “consistent” with what’s been observed in previous testing, according to J&J. Originally developed by Intra-Cellular Therapies, Caplyta is approved to treat schizophrenia, bipolar depression and major depressive disorder. It’s not yet cleared to treat “manic episodes,” the sudden behavioral swings that are a defining feature of bipolar I disorder. A second Phase 3 study is underway.
AbbVie will work with Iambic to unearth new small molecule medicines for cancer, immune diseases and neurological conditions. AbbVie didn’t provide specific financial details in a Monday statement, but said that the multiyear partnership will involve using Iambic’s AI capabilities to “accelerate” the discovery of therapies with “first-in-class and best-in-class potential.” In addition to the AbbVie deal, Iambic has recently formed alliances with Takeda, Bayer, Lundbeck and Jazz Pharmaceuticals.
