Sleep Drug Candidate Shows Potential in ADHD, Achieving Proof of Concept in Early Trial

An investigational drug being developed to treat sleep disorders may also be effective for attention-deficit/hyperactivity disorder (ADHD), according to an early-stage clinical trial.

Alkermes said the orexin-2 protein activator ALKS 7290 achieved proof of concept in an early-stage ADHD trial, BioPharma Dive reported on the 21st (local time).

The drug produced clinically meaningful, dose-related improvement on an exploratory measure of symptom severity. Mark Goodman, an analyst at Leerink Partners, called the results “promising but not particularly surprising,” adding that with effective generics widely used, “the key is how well it works.” A phase 2 trial is underway, with results expected in 2027.

Cue Biopharma said on the 20th that its licensed drug CUE-221 succeeded in a phase 2 trial for chronic spontaneous urticaria conducted in China. At 12 weeks, a higher proportion of patients in each of the three dose groups had no hives compared with placebo.

Jefferies analyst Maury Raycroft said the effect could persist at 16 weeks, potentially differentiating the drug from widely used Xolair. Cue’s stock, however, fell about 25% on the 21st, and Raycroft called the sell-off “unfounded.” Cue secured rights to the treatment in an agreement with Chinese biotech company Ascendent Life Science last April.

Eli Lilly said on the 18th that the use of its breast cancer drug Inluriyo has been expanded. The U.S. Food and Drug Administration (FDA) approved Inluriyo in combination with Verzenio for adults with metastatic, estrogen receptor-positive, HER2-negative breast cancer whose disease has progressed after hormone therapy.

The approval was based on results from the EMBER-3 trial. Among patients with ESR1 mutations, the Inluriyo-Verzenio combination delayed tumor progression for 11.1 months, compared with 5.5 months with standard hormone suppression therapy.

Johnson & Johnson (J&J) said its psychiatric drug Caplyta succeeded again in a late-stage trial. In a study of patients with bipolar I disorder, the drug reduced the incidence of manic symptoms compared with placebo after 3 weeks, with improvement appearing in as little as 3 days. J&J said the safety profile was consistent with that in previous trials.

Caplyta is approved to treat schizophrenia, bipolar depression and major depressive disorder, but not “manic episodes,” a defining feature of bipolar I disorder. A second phase 3 trial is underway.

AbbVie has partnered with AI drug discovery company Iambic to identify small-molecule drugs for cancer, immune diseases and neurological disorders. In a statement on the 21st, AbbVie did not disclose specific financial terms but said the multiyear partnership would use Iambic’s AI capabilities to accelerate the discovery of treatments with “first-in-class” and “best-in-class” potential. Iambic has also recently partnered with Takeda, Bayer, Lundbeck and Jazz Pharmaceuticals.