Xenon Pharmaceuticals Inc. rolled out top-line results from the phase II proof-of-concept X-Nova trial testing the efficacy, safety, and tolerability of 10 mg and 20 mg of Kv7 potassium channel opener XEN-1101 in 168 patients with moderate to severe major depressive disorder (MDD). The primary endpoint of the study was a change in the Montgomery-Åsberg Depression Rating Scale at the sixth week. The mean reduction was 13.90 in the placebo group, 15.61 in the XEN-1101 10-mg arm, and 16.94 in the XEN-1101 20-mg cohort. The trial also turned up a clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN-1101 20-mg group (p=0.135). The drug – in the works for epilepsy as well as MDD – was even better tolerated than expected, officials said. Shares of Vancouver, British Columbia-based Xenon (NASDAQ:XENE) were trading midday at $32.49, up $3.52, or 12%.

Another ‘homerun’ for Dupixent as Sanofi, Regeneron plan year-end filing in COPD

Hailing positive results from the first biologic for chronic obstructive pulmonary disease (COPD) to succeed in two phase III trials, Regeneron Pharmaceuticals Inc. and Sanofi SA announced plans to submit a supplemental BLA for Dupixent (dupilumab), a monoclonal antibody targeting the interleukin-4 (IL-4) and IL-13 pathways, by the end of 2023. Data from the Notus study, reported roughly eight months after the positive Boreas study, showed Dupixent significantly reduced exacerbations by 34% and improved lung function in patients with uncontrolled COPD and evidence of type 2 inflammation.

GSK’s Blenrep makes a comeback in multiple myeloma

GSK plc is looking at a comeback for Blenrep (belantamab mafodotin). Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma (MM) drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market. GSK then placed a bet on the phase III Dreamm-7 study with Blenrep as a second-line treatment for relapsed or refractory MM. The study hit its primary endpoint of progression-free survival as a combination therapy with bortezomib plus dexamethasone. Before it was pulled, Blenrep was predicted to produce peak annual sales of £3 billion (US$3.56 billion) for the London-based company if approved in earlier stages of the disease.

OIG asked to dive deeper into US vertical integration trend

With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in setting high list prices for patients. In one of the more recent congressional efforts to identify those with a finger in the drug pricing pie, Sens. Elizabeth Warren (D-Mass.) and Mike Braun (R-Ind.) asked the Health and Human Services’ Office of Inspector General (OIG) to investigate whether the vertical integration of the drug delivery system is an end-run for payers around the congressionally mandated Medical Loss Ratio that requires health insurers to spend at least 80% or 85% of health care premiums on medical claims.

Innovent on a roll: China accepts two new NDAs for lung cancer

In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor. Innovent raised HKD$2.37 billion (US$306 million) in September 2023 to advance its late-stage pipeline, which includes more than 30 innovative drug candidates, eight of which are either under NDA review or in pivotal registrational trials.

Holiday notice

BioWorld's offices were closed in observance of Thanksgiving in the U.S. No issues were published Thursday, Nov. 23, or Friday, Nov. 24.

Also in the news

Aeglea, Aim Immunotech, Akiram, Alladapt, Anheart, Arvinas, Biodexa, Cellcentric, CNS, Concentra, Entrada, Fluoguide, Immutep, Index, Ingeneron, Innovent, Merz, Nexcella, Ocuphire, Rakovina, RVL, Scisparc, Seelos, Sosei Heptares, Spyre, Sumitomo, Theseus, TME, Xbrane