Shares of Skye Bioscience Inc. (NASDAQ:SKYE) were trading at $9.20, down $1.74, or almost 16% after the company said the phase IIa trial with SBI-100 ophthalmic emulsion in patients with primary open-angle glaucoma or ocular hypertension missed its primary endpoint of lowering intraocular pressure. The San Diego-based firm will discontinue clinical development and spending related to the compound as well as the ophthalmology pipeline. Resources are shifting to the metabolic program, which includes the CB1 inhibitor nimacimab, due to start a phase II trial in obesity during the third quarter of this year. The moves extend Skye’s operating runway into 2027.
Alzheimer’s space advances with third adcom
Today marks the third time the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting to discuss an amyloid-targeting monoclonal antibody (MAb) intended to treat Alzheimer’s. The first two meetings focused on MAbs developed by Biogen Inc. and Eisai Co. Ltd. This time, Eli Lilly and Co. is presenting the data for donanemab, a MAb that’s been in development for two decades. Besides discussing the safety benefit of the biologic being proposed to treat patients in early symptomatic Alzheimer’s, the panel is looking at how unique elements of Lilly’s clinical trials could be translated into real-world clinical practice.
Moderna’s combo flu/COVID-19 vaccine hits phase III endpoints
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing. Comprising components of seasonal flu vaccine mRNA-1010 and next-generation COVID-19 vaccine mRNA-1283, both of which previously hit phase III endpoints when tested independently, the combo vaccine elicited higher immune responses in adults 50 and older when compared to licensed individual vaccines. The phase III readout came only a few days after Cambridge, Mass.-based Moderna submitted an application to the U.S. FDA seeking review of the 2024-2025 formula of approved COVID-19 vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1.
Abtis tapping ADC market with Claudin18.2-targeting AT-211
Abtis Co. Ltd., Dong-A ST’s newly incorporated subsidiary since December 2023, is making headway with its leading Claudin18.2-targeting antibody-drug conjugate (ADC) candidate, AT-211, according to Abtis CEO Taedong Han. “About 80% of gastric cancers do not have HER2 overexpression, but 77% overexpressed Claudin18.2,” Han told Bio Korea 2024 audience members on May 9, stressing that AT-211 was found to be highly potent against cancer cells expressing Claudin18.2 in ADC cell viability studies. With pharmacokinetics studies further highlighting its linker to be highly stable in vivo, according to Han, AT-211 is showing higher stability than Astellas Pharma Inc.’s zolbetuximab.
Lotus acquires Teva Thailand to build Southeast Asian footprint
Lotus Pharmaceutical Co. Ltd. is acquiring the Thailand business and commercial entity of Teva Pharma Thailand to expand its footprint in Southeast Asia. Although terms of the deal were not disclosed, a filing with the Taiwan Stock Exchange revealed that Lotus will pay NT$1.5 billion (US$46.2 million) to acquire the Thailand franchise of Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel. As its first deal in Southeast Asia, Taipei, Taiwan-headquartered Lotus expects Thailand to become a hub for its Southeast Asian expansion. The Teva Thailand entity will become a wholly owned subsidiary of Lotus, and Lotus will undertake the sales and marketing of Teva’s existing products.