Eli Lilly and Co.’s $1.1 billion acquisition of Dermira Inc. early last year is looking like a smart move after the company’s atopic dermatitis (AD) drug, lebrikizumab, hit all its targets in two phase III trials. Lebrikizumab is an interleukin-13 (IL-13) antagonist and is part of Lilly’s strategy to build a dermatology portfolio to compete in a market dominated by Sanofi SA and Regeneron Pharmaceutical Inc.’s Dupixent (dupilumab), which was the first injected antibody drug available for atopic dermatitis in 2017. Lilly picked up Dermira, of Menlo Park, Calif., along with lebrikizumab in January last year shortly after the FDA granted lebrikizumab fast track status, paving the way for a potential six-month review. Dupixent works in a different way, by inhibiting IL-4, but the path to approval for lebrikizumab is similar, involving two phase III trials with 75% skin clearance as the main benchmark for success.

Pfizer’s Ticovac approved by the FDA as tick-borne encephalitis vaccine

Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis (TBE). The approval came late on Aug. 13, the vaccine’s PDUFA date, and is the only FDA-approved TBE vaccine. In February, the FDA accepted the inactivated whole virus vaccine’s BLA from New York-based Pfizer and granted it a priority review. The CDC’s Advisory Committee on Immunization Practices will gather to discuss the new approval but has not yet set a date. TBE, which is not endemic to the U.S., primarily comes from the bite of flavivirus infected Ixodes ticks and is a brain and spin viral infection. It can be found in more than 35 Asian and European countries.

Interim phase III IgAN data with sparsentan lift Travere shares

Travere Therapeutics Inc. shares (NASDAQ:TVTX) were trading midday at $18.78, up $3.34, or 21%, on positive top-line interim results from the pivotal phase III Protect study with sparsentan for IgA nephropathy (IgAN). The PROTECT Study met its prespecified interim primary efficacy endpoint with statistical significance, turning up a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment – 49.8% – compared to the active control irbesartan, an AT1 angiotensin II receptor binder (p<0.0001). Sparsentan, a dual-acting antagonist of the endothelin type A and angiotensin II type 1 receptors, has been generally well-tolerated so far, consistent with previous findings, San Diego-based Travere said. In IgAN, the IgA protein accumulates in the kidneys and causes damage.

Innovent’s sintilimab combo heads toward sNDA filing in gastric cancer

Innovent Biologics Inc.’s PD-1 inhibitor, sintilimab, has met the primary endpoint of overall survival in a phase III trial for the treatment of gastric cancer, delivering a statistically significant improvement in the measure vs. placebo. Both arms included chemotherapy. The randomized, double-blind study evaluated first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Following the outcome, Innovent plans to file an sNDA with China’s NMPA, it said.

Beckley Psytech raises $80M in upsized B round as first psychedelic programs enter the clinic

DUBLIN – Beckley Psytech Ltd. raised $80 million in an oversubscribed series B round to move its early stage pipeline of psychedelic therapies into the clinic and to continue research on novel compounds with enhanced properties. The financing is further evidence of the strong investor interest in the broad field of harnessing the effects of psychedelic drugs for therapeutic properties. It follows the recent IPOs of Berlin-based Atai Life Sciences NV and Dublin-based GH Research plc, as well as a large follow-on offering completed during the last quarter by London-based Compass Pathways plc. “There’s been a long period of building up a compelling scientific evidence base over the past couple of decades,” Cosmo Feilding Mellen, CEO of Oxford, U.K.-based Beckley Psytech, told BioWorld. “The science has been gradually eroding the stigma around these compounds,” he said.

Inmagene gains rights to Syk inhibitor fostamatinib in Chinese markets

Inmagene Biopharmaceuticals Co. Ltd. has licensed rights from Kissei Pharmaceutical Co. Ltd. to develop and commercialize the spleen tyrosine kinase (Syk) inhibitor fostamatinib for all potential indications in China. It will pay Kissei an undisclosed up-front payment plus development and commercialization milestone payments for the drug. Initially developed by Rigel Pharmaceuticals Inc., fostamatinib was first approved in the U.S. as Tavalisse for the treatment of patients with chronic immune thrombocytopenia in May 2018. It has since won approval in Europe and Canada.

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