Bayer cuts PhII orphan drug for acute respiratory distress syndrome as it ups R&D spending

Bayer has shuttered a Phase II program — that the EMA had designated an orphan drug — “for scientific reasons,” the German conglomerate disclosed in its half-year report.

The cut comes as Bayer reports pharma earnings is below the prior year — despite “stable sales” — due to “higher R&D investments in cell and gene therapy and chemoproteomics technologies, as well as in projects in advanced clinical development.”

Overall, the Q2 numbers were impacted by a sharp decline in glyphosate sales on the crop science side, even though the consumer health business showed some growth, Bayer said. Compared to the same quarter last year, group sales fell by 8.2% to $12 billion (€11 billion), including €4.924 billion from the agricultural business (down 18.5%), €4.557 billion from prescription medicines (matching prior year level) and €1.466 billion from self-care products (up 5.4%).

Bill Anderson

Bill Anderson is set to outline his vision for Bayer during his first earnings call as CEO after leaving Roche to take over from Werner Baumann.

The company decided in May not to pursue the orphan drug adrenomedullin pegol or PEG-ADM any further, according to the new update. A clinicaltrials.gov listing suggests that a Phase II study in acute respiratory distress syndrome has been terminated after the first part, which was comparing two doses of the drug against placebo.

Previously dubbed BAY 1097761, PEG-ADM comprises adrenomedullin, a human hormone, attached to a chain of polyethylene glycol, to make it last longer in the body. It is designed as an inhaled therapy delivered through a nebulizer with the hopes that it could reduce inflammation and keep blood vessels from leaking. The EMA granted it orphan status in 2020, soon after Bayer kicked off its Phase II study in Europe.

Bayer also reiterated several culls it made in the first quarter, including a Phase II BDKRB1 receptor antagonist for neuropathic pain and runcaciguat, a Phase II oral sGC activator being developed for chronic kidney disease. The company said it’s working with a follow-up compound to runcaciguat, named BAY3283142, which is currently finishing up Phase I.

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