- Less than two months after downplaying a pair of late-stage clinical failures for an experimental asthma treatment, Novartis said Monday it will stop developing fevipiprant in the lung condition after two additional studies fell short of goal.
- Novartis said a pooled analysis "did not meet the clinically relevant threshold" for reducing asthma attacks by more than placebo after a year of treatment. More than 1,700 patients were enrolled in these two latest studies.
- The Swiss pharma did not provide detailed clinical results, which, when disclosed, could give a gauge of whether other similar drugs in asthma might succeed. One of those is Gossamer Bio's lead drug, and the small California biotech saw its stock drop by more than one-third Monday.
Earlier this month, Novartis highlighted fevipiprant as one of more than 25 potential blockbusters in its pipeline. After another pair of disappointing clinical results, the pharma's ambitions for the drug will be pared down.
While Monday's announcement signals the end for fevipiprant in asthma, Novartis will continue an ongoing trial of the drug in nasal polyposis. The pharma also highlighted its hopes for other late-stage respiratory medicines, including the inhaled combinations QVM149 and QMF149 in moderate-to-severe asthma.
For Gossamer, detailed data from fevipiprant would likely weigh heavily on GB001, its lead drug in the same drug class. Gossamer has tailored an ongoing Phase 2b asthma study to focus on the patient population with high levels of eosinophil, a type of white blood cell that typically fights infections.
Novartis tracked eosinophil counts in enrolled patients so that two-thirds of study participants had eosinophil levels at or above 250 cells per microliter. The primary endpoint focused on this population, but Novartis avoided explicitly stating whether or not fevipiprant missed statistical significance on that metric. No data on the rate of asthma exacerbations were disclosed, either.
Some sell-side analysts covering Gossamer Bio argued GB001 could still be successful in a Phase 2b asthma study, set to produce topline results in 2020.
SVB Leerink analyst Joseph Schwartz did not adjust a 75% probability of success and $1.1 billion in peak sales for GB001 in asthma, pointing out the drug's "superior pharmacology" in a Monday note to investors.
Cantor Fitzgerald's Eliana Merle also wrote Gossamer's drug could still be successful, particularly given the lack of specific data from Novartis. Both analysts recommend investors buy Gossamer stock with one-year price targets of roughly double its current value.