- Allakos shares plummeted almost 90% after the company on Tuesday said its lead experimental drug failed in two major studies.
- The California biotech was studying the medicine, called lirentelimab, in patients with disorders caused by the proliferation of immune system cells called eosinophils. One Phase 3 trial included patients with either eosinophilic gastritis or duodenitis, or a combination both, while a Phase 2/3 study focused on patients with eosinophilic esophagitis.
- In both trials, the drug appeared to have the effect on tissue sought by researchers but failed to significantly improve patient symptoms. The stock, which closed above $84 on Tuesday before the company released the study results, traded below $10 early Wednesday morning.
While Allakos isn't giving up on its lead drug, the study results clearly disappointed investors.
There's some kind of "disconnect" in the study results, Maury Raycroft, an analyst at Jefferies, wrote in a note to clients. It's possible the patients enrolled in the trial had diseases that weren't mainly caused by an excess of eosinophils; it's also possible the company's study designs were flawed, he wrote.
Craig Paterson, chief medical officer at Allakos, expressed surprise at the study outcomes and said his team will analyze the data to determine a path forward for the drug in eosinophilic gastrointestinal diseases. For now, the company plans to continue to develop the medicine for atopic dermatitis, chronic spontaneous urticaria and asthma, he said.
Analysts at both Jefferies and SVB Leerink cut their ratings on the stock on lower expectations for the drug. There are now few "meaningful near-term catalysts" for the company in the next year or so, Thomas Smith, of SVB Leerink, wrote in a note to investors.
Meanwhile, another would-be entrant into the market for eosinophilic esophagitis treatments got disappointing news on Tuesday as well. Japanese drugmaker Takeda said the Food and Drug Administration rejected its drug, TAK-721, and recommended another clinical study.
The company said it's assessing the FDA's complete response letter and deciding on next steps. A year ago, the drug's prospects looked rosy; Takeda said the FDA had granted it priority review, a process reserved for medicines that have the chance to offer significant advances in treatment.