Pfizer puts the pressure on Eli Lilly's JAK inhibitor Olumiant with new data in alopecia areata
As Eli Lilly looks to secure a win for its blockbuster Olumiant in alopecia areata, going where no JAK inhibitor has gone before, Pfizer is coming up from behind with Phase IIb/III results suggesting its own candidate can help regrow hair lost due to the autoimmune disease.
On Wednesday, Pfizer unveiled topline results from the ALLEGRO trial, which enrolled 718 patients 12 years and older with alopecia areata, a condition that can cause sudden, severe and patchy hair loss. While the patients’ episodes of alopecia areata varied in length, they all had one thing in common: They had lost at least half the hair on their scalps.
The participants received varying doses of Pfizer’s JAK inhibitor ritlecitinib — 50 mg or 30 mg (with or without one month of initial treatment with once-daily 200 mg doses of ritlecitinib), or 10 mg — or a placebo.
After six months, a significantly larger proportion of patients in the 50 mg and 30 mg dose groups (with or without the initial treatment) were missing only 20% of their hair or less, compared to placebo, according to Pfizer. The company didn’t release any hard numbers, but says it’s diving right into a 24-week extension study.
“We are pleased by these positive results for ritlecitinib in patients with alopecia areata, a devastating and complex autoimmune disease for which there are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency approved treatments,” Michael Corbo, chief development officer of inflammation and immunology in Pfizer’s global product development unit, said in a statement.
Back in April, Eli Lilly reported that 35% of the subjects who received 4 mg doses of baricitinib achieved 80% or more scalp hair coverage, versus 22% in the 2 mg arm. At the time, the company said it was shooting to file an NDA in the second half of this year.
The FDA has become increasingly skeptical of JAK inhibitors since first approving Pfizer’s Xeljanz in 2012, recently delaying decisions for a slate of supplemental NDAs to get a closer look at safety data, including Olumiant and AbbVie’s Rinvoq in atopic dermatitis. Last summer, the agency turned down Gilead’s rheumatoid arthritis candidate filgotinib, demanding to see more safety data. And earlier this year, Xeljanz failed a six-year safety study, showing that patients who took the drug experienced more cardiovascular events and higher rates of cancer than those who took Humira or Enbrel.
Ritlecitinib’s safety profile was consistent with previous studies, Pfizer said, noting that the occurrence of side effects was similar across all treatment groups. The most common ones were colds, headaches, and upper respiratory tract infections. There were no major adverse cardiac events or deaths in the trial, according to the pharma company. However, two patients in the 50 mg group discontinued the study due to breast cancer, and one patient in the same group developed a pulmonary embolism.
Pfizer and Eli Lilly aren’t the only two drugmakers duking it out for an indication in alopecia areata. Concert Pharmaceuticals snagged a breakthrough designation for its JAK inhibitor last summer, and launched a second Phase III trial in May. Back in 2018, Aclaris Therapeutics failed a Phase II study with an alopecia areata candidate it licensed from Rigel Pharma, finding that the molecule didn’t improve scalp hair coverage compared to placebo. That candidate is no longer in the company’s pipeline.