Pfizer lays out slate of Ph3 successes for its crucial RA program

Pfizer ($PFE) outlined a slate of late-stage successes for tofacitinib, a crucial drug designed to treat rheumatoid arthritis. Tapped as a likely blockbuster in the event that Pfizer can successfully wrap its Phase III work, investigators announced that the drug hit all primary endpoints in two late-stage clinical trials.

Patients taking the oral RA drug at both five and ten milligrams in both studies demonstrated reduced signs and symptoms of RA, according to Pfizer. But only top-line results were announced, with the data being held in reserve for a scientific meeting.

The pharma giant's ORAL Standard trial completed 12 months of treatment for patients with moderate-to-severe active rheumatoid arthritis who had an inadequate response to methotrexate. The ORAL Step trial completed six months of treatment in patients with moderate-to-severe active RA who had an inadequate response to a TNF inhibitor.

No new safety signals emerged in the ORAL Standard and ORAL Step studies, Pfizer reported. "The efficacy and safety profile of tofacitinib in these studies remains consistent with that seen previously in the clinical program."

Tofacitinib is one of Pfizer's most important late-stage programs, a point which was dramatically underscored recently when its stock took a three percent hit after reports circulated that four patients died in one of its studies. Pfizer later clarified that only one of the deaths appeared to be drug related. The RA drug is part of a new class of drugs known as JAK inhibitors, which tackle protein signaling involved in the body's inflammatory responses.

Pfizer has mounted six late-stage studies of tofacitinib as it attempts to break a long cycle of late-stage failures. Ranked alongside the cancer treatment crizotinib as a key experimental program, investigators are also comparing the treatment to Humira, an approved drug that Pfizer hopes to compete against. Some analysts are particularly anxious to find out how the comparative data plays out, noting that the results could have a big impact on the drug's ability to earn fresh revenue. 

- check out the Pfizer release
- here's the Reuters report

Suggested Articles

MicuRx nabbed $7.78 million from a nonprofit focused on antimicrobial resistance to push its third antimicrobial program into human trials.

The FDA has handed Scholar Rock a rare pediatric disease designation voucher, which can allow the biotech a speedy review of its SMA med.

The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gene therapy on clinical hold pending further assessment of the risk of its delivery device.