Pfizer Inc. (PFE) recently presented encouraging data on its rheumatoid arthritis candidate tofacitinib (formerly known as tasocitinib). Tofacitinib met its primary endpoint in the ORAL Sync phase III study (A3921046), which was conducted on patients suffering from moderate-to-severe rheumatoid arthritis. Results showed that compared to placebo, tofacitinib achieved a statistically significant reduction in signs and symptoms of rheumatoid arthritis.
The safety profile of the candidate was found to be consistent with previous results with no new safety signals being detected. Pfizer intends to present full safety and efficacy data at a scientific meeting.
Earlier, in November 2010, Pfizer had reported results from a late-stage trial (ORAL Solo – 1045) on tofacitinib in patients with signs and symptoms of moderate to severely active rheumatoid arthritis. The study met two primary endpoints after three months of treatment with tofacitinib.
The candidate demonstrated a statistically significant reduction in the signs and symptoms of moderate to severely active rheumatoid arthritis and an improvement in physical function of the patients as compared with placebo.
Although patients in the tofacitinib arm experienced a higher rate of disease remission compared with placebo, the results were not statistically significant.
Pfizer had also reported data from an ongoing phase II/III trial (ORAL Sequel – 1024) on tofacitinib. The study demonstrated results consistent with an earlier trial and showed sustained efficacy over 24 months of treatment with tofacitinib when administered as monotherapy or in combination with methotrexate.
Tofacitinib is a novel, oral Janus kinase (JAK) inhibitor which, once approved, will compete with products like Abbott’s (ABT) Humira, Johnson & Johnson’s (JNJ) Remicade and Simponi. Being an oral treatment, tofacitinib could have an edge over existing injectable therapies.
In addition to evaluating tofacitinib for the treatment of rheumatoid arthritis, Pfizer is studying the candidate for other indications including psoriasis, Crohn’s disease, ulcerative colitis and renal transplant. Moreover, a topical version of tofacitinib is being evaluated for psoriasis and dry eye disease.
In October 2010, Pfizer had presented positive phase II data on tofacitinib for the psoriasis indication. Results showed that tofacitinib met its primary endpoint in the phase II efficacy and safety study. Tofacitinib is currently being evaluated in a phase III program (OPT – Oral Psoriasis Treatment) for the treatment of chronic moderate to severe plaque psoriasis.
We currently have a Neutral recommendation on Pfizer, which is supported by a Zacks #3 Rank (short-term Hold” rating). The successful development and commercialization of tofacitinib would be a major boost for Pfizer.
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