Sundry Photography/iStock Editorial via Getty Images
Johnson & Johnson's (NYSE:JNJ) Janssen unit on Tuesday said new data from a phase 2 study of its Tremfya therapy for inflammatory bowel diseases (IBD) showed that 47.5%-66.7% of treated patients achieved clinical-biomarker response at week 48.
The new data from the mid-stage GALAXI 1 study follows earlier 48-week results that were announced in February, which showed that Tremfya led to clinical remission in the majority of adults with moderate to severe form of Crohn's disease (CD), a type of IBD.
The new data was presented as oral and poster presentations among 29 abstracts during the Digestive Disease Week (DDW) meeting in San Diego, California.
Janssen's phase 2 GALAXI 1 trial is evaluating the efficacy and safety of Tremfya in adults with moderately to severely active CD. Tremfya is not currently approved in the U.S. to treat CD or ulcerative colitis (UC), another IBD.
The new analyses from the GALAXI 1 trial presented at DDW also showed that 44.3%-46% of patients treated with Tremfya achieved endoscopic response and 39.3%-66.7% patients achieved clinical remission at week 48.
Janssen on Tuesday also announced data presented at DDW from three long-term pooled analyses of adult patients with inflammatory bowel diseases who were treated with its Stelara drug.
The pooled analyses of long-term safety data in CD/UC patients treated with Stelara showed a favorable safety profile consistent with analyses in the overall IBD population and the established safety profile across approved indications.
Tremfya (guselkumab) is designed to block the IL-23 receptor. It is currently approved in the U.S. for adults with plaque psoriasis and active psoriatic arthritis.
Stelara (ustekinumab) is designed to selectively inhibit the IL-12 and IL-23 receptors. It is currently approved in the U.S. for adults with Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.
Tremfya brought in worldwide sales of $590M in Q1 for J&J, while Stelara posted global sales of $2.29B in Q1.