Date: 14-Oct-2020

Janssen Announces Positive Interim Data From Phase 2 GALAXI 1 Study Of Tremfya To Treat Crohns Disease

The Janssen Pharmaceutical Companies of Johnson & Johnson announced phase 2 interim data from the GALAXI 1 study, which showed Tremfya (guselkumab) demonstrated results at week 12 in adult patients with moderately to severely active Crohn's disease (CD) with inadequate response or intolerance to conventional therapies and/or biologics.

At 12 weeks, Tremfya induced significantly greater improvements compared to placebo across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is not currently approved for the treatment of CD in the US.

These new data are being presented as an oral presentation (Abstract OP089) at the 28th United European Gastroenterology (UEG) Week, which is conducting its annual congress virtually.

“While there have been substantial treatment breakthroughs in Crohn's disease, there are still patients who are not gaining benefit from any of the currently approved mechanisms of action for their symptoms,” said lead study investigator William J. Sandborni, M.D., chief of Gastroenterology, Professor of Medicine, University of California, San Diego, who is delivering the oral presentation virtually at UEG Week. “I am encouraged by these early data, which show that Tremfya across three different dosing groups induced a significant response in key clinical and endoscopic outcome measures in Crohn's disease.”

GALAXI 1 evaluated the efficacy and safety of Tremfya compared with placebo in CD. The interim analyses reported results through week 12 from the first 250 patients enrolled. Approximately 50 percent of patients had previously failed biologic therapy; and baseline disease characteristics were consistent with moderately to severely active CD (Crohn's Disease Activity Index [CDAI], mean 306.6; Simple Endoscopic Score for Crohn's Disease [SES-CD], median 11.0). Patients were randomized equally into five treatment arms, including treatment with TREMFYA dosed at 200, 600 or 1200 mg intravenously (IV) at weeks 0, 4 and 8, respectively; or treatment with ustekinumab dosed at ~6mg/kg IV at week 0 and then dosed at 90 mg subcutaneously (SC) at week 8; or placebo.

At week 12, there were significantly greater reductions from baseline in the CDAI observed in each Tremfya group (200, 600 or 1200 mg IV doses) compared with placebo (Least Squares [LS] means: -154.1, -144.3, -149.5 versus -36.0, respectively; all p<0.001). A significantly higher proportion of patients assigned to each Tremfya dose achieved clinical remission compared with placebo (CDAI<150): 54.0 percent, 56.0 percent, 50.0 percent, respectively, versus 15.7 percent (p<0.001). Among conventional therapy failures, 61.6 percent in the Tremfya-combined group versus 18.5 percent treated with placebo achieved clinical remission at week 12. Among patients who had previously failed biologic therapy, 45.5 percent in the Tremfya-combined group compared with 12.5 percent in the placebo group achieved clinical remission at week 12