Nov 17, 2021: “The Janssen Pharmaceutical Companies of Johnson & Johnson announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).
At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.
Janssen previously announced week 12 interim analyses from the 48-week, double-blind, placebo-controlled, multicenter Phase 2 dose-ranging GALAXI 1 study.
The primary endpoint of the Phase 2 study is change from baseline in CDAI scores at week 12 in patients treated with TREMFYA compared to placebo.
Overall, all TREMFYA treatment groups during the 48-week treatment period in GALAXI 1 had comparable safety data, consistent with the known safety profile for TREMFYA.
“We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enroll patients in the pivotal Phase 3 GALAXI 2 and 3 studies,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC.
The 48-week GALAXI 1 results mark the first long-term data evaluating TREMFYA in moderately to severely active CD.
Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active CD and moderately to severely active ulcerative colitis are ongoing and enrolling participants. Learn more through the Janssen Global Trial Finder.
About GALAXI 1
GALAXI 1 is a double-blind, placebo-controlled, multicenter Phase 2 dose-ranging study evaluating the efficacy and safety of TREMFYA in participants with moderately to severely active CD with inadequate response/intolerance to conventional therapies (corticosteroid, immunosuppressives) and/or biologics (TNF antagonists, vedolizumab).
Participants 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 the reference arm, ustekinumab, dosed at ~6mg/kg IV at week 0 and then dosed at 90 mg subcutaneously (SC) at week 8; or IV placebo. Comparison with placebo was not conducted beyond week 12.
The primary endpoint of the Phase 2 GALAXI 1 study is change from baseline in CDAI scores at week 12. Additional key outcomes evaluated at week 12 include clinical remission (CDAI<150), clinical response (decrease from baseline in CDAI ≥100 or CDAI<150), Patient Report Outcome (PRO)-2 remission (abdominal pain mean daily score ≤1 and mean daily stool frequency score ≤3), clinical biomarker response (clinical response and ≥50 percent reduction from baseline in C-reactive protein or fecal calprotectin), endoscopic response (≥50 percent improvement from baseline in the SES-CD), and safety in participants treated with TREMFYA compared with placebo. Participants may receive treatment through five years.
About Crohn’s Disease (CD)
CD is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.
CD is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors.
Symptoms of CD can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.
There is currently no cure for CD.
About TREMFYA® (guselkumab)
Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.
IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).
TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA.
It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.”