Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA® (guselkumab) in Adults With Moderately to Severely Active Crohn’s Disease

The Janssen Pharmaceutical Companies of Johnson & Johnson moment blazoned topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical absolution (Crohn’s Disease Activity Index (CDAI)< 150) preliminarily reported at week 12 increased at week 48 among grown-ups with relatively to oppressively active Crohn’s complaint (CD) treated with TREMFYA ® (guselkumab).1 At week 48, 65 percent of cases entering TREMFYA achieved clinical absolution. TREMFYA is under disquisition and not presently approved for the treatment of CD in theU.S. 2

Janssen preliminarily blazoned week 12 interim analyses from the 48-week, double-eyeless, placebo- controlled, multicenter Phase 2 cure- ranging GALAXI 1 study. The primary endpoint of the Phase 2 study is change from birth in CDAI scores at week 12 in cases treated with TREMFYA compared to placebo.3 Overall, all TREMFYA treatment groups during the 48-week treatment period in GALAXI 1 had similar safety data, harmonious with the given safety profile for TREMFYA.

“ We look forward to participating the comprehensive GALAXI 1 48-week results at an forthcoming scientific medical meeting while we continue to progress and enroll cases in the vital 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 assessing TREMFYA in relatively to oppressively active CD.2 Phase 3 clinical trials assessing TREMFYA for the treatment of relatively to oppressively active CD and relatively to oppressively active ulcerative colitis are ongoing and enrolling actors. Learn further through the Janssen Global Trial Finder.

About GALAXI 12
GALAXI 1 is a double-eyeless, placebo- controlled, multicenter Phase 2 cure- ranging study assessing the efficacity and safety of TREMFYA in actors with relatively to oppressively active CD with shy response/ dogmatism to conventional curatives (corticosteroid, immunosuppressives) and/ or biologics (TNF antagonists, vedolizumab).
Actors were randomized inversely into five treatment arms, including treatment with TREMFYA cured at 200, 600 or 1200 mg intravenously (IV) at weeks 0, 4 and 8, independently; or treatment with the reference arm, ustekinumab, cured at
6mg/ kg IV at week 0 and also cured at 90 mg subcutaneously (SC) at week 8; or IV placebo. Comparison with placebo wasn’t conducted beyond week 12.

The primary endpoint of the Phase 2 GALAXI 1 study is change from birth in CDAI scores at week 12. Fresh crucial issues estimated at week 12 include clinical absolution (CDAI< 150), clinical response ( drop from birth in CDAI ≥ 100 or CDAI< 150), Patient Report Outcome (PRO)-2 absolution (abdominal pain mean diurnal score ≤ 1 and mean diurnal coprolite frequence score ≤ 3), clinical biomarker response (clinical response and ≥ 50 percent reduction from birth in C-reactive protein or fecal calprotectin), endoscopic response (≥ 50 percent enhancement from birth in the SES-CD), and safety in actors treated with TREMFYA compared with placebo. Actors may admit treatment through five times.
About Crohn’s Disease (CD)
CD is one of the two main forms of seditious bowel complaint, which affects an estimated three million Americans.4 CD is a habitual seditious condition of the gastrointestinal tract with no given cause, but the complaint is associated with abnormalities of the vulnerable system that could be started by a inheritable predilection, diet or other environmental factors.5 Symptoms of CD can vary, but frequently include abdominal pain and tenderheartedness, frequent diarrhea, rectal bleeding, weight loss, and fever.6 There’s presently no cure for CD.7

About TREMFYA ® (guselkumab) 2
Developed by Janssen, TREMFYA is the first approved completely mortal monoclonal antibody that widely binds to the p19 subunit of IL-23 and inhibits its commerce with the IL-23 receptor. IL-23 is an important motorist of the pathogenesis of seditious conditions similar as moderate to severe shrine psoriasis (PsO) and active psoriatic arthritis (PsA).8 TREMFYA is approved in theU.S., Canada, Japan, and a number of other countries worldwide for the treatment of grown-ups with moderate to severe shrine PsO who may profit from taking injections or capsules (systemic remedy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult cases with active PsA. It’s also approved in the EU for the treatment of moderate to severe shrine PsO in grown-ups who are campaigners for systemic remedy and for the treatment of active PsA in adult cases who have had an shy response or who have been intolerant to a previous complaint- modifying antirheumatic medicine remedy.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide selling rights to TREMFYA ®.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we ’re creating a future where complaint is a thing of the history. We ’re the Pharmaceutical Companies of Johnson & Johnson, working lifelessly to make that future a reality for cases everyplace by fighting sickness with wisdom, perfecting access with imagination, and healing forlornness with heart. We concentrate on areas of drug where we can make the biggest difference Cardiovascular & Metabolism, Immunology, Infectious Conditions & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

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