TREMFYA? (guselkumab) Induces Clinical and Endoscopic Improvements in Patients with Moderately to Severely Active Crohn's Disease based on Interim Results from Phase 2 Study

GALAXI 1 is a double-blind, placebo-controlled, multicenter Phase 2 dose-ranging study evaluating the efficacy and safety of TREMFYA??(guselkumab) in patients with moderately to severely active Crohn's disease with inadequate response/intolerance to conventional therapies (corticosteroid, immunosuppressive) and/or biologics (TNF antagonist, vedolizumab). Patients will receive treatment through up to 3 years. Interim analyses at week 12 evaluated the key outcomes of change in CDAI score from baseline, clinical remission (CDAI<150), clinical response (decrease from baseline in CDAI =100 or CDAI<150), PRO-2 remission (abdominal pain mean daily score =1 and mean daily stool frequency score =3), clinical biomarker response (clinical response and =50% reduction from baseline in C-reactive protein or fecal calprotectin), endoscopic response (=50% improvement from baseline in the SES-CD), and safety in patients treated with TREMFYA compared with placebo. The efficacy and safety of the reference arm (ustekinumab) compared with placebo was also evaluated?and demonstrated. About Crohn's disease (CD)
CD is one of the two main forms of inflammatory bowel disease, which affects an estimated 3 million Americans.4?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.5?Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever.5,6?There is currently no cure for CD.6 About TREMFYA??(guselkumab)
Developed by Janssen, TREMFYA??is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor.2?TREMFYA??is approved in the U.S.,?Canada, the European Union,?Japan?and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet [UV] light).2?It is approved in the U.S.,?Canada,?Japan,?Brazil?and?Ecuador?for the treatment of adult patients with active psoriatic arthritis. IL-23 is an important driver of the pathogenesis of immune-mediated inflammatory diseases such as psoriasis.7 The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA?. Important Safety Information
What is the most important information I should know about TREMFYA??
TREMFYA??is a prescription medicine that may cause serious side effects, including:
- Serious Allergic Reactions.?Stop using TREMFYA??and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded (low blood pressure)
- swelling of your face, eyelids, lips, mouth, tongue or throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives, itching
- Infections.?TREMFYA??may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA??and may treat you for TB before you begin treatment with TREMFYA??if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA?.
Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than normal
- have any of the conditions or symptoms listed in the section?"What is the most important information I should know about TREMFYA??"
- have an infection that does not go away or that keeps coming back.
- have TB or have been in close contact with someone with TB.
- have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA?.
- are pregnant or plan to become pregnant. It is not known if TREMFYA??can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if TREMFYA??passes into your breast milk.
TREMFYA??may cause serious side effects. See "What is the most important information I should know about TREMFYA??" The most common side effects of TREMFYA??include:?upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA?. Call your doctor for medical advice about side effects. Use TREMFYA??exactly as your healthcare provider tells you to use it. Please read the full?Prescribing Information, including?Medication Guide?for TREMFYA?, and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit?www.fda.gov/medwatch, or call 1-800-FDA-1088. About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at?www.janssen.com. Follow us at?www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is a part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the Phase 2 Week 12 interim study of TREMFYA??(guselkumab) in Crohn's disease. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of?Janssen Research & Development, LLC,?and any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.?Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended?December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at?www.sec.gov,?www.jnj.com?or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. iDr?William J. Sandborn?is?a paid consultant for Janssen. He has not been compensated for any media work. References
- Sandborn, W,?et al.?The Efficacy and Safety of Guselkumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease: Week 12 Interim Analyses from the Phase 2 GALAXI 1 Study (Abstract OP089). Presented at the UEGW Virtual 2020 Congress October 11?13.
- Food and Drug Administration. TREMFYA Prescribing Information. 2017. Available at:?https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761061s000lbl.pdf. Accessed?September 14, 2020.
- Clinicaltrials.gov. A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (GALAXI). Identifier:?NCT03466411. Available at:?https://clinicaltrials.gov/ct2/show/record/NCT03466411. Accessed?August 2020.
- Crohn's & Colitis Foundation. Overview of Crohn's Disease. Available at:?https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed?September 14, 2020.
- Crohn's and Colitis Foundation. Causes of Crohn's disease. Available at:?https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed?October 2020.
- Mayo Clinic. Crohn's disease. Available at?https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed?October 2020.
- Benson JM,?et al. Discovery and Mechanism of Ustekinumab.?MAbs?2011 3:535.
Bridget Kimmel?
Mobile: (215)?688-6033 Investor Contacts:
Chris DelOrefice
Office: (732) 524-2955 Jennifer McIntyre
Office: (732) 524-3922 SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson
