Business Wire

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

Share

The Janssen Pharmaceutical Companies of Johnson & Johnson today 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.1 At 12 weeks, guselkumab induced significantly greater improvements compared to placebo across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications.1 Guselkumab is not currently approved for the treatment of CD in the European Union (EU).2

These new data are being presented today as an oral presentation (Abstract OP089) at the 28th United European Gastroenterology (UEG) Week, which is conducting its annual congress virtually.1

“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. Sandborn,* 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 guselkumab 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 guselkumab 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 randomised equally into five treatment arms, including treatment with guselkumab dosed at 200, 600 or 1200 mg intravenously (IV) at weeks 0, 4 and 8, respectively; or treatment with ustekinumab dosed at ~6 mg/kg IV at week 0 and then dosed at 90 mg subcutaneously at week 8; or placebo.1

At week 12, there were significantly greater reductions from baseline in the CDAI observed in each guselkumab group (200, 600 or 1200 mg IV doses) compared with placebo (Least Squares [LS] means: -154.1, -144.3 and -149.5 versus -36.0, respectively; all p<0.001). A significantly higher proportion of patients assigned to each guselkumab 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 guselkumab-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 guselkumab-combined group compared with 12.5 percent in the placebo group achieved clinical remission at week 12.1

Furthermore, at week 12, a significantly higher proportion of patients treated with guselkumab achieved clinical response (p<0.001), patient reported outcome (PRO)-2 remission (p<0.001), clinical-biomarker response (p<0.001), and endoscopic response (p<0.001) compared with patients treated with placebo. Endoscopic healing is an important outcome for long-term disease control; 37.3 percent of patients in the guselkumab-combined group compared with 11.8 percent in the placebo group achieved endoscopic response after only 12 weeks of induction treatment (p<0.001).1

“For patients living with moderately to severely active Crohn’s disease, including those who have not had an adequate response or have intolerance to other therapies, these results show that guselkumab may play an important role as a new treatment option pending results from the ongoing registration trials,” said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. “Although more research is needed, we are encouraged by the data and the potential role for selective IL-23 inhibition in helping patients manage their Crohn’s disease symptoms and treating the underlying disease process.”

Guselkumab demonstrated a safety profile consistent with that established from prior clinical trials across approved indications. Observed adverse events (AEs) were generally similar amongst treatment groups and placebo through week 12. In the guselkumab 200, 600, 1200 mg IV and placebo treatment groups, serious AEs occurred in 4 percent, 4 percent, 2 percent and 4 percent, and serious infections occurred in 2 percent, 0 percent, 0 percent and 0 percent of patients, respectively. There were no reported deaths in guselkumab-treated patients, and no guselkumab-treated patient had active tuberculosis, serious hypersensitivity reactions or malignancies.1 Very common (>10%) and common AEs (>1%) in controlled periods of clinical studies with guselkumab were upper respiratory infections, gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia and injection site reactions. Uncommon AEs observed were hypersensitivity, anaphylaxis and rash.2

About the GALAXI 1 trial1,3

GALAXI 1 is a double-blind, placebo-controlled, multicentre Phase 2 dose-ranging study evaluating the efficacy and safety of 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 guselkumab 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 up to 2 million people across Europe.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 diarrhoea, rectal bleeding, weight loss and fever.5,6 There is currently no cure for CD.7

About TREMFYA® (guselkumab)

Developed by Janssen, guselkumab 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 Guselkumab is approved in the EU, US, Canada, 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 US, Canada, Japan, Brazil and Ecuador for the treatment of adult patients with active psoriatic arthritis.2 IL-23 is an important driver of the pathogenesis of immune-mediated inflammatory diseases such as psoriasis.8 Guselkumab is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4.2

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.

Important Safety Information2

Very common (>10%) and common AEs (>1%) in controlled periods of clinical studies with guselkumab were upper respiratory infections, gastroenteritis, herpes simplex infections, tinea infections, headache, diarrhoea, urticaria, arthralgia and injection site reactions. Uncommon AEs observed were hypersensitivity, anaphylaxis and rash. Most were considered to be mild and did not necessitate discontinuation of study treatment.

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya#product-information-section.

AEs should be reported. This medicinal product is subject to additional monitoring and it is, therefore, important to report any suspected AEs related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. AEs should also be reported to Janssen-Cilag Ltd on 01494 567447.

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/emea.

Follow us at www.twitter.com/JanssenEMEA.

Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA® in the EU, and Janssen Research & Development, LLC, are 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 materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, 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 behaviour 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.

*Dr William J. Sandborn is a paid consultant for Janssen. He has not been compensated for any media work.

References

  1. 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 UEG Week Virtual 2020 Congress October 11–13.
  2. European Medicines Agency. TREMFYA Summary of Product Characteristics. 2019. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed October 2020.
  3. 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 October 2020.
  4. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. TheLancet 2017;390:2769-2778.
  5. Crohn’s and Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed October 2020.
  6. Crohn’s and Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed October 2020.
  7. Mayo Clinic. Crohn’s disease. Available at https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Accessed October 2020.
  8. Benson JM, et al. Discovery and Mechanism of Ustekinumab. MAbs 2011;3:535.

Contact information

Media Contact:
Emily Bone
Mobile: +44 787 639 4360
Email: ebone1@its.jnj.com

Investor Relations:
Christopher DelOrefice
Office: +1 (732) 524 2955

Jennifer McIntyre
Office: +1 (732) 524 3922

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PMI Announces Medicago to Supply Up to 76 Million Doses of Its Plant-Derived COVID-19 Vaccine Candidate23.10.2020 20:00:00 CESTPress release

Since 2008, Philip Morris Investments B.V. (PMIBV), a subsidiary of Philip Morris International (PMI) (NYSE: PM), has been a shareholder of Medicago (in which it currently holds an approximately one-third equity stake) and has supported Medicago’s innovative plant-derived research and development focused on vaccines. The investment is consistent with PMI’s own efforts to leverage science and innovation. Japan-based Mitsubishi Tanabe Pharma Corporation (MTPC) is the majority shareholder and PMIBV’s partner in Medicago. Among other things, PMIBV and MTPC will contribute additional funding to support Medicago’s efforts to develop a COVID-19 vaccine candidate. Medicago, a biopharmaceutical company headquartered in Quebec City, announced that it reached an agreement with Public Services and Procurement Canada (PSPC) to supply up to 76 million doses of its vaccine candidate for COVID-19, subject to Health Canada approval. Innovation, Science & Economic Development (ISED), another department

Fujikura Enters 5G mmWave Infrastructure Market With the Introduction of Industry’s Highest Performance, and Low Power Consumption Phased Array Antenna Module (PAAM)23.10.2020 10:00:00 CESTPress release

Fujikura Ltd. (TOKYO:5803) (President & CEO: Masahiko Ito) today announced the introduction of industry’s most advanced and highly integrated Phased Array Antenna Module (PAAM) for 5G mmWave operating in 3GPP bands n257 (28 GHz), n258 (26 GHz) and n261 (27 GHz). The Fujikura PAAM is the industry’s highest performance PAAM targeting indoor and outdoor applications such as 5G mmWave Fixed Wireless Access (FWA), 5G mmWave Mobile Wireless Access (MWA), 5G mmWave wireless backhaul, and other emerging applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201023005099/en/ Fig.1 Block diagram of Fujikura PAAM. (Graphic: Business Wire) Key Differentiating Features of the Fujikura PAAM The Fujikura PAAM is a high performance phased array antenna module with a novel integrated antenna, and supports concurrent dual polarized beams in both transmission and reception (Fig.1). The PAAM integrates best-in-class mmWave-ICs developed i

VAAST Bikes Now Available in Europe23.10.2020 09:02:00 CESTPress release

VAAST Bikes, a forward-thinking bicycle manufacturer known for its innovative Allite® Super Magnesium™ frames, has signed an agreement with German cycling-specialist retailer giant Internetstores (Fahrrad.de/Brügelmann.de/Bikester). Two of VAAST’s key bicycle models – including the gravel-ready all-road A/1 bike, and the urban U/1 – are now stocked at Internetstores’ eCommerce sites. Both VAAST models will be available to order online for delivery in fourteen locations across Europe via Fahrrad.de/Brügelmann.de in Germany and the partner site Bikester in 13 countries, including the UK, France, the Netherlands, Belgium, Switzerland, Austria, Poland, Denmark, Italy, Sweden, Norway, Finland and Spain. Customers in Germany can benefit from personal service in Fahrrad.de’s five stores and 190 local service partners, while eCommerce customers Europe-wide will be able to receive their new VAAST bicycle within just days of ordering online. VAAST’s unique position as the only bicycle manufactur

Mitsubishi Chemical Holdings Corporation: Notice Regarding Change in Representative Corporate Executive Officers23.10.2020 08:40:00 CESTPress release

Mitsubishi Chemical Holdings Corporation (“MCHC”) (TOKYO: 4188) announced that, at the meeting of its Board of Directors held today, it resolved change of representative corporate executive officers as outlined below. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022006285/en/ Jean-Marc Gilson (Photo: Business Wire) 1. Change in Representative Corporate Executive Officers (Appointed) Name: Jean-Marc Gilson Title: Representative Corporate Executive Officer President and Chief Executive Officer (Retiring) Name: Hitoshi Ochi Title: Representative Corporate Executive Officer President and Chief Executive Officer 2. Biographical Sketch of New Representative Corporate Executive Officer Refer to the appendix 3. Scheduled Date of Appointment April 1, 2021 4. Reason for the Change MCHC converted to a company with a nominating committee, etc. in June 2015. Since then, the Nominating Committee has carried out preparations to proper

MYAH Wins Prestigious Silmo D’Or Award23.10.2020 07:00:00 CESTPress release

Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award in the Material/Equipment category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022005242/en/ Topcon Healthcare announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award. (Photo: Business Wire) The Silmo D’Or Awards are presented each year to recognize creativity in optical product design, innovation and technology. This year marked the 27th annual awards ceremony, which was held virtually and live streamed online on Saturday, October 3rd. The award committee was proud to recognize forward-thinking companies who have continued to launch products and propel the industry forward despite the global pandemic. MYAH came out on top in the Material/Equipment category and

ABB: Q3 2020 Results23.10.2020 06:46:00 CESTPress release

“Third quarter revenues in all business areas were still dampened due to the impact of COVID-19, although a strong recovery in China and ongoing cost mitigation efforts supported a strong underlying performance. On the upside, the integration of GEIS and turnaround of Installation Products in Electrification is starting to bear fruit and Motion is performing robustly. Robotics and Industrial Automation, on the other hand, are taking more time to recover,” said Björn Rosengren, CEO of ABB. “We are pushing ahead with the decentralization of the group and the ongoing review of our portfolio, while carrying out our share buyback program as planned. We look forward to presenting further details on our strategic progress at our Capital Markets Day on November 19.” KEY FIGURES CHANGE CHANGE ($ millions, unless otherwise indicated) Q3 2020 Q3 2019 US$ Comparable 9M 2020 9M 2019 US$ Comparable Orders 6,109 6,688 -9% -8% 19,509 21,702 -10% -7% Revenues 6,582 6,892 -4% -4% 18,952 20,910 -9% -7% I

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom