Boehringer Ingelheim Phase II trial now enrolling patients with the kidney disease Lupus Nephritis 

Ingelheim, Germany, May 10, 2017 – Boehringer Ingelheim today announced that a Phase II trial will test the investigational compound BI 655064* for therapy in Lupus Nephritis (LN).

Lupus nephritis is an auto-immune disease that affects the kidneys. It is caused by Systemic Lupus Erythematosus (SLE).  With this disease, patients produce antibodies against their own body tissues[1]. Those patients more severely affected by the disease (so-called LN class III – V patients) are at high risk for irreversible kidney damage and - if the disease is not controlled - kidney failure. 

The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.[2]  Lupus Nephritis occurs  in about 35% in Caucasians up to approximately 50% in Hispanics, Asians and African Americans with SLE. 

Currently, there are no widely approved therapies for lupus nephritis.

The treatment approach investigated in this trial evaluates the efficacy and safety of the antibody BI 655064 that specifically blocks the CD40 receptor.  The CD40 receptor is increased in patients with class III and class IV LN [3]. CD40 receptors are located on various immune and other cells, which are responsible for unwanted immune responses that play a role in causing SLE and LN [4]. Therefore, targeting the CD40 receptor may be a potential treatment option. 

In the trial, eligible patients with Lupus Nephritis will be offered 1 year treatment with BI 655064 in combination with standard of care therapy and responders to therapy at 1 year will be offered to have additional 2 years of treatment. The trial is a worldwide trial recruiting patients in North America, Western- and Eastern Europe, Asia and Australia.

“This trial is of great importance for patients with Lupus Nephritis, since it investigates a new and promising mechanism that has the potential to both improve kidney function and control of their lupus symptoms. It also will allow responding patients to receive medication for an additional two years after the end of the trial.” said Dr David Jayne, Coordinating Principal Investigator of the trial and Director of the Lupus clinic at Addenbrooke's hospital in Cambridge, United Kingdom.

“Boehringer Ingelheim is dedicated to transforming lives of patients with immunological diseases.” said Dr Jan Poth, Therapeutic Area Head Immunology/CNS at Boehringer Ingelheim. “Our innovative trial is designed to include patients with active LN class III and IV and we are glad to be able to investigate a new potential treatment option for patients in urgent need.”

About the trial
This double-blind, randomised, placebo-controlled trial will evaluate the efficacy and safety of three different doses of BI 655064 in comparison to placebo as sub-cutaneous injections over 52 weeks for patients with active LN class III and IV.  All patients will receive background therapy according to treatment guidelines. The primary endpoint is complete renal response at week 52. Other clinical evaluations include assessment of overall SLE symptoms, patient reported outcomes and fatigue.  

For more information including a list of participating sites and countries, please visit clinicaltrials.gov:  https://clinicaltrials.gov/ct2/show/NCT02770170.  Additional sites will be opened in Mexico, Serbia, Malaysia and the Philippines.

Recruitment is still open. If you are interested, please contact Michèle Brun at michele.brun@boehringer-ingelheim.com

About Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN)
SLE can potentially involve every organ, thus its clinical spectrum varies from relatively mild cases towards life-threatening manifestations with severe cytopenia, central nervous system disease and renal impairment. Lupus nephritis is one of the most serious complications of systemic lupus erythematosus since it is the major predictor of a poor prognosis. Lupus nephritis (LN) is characterized by persistent proteinuria and loss of renal function.  Persistent active and long-lasting lupus nephritis causes end-stage renal disease and death.  The incidence of LN in SLE patients varies with ethnic background ranging from about 35% in Caucasians to about 46% in Hispanics or Asians and to about 50% in African Americans.  African Americans also show the worst clinical outcome and the lowest response to current therapy.  

About BI 655064*
BI 655064* is a humanized mouse anti-human monoclonal antibody which is purely antagonistic against CD40. BI 655064 binds human CD40 on B cells present in whole blood [5]. 

BI 655064 has been well tolerated in toxicology studies up to 26 weeks at doses higher than those deemed clinically relevant. 

In addition, BI 655064 has been evaluated in healthy volunteers [6], patients with rheumatoid arthritis [7] and patients with immune thrombocytopenia, supporting further clinical development.

BI 655064 has been discovered and developed at Boehringer Ingelheim’s Immunology research laboratories and is part of a global collaboration of AbbVie and Boehringer Ingelheim, announced in March 2016. AbbVie gained rights to BI 655064, currently in Phase 2 development. Boehringer Ingelheim will retain responsibility for further development of BI 655064, and AbbVie may elect to advance the program after completion of certain undisclosed clinical achievements. 

*BI 655064 is an investigational drug and is not approved by any regulatory agency for commercial use.

About Boehringer Ingelheim
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does. 

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
 

* BI 655064 is an ivestigational drug and is not approved by any regulatory agency for commercial use.