LEL Lilly(Eli)

 
TIDMLEL 
 
Date: March 28, 2012 
 
For Release: Immediately 
 
Refer to: Sonja Popp-Stahly, +1 317-655-2993, spopp-stahly@lilly.com 
 
   Lilly's Anti-IL-17 Monoclonal Antibody, Ixekizumab, Met Primary Endpoint 
 
          in Phase II Study in Patients With Chronic Plaque Psoriasis 
 
         - Results published in New England Journal of Medicine showed 
 
               significantly more patients achieved improvements 
 
            in skin disease severity scores compared with placebo - 
 
INDIANAPOLIS - New Phase II data, published today in the New England Journal of 
Medicine, showed that Eli Lilly and Company's (NYSE: LLY) ixekizumab 
(pronounced ix" e kiz' ue mab, previously known as LY2439821), an anti-IL-17 
monoclonal antibody, met its primary endpoint in patients with 
moderate-to-severe plaque psoriasis, with significantly more patients achieving 
at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) 
scores from baseline (PASI 75) compared with placebo at week 12. 
 
PASI score represents a combined assessment of overall skin lesions ranging 
from 0 for no psoriasis to 72 for the worst possible psoriasis in a patient and 
is a standard measure of skin disease severity in clinical trials in psoriasis. 
A PASI 75 response in a patient represents a 75 percent reduction of PASI 
scores from baseline. 
 
In the 142-subject study, significantly more patients achieved a PASI 75 
response in the 150 mg (82 percent), 75 mg (83 percent) and 25 mg (77 percent) 
ixekizumab groups compared with placebo (8 percent, p<0.001) at week 12. The 10 
mg dose (29 percent) did not separate from placebo at week 12. 
 
Secondary endpoints included an evaluation of the percentage of patients 
achieving at least 90 percent and 100 percent improvement in PASI (PASI 90 or 
PASI 100) at week 12. In patients treated with ixekizumab, the percentages of 
patients achieving a PASI 90 response were 71 percent (150 mg), 59 percent (75 
mg) and 50 percent (25 mg), which were significantly higher than with placebo 
(0 percent). PASI 100 responses were significantly better at the 150 mg dose 
(39 percent) and 75 mg dose (38 percent) when compared with placebo (0 
percent). PASI 100 responses at the 25 mg (17 percent) and 10 mg doses (0 
percent) were not significantly greater than placebo, nor was the PASI 90 
response at the 10 mg dose (18 percent). 
 
PASI 75 response was significantly better than placebo as early as week 2 at 
the highest dose, and significant differences from placebo in PASI scores were 
seen as early as week 1 at the two highest doses and by week 4 for the 
remaining two doses. Differences from placebo were sustained to week 20 in both 
PASI 75 responses and PASI scores. 
 
Skin disease severity also was evaluated by static Physician Global Assessments 
(sPGA), with patients having a score of 3-5 (moderate to severe disease) at 
baseline. Significantly more patients treated with ixekizumab achieved an sPGA 
score of 0 (clear of disease) or 1 (minimal disease), when compared with 
placebo at week 12. The percentage of patients achieving an sPGA 0 or 1 score 
were 71 percent (150 mg), 72 percent (75 mg), 70 percent (25 mg) and 25 percent 
(10 mg) compared with 8 percent (placebo), with the highest three doses being 
significantly higher than placebo. The percentage of patients achieving an sPGA 
score of 0 at week 12 were 46 percent (150 mg), 38 percent (75 mg), 20 percent 
(25 mg), 7 percent (10 mg) and 0 percent (placebo), again with the highest 
three ixekizumab doses being significantly higher than placebo. 
 
Approximately 40 percent of patients in the two highest dose groups had 
complete clearance of psoriasis plaques on the skin, as reflected by a 
reduction in the PASI score by 100 percent or an sPGA score of 0 at 12 weeks. 
 
In addition, significant reductions in mean Nail Psoriasis Severity Index 
(NAPSI) and Psoriasis Scalp Severity Index (PSSI), which evaluate disease in 
the difficult-to-treat areas of nails and scalp, respectively, were seen at the 
two highest ixekizumab doses compared with placebo at week 12 (NAPSI: 150 mg 
[-49.3 percent], 75 mg [-57.1 percent], placebo [+6.8 percent]; PSSI: 150 mg 
[-84.8 percent], 75 mg [-94.8 percent], placebo [-30.5 percent]). 
 
The frequency of adverse events in both the combined ixekizumab groups and in 
the placebo group was 63 percent, with the most common adverse events observed 
being nasopharyngitis (inflammation of the nasal passages and of the upper part 
of the pharynx), upper respiratory infection, injection site reactions and 
headache. There were no serious adverse events reported. Infections occurred in 
33 percent (38 patients) of subjects receiving ixekizumab and 26 percent (seven 
patients) receiving placebo. No dose-related trends in infections or other 
adverse events were observed. Four patients (one in the placebo group, two in 
the 10 mg group and one in 25 mg group) discontinued the study due to adverse 
events. 
 
"These data suggest ixekizumab may be an effective treatment for patients with 
chronic moderate-to-severe plaque psoriasis and could represent a new treatment 
approach for patients with this condition," said Craig Leonardi, M.D., clinical 
professor of dermatology at the Saint Louis University School of Medicine, and 
lead author of the manuscript. "Further studies are needed, but we are 
encouraged by the results showing improvements in skin clearance early in 
treatment." 
 
Psoriasis is the most prevalent chronic, autoimmune disease of the skin in the 
United States, affecting about 7.5 million people. It occurs when the immune 
system sends out faulty signals that speed up the growth cycle of skin cells. 
Approximately 17 percent of psoriasis patients have moderate-to-severe plaque 
psoriasis. 
 
"While there are a number of commonly used treatments for autoimmune diseases, 
new and alternative treatment options are needed for those impacted by these 
potentially debilitating conditions, including psoriasis," said Eiry Roberts, 
M.D., vice president of autoimmune product development at Lilly. "We are 
committed to developing new autoimmune therapies such as ixekizumab, which was 
discovered in our own research labs and is now being studied in Phase III for 
psoriasis." 
 
About the Study 
 
A total of 142 patients with chronic moderate-to-severe plaque psoriasis 
participated in the randomized, double-blind, placebo-controlled, 
parallel-group, dose-ranging study. Patients were randomized to receive 
subcutaneous injections of placebo or 10 mg, 25 mg, 75 mg or 150 mg of 
ixekizumab at weeks 0, 2, 4, 8, 12 and 16. Data were collected at baseline, and 
weeks 1, 2, 4, 6, 8, 12, 16 and 20. 
 
To view the published manuscript, please visit www.nejm.org. 
 
About Ixekizumab 
 
Ixekizumab is a humanized monoclonal antibody that binds to and neutralizes 
actions of the pro-inflammatory cytokine, interleukin-17A (IL-17A, also called 
IL-17), and is administered via subcutaneous injection. Ixekizumab is currently 
in Phase III testing for psoriasis and is being evaluated as a potential 
treatment for psoriatic arthritis, rheumatoid arthritis and ankylosing 
spondylitis. 
 
About Psoriasis 
 
The most common form of psoriasis, plaque psoriasis, appears as raised, red 
patches covered with a silvery white buildup of dead skin cells. Psoriasis can 
occur on any part of the body and is associated with other serious health 
conditions, such as diabetes and heart disease., 
 
Psoriasis involving scalp, nails and palms and soles is hard to treat. Despite 
the availability of biologics and topical treatments, patients are still in 
need of new and alternative treatment options to treat the disease. 
 
About Eli Lilly and Company 
 
Lilly, a leading innovation-driven corporation, is developing a growing 
portfolio of pharmaceutical products by applying the latest research from its 
own worldwide laboratories and from collaborations with eminent scientific 
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - 
through medicines and information - for some of the world's most urgent medical 
needs. Additional information about Lilly is available at www.lilly.com. 
 
This press release contains certain forward-looking statements about ixekizumab 
as a potential treatment for patients with chronic plaque psoriasis and 
reflects Lilly's current beliefs. However, as with any pharmaceutical product, 
there are substantial risks and uncertainties in the process of development and 
commercialization. There is no guarantee that future study results and patient 
experience will be consistent with study findings to date or that the product 
will be commercially successful. For further discussion of these and other 
risks and uncertainties, see Lilly's filings with the United States Securities 
and Exchange Commission. Lilly undertakes no duty to update forward-looking 
statements. 
 
                                     # # # 
 
P-LLY 
 
 
 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
www.lilly.com 
 
 
 
National Psoriasis Foundation, "About Psoriasis," 
http://psoriasis.org/about-psoriasis. Accessed March 23, 2012. 
 
Rapp SR, Feldman SR, Exum ML, Fleischer AB, Reboussin DM. Psoriasis causes as 
much disability as other major medical diseases. J Am Acad Dermatol 1999;41: 
401-7. 
 
Kurd SK, et al. The Risk of Depression, Anxiety, and Suicidality in Patients 
With Psoriasis. Arch Dermatol. 2010;146(8):891-895. 
 
National Psoriasis Foundation, "Psoriasis on Specific Locations," 
http://www.psoriasis.org/about-psoriasis/specific-locations. Accessed March 23, 2012. 
 
 
 
 
END 
 

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