Welcome!

News Feed Item

Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies

INDIANAPOLIS, Aug. 21, 2014 /PRNewswire/ --

  • Ixekizumab met all primary and key secondary objectives across three pivotal studies of 3,866 patients, the largest Phase 3 moderate-to-severe plaque psoriasis program to date
  • Ixekizumab was superior to etanercept on all measures of skin clearance in both active comparator studies
  • Lilly plans regulatory submissions for ixekizumab in 1st half of 2015

Eli Lilly and Company's (NYSE: LLY) investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis.

"These data are important for people suffering from moderate-to-severe plaque psoriasis, as up to 41 percent of those treated with ixekizumab were able to achieve clear skin at week 12, with just one injection per dose. These results give us confidence that if approved, ixekizumab could make complete resolution of psoriasis possible for significantly more people," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines. 

Study design
In the three UNCOVER studies, patients were assigned to receive either placebo or ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160 mg starting dose. In the two active comparator studies (UNCOVER-2 and 3), patients could be assigned to receive etanercept 50 mg twice weekly for 12 weeks. In UNCOVER-1, responders to treatment were assigned to continue treatment on either placebo or ixekizumab (80 mg every 4 or 12 weeks) for up to 60 weeks.

Results
Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. Skin clearance was measured by standard primary endpoints for psoriasis studies: the Psoriasis Area and Severity Index (PASI) and the Static Physician Global Assessment (sPGA).

For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in PASI score (PASI 75) at 12 weeks. Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12.  For comparison, between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100.

Statistically significant improvements in skin clearance measures for patients treated with ixekizumab were observed as early as the first week when compared to either placebo or etanercept, and continued through week 12. In the UNCOVER-1 study, high levels of response were maintained through 60 weeks of treatment.

Adverse events were comparable for patients receiving ixekizumab in the 12-week, randomized control portion across all three studies. The overall rates and severities of adverse events observed were comparable to those for etanercept in the two active comparator trials. The most frequently reported events (more than five percent across all three studies) were nasopharyngitis and injection site reaction.  Most injection site reactions were mild, and most patients who experienced an injection site reaction continued treatment with ixekizumab.

"Moderate-to-severe plaque psoriasis can have a devastating life impact for patients," Ricks said. "Clear skin is their goal, but many patients are not able to achieve complete resolution using currently-available treatments."

Lilly plans to submit full data from the UNCOVER studies for disclosure at scientific meetings and in peer-reviewed journals in 2015. The company intends to submit ixekizumab to regulatory authorities in the first half of 2015.

"Ixekizumab was discovered and engineered to achieve high affinity and specificity to the IL-17A cytokine by Lilly Research Laboratories scientists, and is the most advanced asset in Lilly's pipeline of biotechnology-based medicines for the treatment of autoimmune diseases," said Tom Bumol, Ph.D., senior vice president of biotech discovery research, Lilly Research Laboratories, and president, Applied Molecular Evolution. "These data appear to confirm our hypothesis -- that IL-17A is a major driver of excess keratinocyte (skin cell) proliferation and activation in psoriasis. We're encouraged that this discovery by Lilly scientists could provide a new treatment option for patients with moderate-to-severe plaque psoriasis."

About the UNCOVER studies
Patients enrolled in the UNCOVER studies had a confirmed diagnosis of chronic plaque psoriasis for at least six months prior to randomization. Additionally, at screening and at randomization they demonstrated at least 10 percent Body Surface Area (BSA) of psoriasis, an sPGA score of at least 3 and PASI score of at least 12. UNCOVER-1 compared the safety and efficacy of different dosing regimens of ixekizumab to placebo after 12 weeks and 60 weeks of treatment. UNCOVER-2 and 3 evaluated different dosing regimens of ixekizumab compared to either placebo or etanercept for 12 weeks.

About ixekizumab
Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A). In psoriasis, IL-17A plays a major role in driving excess keratinocyte (skin cell) proliferation and activation. Ixekizumab does not bind to cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered via subcutaneous injection (under the skin). Ixekizumab is also in clinical development for the treatment of psoriatic arthritis.

About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, noncontagious autoinflammatory disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.[i] It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.[ii] Psoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes and heart disease.[iii],[iv]

The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells. Approximately 17 percent of psoriasis patients have moderate-to-severe plaque psoriasis.[v]

About Eli Lilly and Company  
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

P-LLY

This press release contains forward-looking statements about ixekizumab as a potential treatment for moderate-to-severe plaque psoriasis and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization.  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.

[i] National Psoriasis Foundation®, File, Communications, Psoriasis, http://www.psoriasis.org/file/communications---all-documents/MediaKit.pdf  (Accessed August 20, 2014).

[ii] Ibid.

[iii] 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.

[iv] Kurd SK, et al. The Risk of Depression, Anxiety, and Suicidality in Patients With Psoriasis. Arch Dermatol. 2010;146(8):891-895.

[v] National Psoriasis Foundation®, "Psoriasis Severity," http://psoriasis.org/about-psoriasis/treatments/severity     (Accessed July 15, 2014.)

Contact: J. Scott MacGregor, [email protected], +1-317-440-4699

Eli Lilly and Company logo

Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO

SOURCE Eli Lilly and Company

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
For enterprises to maintain business competitiveness in the digital economy, IT modernization is required. And cloud, with its on-demand, elastic and scalable principles has resoundingly been identified as the infrastructure model capable of supporting fast-changing business requirements that enterprises are challenged with, as a result of our increasingly connected world. In fact, Gartner states that by 2022, 28% of enterprise IT spending will have shifted to cloud. But enterprises still must d...
Cloud-Native thinking and Serverless Computing are now the norm in financial services, manufacturing, telco, healthcare, transportation, energy, media, entertainment, retail and other consumer industries, as well as the public sector. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that pro...
The level of trust we have with individuals, businesses, and technology affects our lives daily. This is important to remember when discussing new technologies. For example, our level of trust is a critical factor when evaluating a new technology as a potential solution for providing business value. Given the importance of trust, imagine one's reaction upon hearing that blockchain is a "trustless trust" system. On the surface, that does sound like an oxymoron. This paper discusses how "trustless...
Public clouds dominate IT conversations but the next phase of cloud evolutions are "multi" hybrid cloud environments. The winners in the cloud services industry will be those organizations that understand how to leverage these technologies as complete service solutions for specific customer verticals. In turn, both business and IT actors throughout the enterprise will need to increase their engagement with multi-cloud deployments today while planning a technology strategy that will constitute a ...
Data center, on-premise, public-cloud, private-cloud, multi-cloud, hybrid-cloud, IoT, AI, edge, SaaS, PaaS... it's an availability, security, performance and integration nightmare even for the best of the best IT experts. Organizations realize the tremendous benefits of everything the digital transformation has to offer. Cloud adoption rates are increasing significantly, and IT budgets are morphing to follow suit. But distributing applications and infrastructure around increases risk, introdu...
Moving to Azure is the path to digital transformation, but not every journey is effective. Organizations that start with a cohesive, well-planned migration strategy can avoid common mistakes and stay a step ahead of the competition. Learn from Atmosera CEO, Jon Thomsen about the opportunities and challenges found in three pivotal phases of the journey to the cloud: Evaluation and Architecting, Migration and Management, and Optimization & Innovation. In each phase, there are distinct insights tha...
Most modern computer languages embed a lot of metadata in their application. We show how this goldmine of data from a runtime environment like production or staging can be used to increase profits. Adi conceptualized the Crosscode platform after spending over 25 years working for large enterprise companies like HP, Cisco, IBM, UHG and personally experiencing the challenges that prevent companies from quickly making changes to their technology, due to the complexity of their enterprise. An accomp...
At CloudEXPO Silicon Valley, June 24-26, 2019, Digital Transformation (DX) is a major focus with expanded DevOpsSUMMIT and FinTechEXPO programs within the DXWorldEXPO agenda. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throug...
Every organization is facing their own Digital Transformation as they attempt to stay ahead of the competition, or worse, just keep up. Each new opportunity, whether embracing machine learning, IoT, or a cloud migration, seems to bring new development, deployment, and management models. The results are more diverse and federated computing models than any time in our history.
Andrew Keys is co-founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settlement products to hedge funds and investment banks. After, he co-founded a revenue cycle management company where he learned about Bitcoin and eventually Ethereum.
Bill Schmarzo, author of "Big Data: Understanding How Data Powers Big Business" and "Big Data MBA: Driving Business Strategies with Data Science" is responsible for guiding the technology strategy within Hitachi Vantara for IoT and Analytics. Bill brings a balanced business-technology approach that focuses on business outcomes to drive data, analytics and technology decisions that underpin an organization's digital transformation strategy. Bill has a very impressive background which includes ...
Most organizations are awash today in data and IT systems, yet they're still struggling mightily to use these invaluable assets to meet the rising demand for new digital solutions and customer experiences that drive innovation and growth. What's lacking are potent and effective ways to rapidly combine together on-premises IT and the numerous commercial clouds that the average organization has in place today into effective new business solutions. New research shows that delivering on multicloud e...
On-premise or off, you have powerful tools available to maximize the value of your infrastructure and you demand more visibility and operational control. Fortunately, data center management tools keep a vigil on memory contestation, power, thermal consumption, server health, and utilization, allowing better control no matter your cloud's shape. In this session, learn how Intel software tools enable real-time monitoring and precise management to lower operational costs and optimize infrastructure...
While a hybrid cloud can ease that transition, designing and deploy that hybrid cloud still offers challenges for organizations concerned about lack of available cloud skillsets within their organization. Managed service providers offer a unique opportunity to fill those gaps and get organizations of all sizes on a hybrid cloud that meets their comfort level, while delivering enhanced benefits for cost, efficiency, agility, mobility, and elasticity.
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...