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
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...
SYS-CON Events announced today that Outscale will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outscale's technology makes an automated and adaptable Cloud available to businesses, supporting them in the most complex IT projects while controlling their operational aspects. You boost your IT infrastructure's reactivity, with request responses that only take a few seconds.
We all know that end users experience the internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices - not doing so will be a path to eventual ...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus intern...
Apache OpenWhisk on IBM Bluemix provides a powerful and flexible environment for deploying cloud-native applications driven by data, message, and API call events. In his session at 20th Cloud Expo, Daniel Krook, Software Architect, IBM Watson and Cloud Platform, and Distinguished IT Specialist, will discuss why serverless architectures are attractive for many emerging cloud workloads and when you should consider OpenWhisk for your next project. Then get started on Bluemix with three sample appl...
While presenting own advanced Robo-Advisory Platform, Michał Różański, Managing Partner at EARP and CEO at Empirica, will illustrate the most important issues of building tailored FinTech software in his session at 20th Cloud Expo. He will share experiences we have gained for over 6 years of developing solutions for financial institutions and FinTech companies, including robo-advisors. We welcome all FinTech innovators interested in how properly implemented technology can move their businesses f...
The 21st International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Internet of @ThingsExpo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 21st International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo Silicon Valley Call for Papers is now open.
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Automation is enabling enterprises to design, deploy, and manage more complex, hybrid cloud environments. Yet the people who manage these environments must be trained in and understanding these environments better than ever before. A new era of analytics and cognitive computing is adding intelligence, but also more complexity, to these cloud environments. How smart is your cloud? How smart should it be? In this power panel at 20th Cloud Expo, moderated by Conference Chair Roger Strukhoff, pane...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...