Data include final primary efficacy results and an interim safety analysis
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary efficacy analysis, the study met both co-primary endpoints and all key secondary endpoints. Fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.
“We are encouraged by these data and look forward to advancing our pivotal Phase 3 fasinumab program in patients with osteoarthritis of the knee or hip, who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steriodal anti-inflammatory drugs or opioids,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
The study compared two different fasinumab treatment arms (subcutaneous 1 mg every four or eight weeks) with placebo. The co-primary endpoint results are presented in Table 1.
Table 1: Topline Efficacy Results from Phase 3 Study1
|Fasinumab 1 mg||Fasinumab 1 mg|
|every 8 weeks||every 4 weeks|
|Change in pain at week 16 vs.||-1.56||-2.25||-2.78|
baseline (least squares [LS] mean)2
|Change in physical function at week||-1.37||-2.10||-2.57|
16 vs. baseline (LS mean)3
1. Approximately 85% of sub-study patients had OA of the knee; 2. As measured by the Western Ontario and McMaster Universities Osteorarthritis Index (WOMAC) pain subscale score (score range: 0-10); 3. As measured by the WOMAC physical function subscale score (score range: 0-10)
After the primary efficacy assessment at week 16, patients continue on therapy for an additional 36 weeks, followed by a subsequent 20-week off study drug follow-up period for further safety assessment.
Interim safety data indicate that fasinumab was generally well tolerated, with similar adverse events (AEs) as those observed in previous fasinumab trials. At week 16, treatment discontinuations due to AEs had occurred in 6% of the placebo group patients, 5% of the fasinumab 1 mg every eight weeks group patients and 6% of the fasinumab 1 mg every four weeks group patients. The fasinumab safety program was designed to capture all arthropathies (joint damage), including those identified due to symptoms and those identified by regularly-scheduled radiographic monitoring, the first of which was scheduled at week 24. Among the approximately 65% of patients who had completed their first radiographic assessment, the placebo-adjusted rate of adjudicated arthropathies was approximately 2%. The majority of arthropathies were captured by the regularly-scheduled radiographic monitoring and involved isolated joint space narrowing, called RPOA-1 (rapid progressive OA type 1). No cases of osteonecrosis have been identified to date in this study.
The companies plan to present detailed results at an upcoming medical congress.
Regeneron and Teva are jointly developing fasinumab as part of a global collaboration agreement. In Japan and 10 other Asian countries, Mitsubishi Tanabe Pharma Corporation holds exclusive development and commercial rights for fasinumab.
About the Phase 3 Study
The Phase 3 study is a sub-study of a larger, long-term trial that involves 52 weeks of active treatment, designed to determine the safety and tolerability of fasinumab, including AEs of special interest, in patients with pain due to radiographically-confirmed OA of the knee or hip. Approximately 85% of sub-study patients had OA of the knee. The primary efficacy data were assessed at 16 weeks; the primary safety analysis of the larger long-term trial will occur at 72 weeks (52-week active treatment and 20-week follow-up periods). The safety data presented today are interim data and preliminary in nature. Earlier this year, an Independent Data Monitoring Committee (IDMC) monitoring the safety and efficacy of ongoing fasinumab trials recommended that the two higher dose regimens (3 mg every four weeks and 6 mg every eight weeks) be discontinued.
Fasinumab is an investigational therapy invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human antibodies. Fasinumab targets nerve growth factor (NGF), a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in the synovial fluid of patients with chronic pain conditions.
Regeneron and Teva are currently enrolling patients with chronic pain caused by OA of the knee or hip in three Phase 3 clinical trials including one assessing fasinumab long-term safety and two trials comparing fasinumab to standard pain therapies. The safety and efficacy of fasinumab have not been fully evaluated by any regulatory authority.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding fasinumab, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
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