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.
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.
Approximately 85% of sub-study patients had OA of the knee; 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 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 Corp. holds exclusive development and commercial rights for fasinumab.
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 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 VelocImmunetechnology that yields optimized fully-human antibodies.
Fasinumab targets nerve growth factor, 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.
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.
Teva Pharmaceutical Industries is mainly in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory.
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