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Regeneron's Eylea/Rinucumab Combination Data Disappoints
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced disappointing top-line data from an ongoing phase II CAPELLA study, evaluating Eylea (aflibercept) in combination with rinucumab (an anti-PDGFR-beta antibody), in patients suffering from neovascular age-related macular degeneration (wet AMD).
The double-masked, randomized, controlled, multiple-dose, regimen-ranging study enrolled about 500 patients with wet AMD, who received either Eylea monotherapy 2 mg, Eylea 2 mg/rinucumab 1 mg or Eylea 2 mg/rinucumab 3 mg. Data revealed that patients in both Eylea/rinucumab combination groups witnessed a 5.8 letter improvement in best corrected visual acuity (BCVA) while those who received Eylea alone demonstrated a 7.5 letter improvement in BCVA at 12 weeks, thereby failing to meet the primary endpoint of the study.
Moreover, no benefit on anatomic endpoints including reduction in retinal thickness, or in resolution of sub-retinal hyper-reflective material were observed when rinucumab was added to Eylea. Also, ocular adverse events at 12 weeks were found to be more common in the combination treatment groups (23.5 and 20%) in comparison to Eylea alone (16%), largely driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.
Regeneron plans to evaluate data at 28 weeks and 52 weeks, once the study is completed. The company intends to present additional data at an upcoming medical congress.
We note that Eylea, which is approved for several eye disorders, is the key growth driver at Regeneron. Considering that the company is looking to expand Eylea’s label into additional indications, the reported study results are unimpressive. Meanwhile, combination studies on Eylea and nesvacumab (an anti-angiopoietin 2 antibody) are currently underway.
We note that Ophthotech Corporation is developing Fovista (also an anti-PDGF therapy) in combination with multiple anti-VEGF agents (including Eylea, Lucentis and Avastin) in phase III studies, for the treatment of wet AMD saw its shares plunge 14.8% on the news. The company is expected to report data from a couple of phase III studies on Fovista in the current quarter.
Dupixent Phase III Data Published
In a separate press release, Regeneron and partner Sanofi (SNY - Free Report) announced that detailed results from two placebo-controlled phase III studies – LIBERTY AD SOLO 1 and SOLO 2 – evaluating Dupixent (dupilumab) in adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in the New England Journal of Medicine.
Both studies met their primary endpoints, and Dupixent demonstrated a significant reduction in the signs and symptoms of AD, and showed improvement in studied quality of life measures.
We note that Dupixent is currently under priority review in the U.S. with a response from the FDA expected by Mar 29, 2017. Apart from AD, Dupixent is being evaluated for additional inflammatory indications including asthma, nasal polyposis and eosinophilic esophagitis.
For 2016, Anika witnessed a 9.5% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped 25.7% year to date.
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Regeneron's Eylea/Rinucumab Combination Data Disappoints
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced disappointing top-line data from an ongoing phase II CAPELLA study, evaluating Eylea (aflibercept) in combination with rinucumab (an anti-PDGFR-beta antibody), in patients suffering from neovascular age-related macular degeneration (wet AMD).
The double-masked, randomized, controlled, multiple-dose, regimen-ranging study enrolled about 500 patients with wet AMD, who received either Eylea monotherapy 2 mg, Eylea 2 mg/rinucumab 1 mg or Eylea 2 mg/rinucumab 3 mg. Data revealed that patients in both Eylea/rinucumab combination groups witnessed a 5.8 letter improvement in best corrected visual acuity (BCVA) while those who received Eylea alone demonstrated a 7.5 letter improvement in BCVA at 12 weeks, thereby failing to meet the primary endpoint of the study.
Moreover, no benefit on anatomic endpoints including reduction in retinal thickness, or in resolution of sub-retinal hyper-reflective material were observed when rinucumab was added to Eylea. Also, ocular adverse events at 12 weeks were found to be more common in the combination treatment groups (23.5 and 20%) in comparison to Eylea alone (16%), largely driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.
Regeneron plans to evaluate data at 28 weeks and 52 weeks, once the study is completed. The company intends to present additional data at an upcoming medical congress.
We note that Eylea, which is approved for several eye disorders, is the key growth driver at Regeneron. Considering that the company is looking to expand Eylea’s label into additional indications, the reported study results are unimpressive. Meanwhile, combination studies on Eylea and nesvacumab (an anti-angiopoietin 2 antibody) are currently underway.
We note that Ophthotech Corporation is developing Fovista (also an anti-PDGF therapy) in combination with multiple anti-VEGF agents (including Eylea, Lucentis and Avastin) in phase III studies, for the treatment of wet AMD saw its shares plunge 14.8% on the news. The company is expected to report data from a couple of phase III studies on Fovista in the current quarter.
Dupixent Phase III Data Published
In a separate press release, Regeneron and partner Sanofi (SNY - Free Report) announced that detailed results from two placebo-controlled phase III studies – LIBERTY AD SOLO 1 and SOLO 2 – evaluating Dupixent (dupilumab) in adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in the New England Journal of Medicine.
Both studies met their primary endpoints, and Dupixent demonstrated a significant reduction in the signs and symptoms of AD, and showed improvement in studied quality of life measures.
We note that Dupixent is currently under priority review in the U.S. with a response from the FDA expected by Mar 29, 2017. Apart from AD, Dupixent is being evaluated for additional inflammatory indications including asthma, nasal polyposis and eosinophilic esophagitis.
Regeneron is a Zacks Rank #2 (Buy) stock.
Zacks Rank & Stock to Consider
A favorably ranked stock in the health care sector is Anika Therapeutics Inc. (ANIK - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
For 2016, Anika witnessed a 9.5% increase in its earnings estimates over the past 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped 25.7% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>