Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced topline results from the Phase 2 CAPELLA study evaluating aflibercept co-formulated with rinucumab, an anti-platelet-derived growth factor receptor beta (anti-PDGFR-beta) antibody, in patients with neovascular age-related macular degeneration (wet AMD). The combination therapy did not demonstrate an improvement in best corrected visual acuity (BCVA) compared to intravitreal aflibercept injection monotherapy at 12 weeks, the primary endpoint of the study. At 12 weeks, patients in both combination aflibercept/rinucumab groups showed a 5.8 letter improvement in BCVA. Patients treated with aflibercept alone showed a 7.5 letter improvement in BCVA.
“EYLEA® (aflibercept) injection is an established, effective therapy that has set a high bar in the treatment of wet AMD,” said George D. Yancopoulos M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “The addition of rinucumab did not improve on the efficacy of aflibercept alone. We are committed to continuing to innovate for patients with serious vision-threatening diseases, and look forward to the results of our ongoing combination studies of aflibercept and nesvacumab, an anti-angiopoietin 2 antibody, for which the preclinical data is more supportive.”
EYLEA results in this study were consistent with the efficacy and safety seen in Phase 3 pivotal studies in wet AMD. The efficacy results in the CAPELLA trial were consistent across all choroidal neovascularization (CNV) subtypes. Adding rinucumab to aflibercept showed no benefit on anatomic endpoints including reduction in retinal thickness or in resolution of subretinal hyper-reflective material. Ocular adverse events at 12 weeks were more common in the combination treatment groups (23.5 and 20 percent) compared to aflibercept alone (16 percent), primarily driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.
The ongoing Phase 2, double-masked, randomized, controlled, multiple-dose, regimen-ranging study has enrolled approximately 500 patients with wet AMD. Efficacy was evaluated using the Early Treatment Diabetic Retinopathy Scale (ETDRS) BCVA. Patients were randomized into one of three groups and received fixed doses every four weeks of either aflibercept monotherapy 2mg, aflibercept 2mg/rinucumab 1mg or aflibercept 2mg/rinucumab 3mg. The co-formulation was administered as a single intravitreal injection. At week 12, two of the three treatment groups were re-randomized, resulting in five total dosing groups in the second phase of the study. Data will be evaluated at 28 weeks and again at 52 weeks, when the study is completed.
More detailed results will be submitted for presentation at a future medical congress. (Original Source)
Shares of Regeneron closed yesterday at $406.36, down $12.74 or -3.04%. REGN has a 1-year high of $592.59 and a 1-year low of $329.09. The stock’s 50-day moving average is $405.46 and its 200-day moving average is $390.56.
On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report issued on September 27, Wells Fargo analyst Jim Birchenough maintained a Hold rating on REGN. Separately, on September 26, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $520.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jim Birchenough and Joseph Pantginis have a total average return of 22.0% and 7.2% respectively. Birchenough has a success rate of 53% and is ranked #79 out of 4200 analysts, while Pantginis has a success rate of 38% and is ranked #372.
Overall, 9 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $480.20 which is 18% above where the stock closed yesterday.
Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. The company involves in marketing medicines for eye diseases, colorectal cancer and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma and atopic dermatitis. Its products include EYLEA (aflibercept) injection, which is used for the treatment of neovascular age related macular degeneration; ARCALYST (rilonacept), which is used for the treatment of Cryopyrin-Associated Periodic Syndrome, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome; and PRALUENT (alirocumab) Injection for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL- C.