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Replies to post #160724 on Biotech Values
05/03/13 2:54 PM
06/30/14 10:08 AM
• Announces Positive Phase 2 Data for Abicipar Pegol (Anti-VEGF DARPin) and Advances to Phase 3 Trials [see details below]
• Advances Bimatoprost Sustained-Release Implant for Glaucoma to Phase 3 Trials
• Receives FDA Approval for OZURDEX (dexamethasone intravitreal implant) 0.7 mg as Treatment Option for Diabetic Macular Edema (DME) in Certain Patients
• Receives Complete Response Letter for SEMPRANA (dihydroergotamine) Inhalation Aerosol
Anti-VEGF DARPin
Allergan has completed the topline analysis of data from the Company’s Stage 3, Phase 2 study of abicipar pegol (Anti-VEGF DARPin®) in neovascular, or “wet,” age-related macular degeneration (AMD). These data along with data from previous studies were reviewed with the FDA at an end of a Phase 2 meeting where the FDA supported Allergan’s decision to advance abicipar pegol to Phase 3 clinical trials and agreed with the proposed Phase 3 study plan.
The abicipar pegol Stage 3, Phase 2 study was designed to, in addition to assessing safety and efficacy, determine the appropriate dose of abicipar pegol that would provide equal or better visual acuity improvement but require less frequent injections than ranibizumab (LUCENTIS®). In the double-masked trial, a total of 64 patients were randomized to abicipar pegol 1mg (n=25), abicipar pegol 2mg (n=23) or ranibizumab 0.5mg (n=16) and were followed for 20 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients in the ranibizumab arm of the study received additional doses at 12 and 16 weeks. Patients who were treated with either dose of abicipar pegol received sham injections at 12 and 16 weeks. Patients in all arms of the study were well matched for demographics and baseline characteristics.
The analysis of the topline data showed that after 16 weeks, mean visual acuity improvement from baseline was 8.2 letters for abicipar pegol 2mg, 6.3 letters for abicipar pegol 1mg, and 5.3 letters for ranibizumab. After 20 weeks, (12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection) mean visual acuity improvement from baseline was 9.0 letters for abicipar pegol 2mg, 7.1 letters for abicipar pegol 1mg, and 4.7 letters for ranibizumab. In addition, Optical Coherence Tomography (OCT) data was supportive of the visual acuity data. Although the study was not powered to show statistically significant differences between treatment groups, and further data will be completed and submitted to the FDA, these data suggest that abicipar at the 2mg dose is at least as effective as monthly ranibizumab with a longer duration of action.
There were no serious adverse events reported in any study group. Two patients in the abicipar pegol 2mg arm and three patients in the abicipar pegol 1mg group experienced ocular inflammation adverse events. The complete data from the Stage 3, Phase 2 study will be presented at a retina meeting in the second half of 2014.
Allergan has been working to enhance the manufacturing process for abicipar pegol and will initiate Phase 3 studies in the second quarter of 2015, when material from the new manufacturing process is available. In the phase 3 program, Allergan will compare abicipar 2mg dosed every 8 weeks, abicipar 2mg dosed every 12 weeks and ranibizumab dosed every 4 weeks. All patients in the phase 3 program will receive three loading doses of drug.
