Date: 2016-08-08
Type of information: Results
phase: 1-2
Announcement: results
Company: Pfenex (USA - CA)
Product: PF582 ( biosimilar ranibizumab )
Action
mechanism: biosimilar monoclonal antibody. Ranibizumab is VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Disease: age related macular degeneration (AMD)
Therapeutic area: Ophtalmological diseases
Country: New Zealand
Trial
details: The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis® (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1, 28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the study participants will undergo the following procedures: height, weight and vital signs (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical history and concomitant medications; adverse event monitoring; physical examinations; eye tests (reading chart, measurement of retinal thickness [via pictures of the retina] and examination of the eye's blood vessels, via pictures taken following injection of a dye into the arm), blood collection and a urine pregnancy test, where applicable. (NCT02121353)
Latest
news: * On August 8, 2016, Pfenex announced PF582 phase 1/2 safety and efficacy data. This first-in-human study met its primary objective of demonstrating similar safety and tolerability between PF582 and Lucentis®. Additionally, it demonstrated consistent pharmacological activity between PF582 and Lucentis®. The company has enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular age-related macular degeneration (AMD) in the PF582 phase 1/2 trial (13 received PF582, including 1 sentinel patient who received open label PF582, 12 received Lucentis®). All patients received 3 monthly intravitreal injections. The primary endpoint of the study was safety and tolerability of PF582 compared to that of Lucentis® in patients with neovascular AMD. With respect to safety, there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis® at any of the timepoints. Additionally, there were no imbalances in local or systemic adverse events and no unexpected safety or tolerability findings in the population studied. The efficacy and pharmacodynamic results indicated that there were no meaningful differences in best corrected visual acuity and the decreases in central retinal thickness between PF582 and Lucentis® at any of the timepoints were also similar. The immunogenicity results showed comparable anti-drug antibody findings between PF582 and Lucentis® throughout the three month study period.
