Avalanche Biotechnologies comes out with positive Top-Line Phase 2a Results for AVA-101 Print E-mail
By William Kent   
Tuesday, 16 June 2015 15:21
Avalanche Biotechnologies has confirmed that the Phase 2a clinical study for AVA-101 has completed objectives of 12-month primary endpoint showing that it was well tolerated having wet age-related macular degeneration. AVA-101 also demonstrated improvement on best corrected visual acuity (BCVA) vis-a-vis the control group as well as positive trend in response rate. The AVA-101 would be providing sub-retinal gene therapy injection for giving safe and effective treatment for wet AMD.


Samuel B. Barone, M.D., Avalanche's chief medical officer, opined that the results show Phase 1 safety results adding to the fact that AVA-101 could benefit significant portion of patients having wet AMD needing regular treatment with anti-VEGF therapy.


He added that the present standard entails frequent anti-VEGF injections resulting in huge burden for patients as well as their caregivers. Hence, this product may improve vision along with lowering number of treatment injections showing powerful new option for patients.


Thomas W. Chalberg, Jr., Ph.D., Avalanche's co-founder and chief executive officer, opined that AVA-101 showed promise in treating effect in subjects treated in the study. He added that the data would aid in informing future study designs such as Phase 2b study which would be done later in the year.


The Phase 2a study had 32 subjects age 55 or older. All subjects were in the study mode throughout 12 month study visit. No adverse effects were observed. Even though the study was not made for showing significant differences between control and active subjects in secondary endpoints, some results were observed.


The data from the study would be shown at upcoming medical conferences this year and it would help the firm make design of Avalanche's Phase 2b AVA-101 study that the firm aims to conduct at multiple centers in the United States.

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