Avalanche Biotechnologies tanks on decision not to proceed to Phase IIb with AVA-101

Shares of US biotech firm Avalanche Biotechnologies (Nasdaq: AAVL) plunged 27.6% to $10.01 on Friday, after the company unexpectedly reported that, following further analyses of results from a previously reported Phase IIa trial of AVA-101 for the potential treatment of wet age-related macular degeneration (wet-AMD), it will not initiate a Phase IIb clinical trial in the second half of 2015.

In June, the company reported that AVA-101 met its primary endpoint of maintaining visual acuity with fewer anti-VEGF injections compared to a control group (The Pharma Letter June 17).

Instead, Avalanche will conduct additional preclinical studies to investigate optimal dose and delivery of AVA-101 and AVA-201 versus standard of care anti-VEGF protein therapy to select the best gene therapy product candidate for wet AMD to advance back into the clinic. This decision was based on more detailed analyses of the Phase IIa clinical trial data, which included individual subject-level assessment of anatomic and functional outcomes, treatability of the Phase IIa subjects and product administration.