Adverum Biotechnologies Inc. (NASDAQ:ADVM) has announced the commencement of its second phase INFINITY study. The study is a randomized, multi-center, double-blind, placebo-controlled study evaluating a single ADVM-022 intravitreal injection (IVT) in treatment of diabetic macular edema (DME) patients.
Adverum initiates second phase INFINITY evaluating ADVM-022 in DME
The company has designed the INFINITY study to show enhanced disease activity control through a single ADVM-022 IVT injection. This is in comparison to a single aflibercept injection measured during the time of the deteriorating disease activity of DME. The study will enroll around 33 patients. Adverum will randomize subjects in the double-blind trial into three arms for the study of eye treatment. They will administer a high dose ADVM-022 in Arm 1 at 6×1011 vg while those in Arm 2 will be given a lower ADVM-022 dose at 2×1011 vg. In Arm 3, participants will receive a 2mg dose of aflibercept.
The company’s CEO and President Leone Patterson said that they were delighted about the efforts Adverum employees have been putting to advance its pipeline. This is despite the challenges the coronavirus pandemic has brought. Leone indicated that they have continued to execute their objective of developing and commercializing ADVM-022. ADVM-022 is novel gene therapy being advanced as a one-off wet age-related AMD and DME treatment, which are the main anti-VEGF treatment indications. The CEO confirmed that ADVM-022 was recently granted IND, which advised the commencement of the INFINITY study.
Adverum has adequate cash to run operations to 2022
The company has also announced its Q1 results for the quarter that ended on March 31, 2020. The company had $297.1 million in cash and cash equivalents as well as investments in the quarter compared to the previous quarter when it had $166 million. In February, the company raised around $149.9 million in proceeds through an underwritten public offering.
Net loss in the quarter was $22.9 million or 31 cents per diluted and basic share. The company indicated that it has enough cash at hand to fund operations through 2022.