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Jun 30, 2020
Adverum Q2 2020 Earnings Report
Announced positive interim data from OPTIC Phase 1 trial, reported recent business progress, and second quarter 2020 financial results.
Key Takeaways
Adverum Biotechnologies announced positive interim data from the OPTIC Phase 1 clinical trial of ADVM-022 for wet AMD. The company reported recent business progress and financial results for the second quarter ended June 30, 2020. They also completed dosing patients in OPTIC, with 30 patients being followed up across four cohorts, and plan to seek regulatory input as they progress towards initiating a pivotal clinical trial in mid-2021.
ADVM-022 continues to show robust treatment response with maintained mean BCVA and CRT.
Long-term durability beyond 15 months from a single IVT injection was observed with zero anti-VEGF rescue injections in Cohort 1.
A dose response was further evidenced with high dose patients being rescue injection free.
ADVM-022 continues to be well tolerated with a favorable safety profile in all 4 cohorts.
Adverum
Adverum
Forward Guidance
Adverum plans to present clinical data from OPTIC Phase 1 trial by year-end 2020 and initiate a pivotal trial mid-2021. They will also present clinical data from INFINITY in the second half of 2021 and are initiating process scale-up from 200L to 1000L scale.
Positive Outlook
- Present clinical data from Cohorts 1-4 of OPTIC Phase 1 trial by year-end 2020
- Initiate a pivotal trial mid-2021 for ADVM-022 in wet AMD
- Present clinical data from INFINITY in the second half of 2021
- Initiating process scale-up from 200L to 1000L scale to support the future commercial product launch of ADVM-022
- Beginning to plan for in-house GMP capabilities with initiation of site selection
Challenges Ahead
- Reliance on third parties for conducting the OPTIC and INFINITY trials and vector production
- The effects of the COVID-19 pandemic on the company’s operations and on the company’s ongoing clinical trials
- Adverum’s novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval
- The potential for preliminary or interim results of clinical trials to change as the clinical trial continues or in connection with the preparation and analysis of final results
- The potential for future complications or side effects in connection with use of ADVM-022