Adverum Biotechnologies(US:ADVM)2020-08-11 05:25Financial Data and Key Metrics Changes - The company reported robust treatment response and long-term durability beyond 15 months from a single injection of ADVM-022, with zero rescue injections in patients from Cohort 1 [11][45] - There was a substantial reduction in annualized anti-VEGF injection frequency, with a 100% reduction in the high dose cohort and an 87% reduction in the low dose cohorts [43][45] Business Line Data and Key Metrics Changes - ADVM-022 continues to show a favorable safety profile across all four cohorts, with low-grade inflammation that is manageable with topical steroid eye drops [32][45] - The OPTIC trial has completed enrollment, and the company plans to present additional data from Cohorts 1 to 4 by the end of the year [12][45] Market Data and Key Metrics Changes - The company is preparing to advance ADVM-022 for two significant ocular disease indications: wet AMD and DME, which represent a large global market opportunity [12][46] - The ongoing INFINITY trial for diabetic macular edema is designed to demonstrate superior disease control compared to a single aflibercept injection, addressing a major cause of blindness in working adults [46][47] Company Strategy and Development Direction - The company aims to revolutionize the treatment paradigm for ocular diseases with ADVM-022, focusing on a one-and-done approach to reduce treatment burden for patients [10][11] - Plans are in place to scale up manufacturing capabilities from 200 liters to 1,000 liters to support future commercial product launch [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of ADVM-022 to change the disease course for patients with neovascular AMD and highlighted the importance of continuous delivery in the context of the COVID-19 pandemic [11][16] - The leadership team is focused on expanding business operations and capabilities, including clinical, regulatory, and manufacturing functions, to prepare for a pivotal trial and potential commercial launch [14][15] Other Important Information - The company has experienced limited impact from COVID-19 on its operations and ongoing clinical trials, successfully completing enrollment in Cohort 4 of the OPTIC trial [16] - The management team emphasized the importance of patient-centric approaches and the emotional impact of treatment on patients and their families [49][50] Q&A Session Summary Question: Efficacy and Safety of ADVM-022 - The management noted that improvements in anatomy and central retinal thickness have been observed, indicating potential efficacy of continuous delivery [52][53] - Concerns regarding posterior inflammation were addressed, with management expressing confidence in the safety profile of ADVM-022 compared to other treatments [54][56] Question: Management of Topical Steroids - Management discussed the experiences of patients when tapering off topical steroids, noting that some patients may experience a rebound effect, but most have been able to discontinue with minimal issues [59][60][64] Question: Inflammation Concerns - The management acknowledged the importance of monitoring inflammation levels and emphasized that the majority of patients have experienced manageable inflammation that responds well to topical steroids [67][68]