Business
Altimmune Announces Second Quarter 2021 Financial Results and Provides a Corporate Update
12-week Data Readout from ALT-801 Phase 1 Clinical Trial Expected in September Approximately $218 Million in Cash and Short-Term Investments to Advance
About this update from Altimmune, Inc.
[{"type":"text","content":"12-week Data Readout from ALT-801 Phase 1 Clinical Trial Expected in September Approximately $218 Million in Cash and Short-Term Investments to Advance Obesity and Liver Disease Pipeline GAITHERSBURG, Md., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the three- and six-months ending June 30, 2021 and provided a corporate update. “Following data readouts in Q2, Altimmune has focused its efforts on our NASH and emerging obesity pipeline with the encouraging interim data from the ALT-801 Phase 1 trial reinforcing the potential of these programs,” remarked Vipin K. Garg, Ph.D., President and Chief Executive Officer at Altimmune. “Our strong financial position enables us to proceed with a robust ALT-801 development program in the second half of 2021 with the goal of initiating Phase 2 trials in early 2022 for both obesity and NASH indications.” Recent Highlights: Reported encouraging 6-week interim data from the ongoing Phase 1 clinical trial of ALT-801 in Australia In the study of overweight and obese subjects, a placebo-adjusted weight loss of 6.3% was achieved at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing the 2% pre-established treatment targetThe multi-dose regimen was well-tolerated without the need for dose titrationNo subject dropouts related to drug administration reported within the first 6 weeks of treatment Advancing to ALT-801 12-week data readout on three cohorts, expected in September 2021 12-week data on three dose cohorts at the 1.2mg, 1.8mg and 2.4mg dose levels are expected to be reported. The final 12-week dose for all cohorts has been administeredData readouts are expected to include update on weight loss and adverse events, in addition to the following measures: Pharmacokinetics (PK)Lean body mass, calorie intake, resting energy expenditure (REE)Glucose homeostasisInsulin resistance—HOMA-IR2, adiponectinLipids (HDL, LDL, TG, & lipoprotein (a))Markers of inflammation Filing of ALT-801 investigational new drug (IND) application for non-alcoholic steatohepatitis (NASH) on track for Q3 2021, which will be followed by the initiation of a clinical trial in non-alcoholic fatty liver disease (NAFLD) The Phase 1b, 12-week NAFLD study will include diabetic and non-diabetic subjects and is expected to be ...