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altimmune Altimmune Announces Second Quarter 2021 Financial Results and Provides a Corporate Update August 10 , 2021 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 bio pharmaceutical 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 o 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 target o The multi - dose regimen was well - tolerated without the need for dose titration o No subject dropouts relate 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 o 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 administered o Data 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 homeostasis ■ Insulin resistance - HOMA - IR2 , adiponectin ■ Lipids ( HDL , LDL , TG , & lipoprotein ( a ) ) ■ Markers of inflammation • Filing of ALT - 801 investigational new drug ( IND ) application for non - alcoholic stea tohepatitis ( NASH ) on track for Q3 2021 , which will be followed by the initiation of a clinical trial in non - alcoholic fatty liver disease ( NAFLD ) o The Phase 1b , 12 - week NAFLD study will include diabetic and non - diabetic subjects and is expected to be conducted at approximately 10 US sites o Primary efficacy end point will be reduction in liver fat by MRI - PDFF o Study expected to enable a 52 - week biopsy driven NASH study in Q1 2022 • IND in obesity expected to be filed in Q4 2021 o Phase 2 obesity trial is expected to initiate in Q1 2022 o Development program expected to include diabetic and non - diabetic subjects • Additional clinical development to support NASH and obesity programs during 2021 o Phase 1 drug - drug interaction study to initiate in Q4 2021 to evaluate ALT - 801 interaction with commonly used drugs o 12 - week Phase 1 study to initiate in Q4 2021 to evaluate ALT - 801 effects on glucose control , hemoglobin A1C and insulin resistance in subjects with type 2 diabetes • Initiated development of an oral formulation for ALT - 801 o Molecular weight and potency of ALT - 801 are well - suited for oral administration