Altimmune Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
On March 13, 2025, Altimmune, Inc. (the “Company”) announced that the Company is pursuing two additional indications for its lead product candidate, pemvidutide. The new indications are Alcohol Use Disorder (“AUD”) and Alcohol-Associated Liver Disease (“ALD”), also known as Alcohol Liver Disease and Alcohol-Related Liver Disease.
AUD is a chronic disease characterized by uncontrolled drinking. In addition to the underlying alcohol misuse by AUD patients, AUD patients have comorbidities that pose significant treatment and management challenges (including steatosis, obesity, hypertension and hyperlipidemia). The Company expects to begin a Phase 2 AUD trial for pemvidutide in the second quarter of 2025. The planned trial will be a randomized, double-blind, placebo-controlled trial of approximately 100 subjects with moderate to severe AUD over a 24-week period. Endpoints will include change in heavy drinking days, change in biomarkers of alcohol consumption and weight loss.
ALD is a condition that damages the liver due to excessive, chronic alcohol use. ALD progression (like metabolic dysfunction-associated steatohepatitis (MASH) progression), begins with liver steatosis, which may lead to fibrosis, and ultimately to cirrhosis. The Company expects to begin a Phase 2 ALD trial for pemvidutide in the third quarter of 2025. The planned trial will be a randomized, double-blind, placebo-controlled trial of approximately 100 subjects with obesity and ALD over a 48-week period. Endpoints will include change in liver stiffness, change in alcohol consumption, and biomarkers of steatosis and liver fibrosis and inflammation.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ALTIMMUNE, INC. | |||
By: |
| /s/ Gregory Weaver | |
| Name: Gregory Weaver | ||
| Title: Chief Financial Officer | ||
Dated: March 13, 2025