CEO Sam Cobb’s presentation will be titled “i-Bodies: A Novel Therapeutic Approach for IPF.” The three-day conference started Aug. 21.
“IPF is a disease with high unmet clinical need and we do believe AD-114 will provide the clinical community and patients with a much-needed new treatment option,” Cobb said in a press release. “That we’ve been invited to speak alongside world experts at the inaugural IPF Summit is immensely validating of the critical nature of our work.”
The U.S. Food and Drug Administration granted orphan drug status to AD-114 earlier this year. That designation, which covers treatments for rare and serious diseases, is aimed at accelerating a drug’s regulatory approval.
Preclinical-trial studies have shown that AD-114 reduced lung fibrosis in both the liver and lungs of mice with tissue scarring. The results prompted AdAlta to schedule the drug’s first clinical trial, which is scheduled to begin early next year.
AD-114 is a humanized version of an antibody in sharks. It belongs to a class of therapies called i-bodies, which are proteins that combine the features of small molecules and antibodies.
The drug targets a protein called chemokine receptor type 4 — or CXCR4 — that is found on the surface of cells called fibrocytes. These cells are present in unusual highly numbers in IPF, and correlate with higher patient death rates.
The binding of AD-114 to CXCR4 leads to the activation of pathways with anti-fibrotic and anti-inflammatory properties.
There is an urgent need for new IPF therapies. The first AD-114 clinical trial will demonstrate whether the promising effects that researchers observed in animal studies will also be seen in humans.
AdAlta is also testing AD-114 as a treatment for other fibrotic diseases.
“Although our focus with AD-114 is IPF, AD-114 has the potential to treat a wide range of fibrotic conditions, including wet age-related macular degeneration, of which there are 21,000 new cases diagnosed in Australia each year, and non-alcoholic fatty liver disease, which affects around 5.5 million Australians and is a precursor to nonalcoholic steatohepatitis (NASH),” Cobb said.