Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies.
Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD and LIFT-AD studies.
Athira expects topline data from the ACT-AD to be available in the first half of 2022.
ACT-AD is a six-month double-blind Phase 2 trial while LIFT-AD is a six-month double-blind Phase 2/3 study.
ATH-1017 is a subcutaneously delivered small molecule drug that can cross the blood-brain barrier. The drug is designed to improve the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The levels of both HGF and MET tend to be reduced in Alzheimer’s patients.
The company’s Aβ- and tau-agnostic strategy for treating Alzheimer’s is different from many other drug companies subscribing to the amyloid cascade hypothesis or tau hypothesis.
Prior Phase 1 research involving ATH-1017 found it to be well tolerated.
The company has also conducted preclinical research to test ATH-1017’s potential in Parkinson’s disease.
In October, the company announced that it had installed its former chief operating officer, Mark Litton, as CEO. The company’s former CEO, Leen Kawas, had resigned amidst allegations that she had manipulated images in at least four research papers published between 2011 and 2014.
Athira Pharma, initially known as M3 Biotechnology, first intended to commercialize Dihexa, a drug candidate discovered at Washington State University. Upon concluding that the drug did not have appropriate drug-like characteristics, the company investigated more than 50 compounds that activate the HGF/MET pathway. That research eventually led to the selection of ATH-1017, a prodrug to Dihexa. After subcutaneous administration, the body immediately converts ATH-1017 to an active metabolite in the plasma.
The company concluded that ATH-1017 has superior drug-like properties compared to Dihexa, including solubility and pharmacokinetics.
Athira won a patent for ATH-1017 in June.