Abion had said it completed patient enrollment for a phase 1 clinical trial of anticancer medicine. However, the ClinicalTrials.gov site recently showed that the study was still “recruiting” patients.
According to the site, operated by the U.S. National Institutes of Health, Abion changed the status of the ABN401 trial to “recruiting” on Feb. 25.
Abion is developing ABN401 as a c-MET treatment candidate. In addition, the company is preparing for a global phase 2 study to win an indication for non-small cell lung cancer (NSCLC).
On Feb. 2, Abion had said it completed the phase 1 trial of ABN401. At that time, the company announced that it selected Labcorp as a global contract research organization (CRO) for ABN401 development, saying it completed the global phase 1 study in Australia and Korea successfully and confirmed that the drug did not cause any Grade 3 or more severe adverse reactions.
Based on excellent safety data from the phase 1 study, the company will speed up the entry into the global phase 2 trial in the U.S., it added.
“We confirmed ABN401’s high safety and tolerability in the phase 1 study and secured excellent drug reaction data. So, we expect positive results in a phase 2 study, too,” said Shin Young-key, CEO of Abion, at the time.
The Ministry of Food and Drug Safety’s information site also showed that the status of the phase 1 trial of ABN401 is stated as “completed.”
However, considering the updated date on the ClinicalTrials.gov site, it is difficult to understand why the company said it ended the trial, investors of Abion, a Kosdaq-listed company, said.
Abion said it needed some time to confirm the facts regarding the issue.
Abion is scheduled to provide a poster presentation on the results of the preclinical trial of ABN501 at the meeting of the American Association for Cancer Research in April.
ABN501 targets Claudin 3, a frequently expressed protein in breast and ovarian cancers.
Abion confirmed the antibody-dependent cellular cytotoxicity (ADCC) activity of ABN501 in a cancer cell line expressing Claudin 3 and that the drug showed an antitumor effect in an animal model.