Inhibrx (NASDAQ:INBX) stock rose ~33% on Oct. 4 after the company said there was potential to pursue an accelerated approval in the U.S. for INBRX-101 to treat a lung disorder, after discussions with the U.S. Food and Drug Administration (FDA).
The company is developing INBRX-101 to treat patients with emphysema due to alpha-1 antitrypsin deficiency (AATD) and plans to begin potential registration-enabling trial using functional alpha-1 antitrypsin (AAT) serum levels as a surrogate endpoint with the intent to submit for regulatory approval under the FDA's Accelerated Approval Program.
AATD is a hereditary disorder characterized by low levels of the protein AAT. Certain people with this deficiency can develop a lung condition called emphysema.
Inhibrx said in an Oct. 4 release that the FDA emphasized the importance of being able to show INBRX-101's ability to maintain a trough level within the normal range of AAT in healthy individuals.
The FDA also requested additional data on the correlation between functional AAT levels and the clinical benefit in AATD to support serum AAT levels as a surrogate goal.
In addition, Inhibrx also announced the detection of INBRX-101 in the bronchoalveolar lavage fluid (BALF) samples from all 11 patients with AATD tested in a phase 1 study.
The company noted that on Oct. 3 it amended milestone terms of a last remaining tranche under its loan and security agreement with Oxford Finance to provide $30M upon the announcement of regulatory path for INBRX-101 rather than after starting of a potential registration-enabling trial of INBRX-101.
Inhibrx added that it has 30 days from this announcement to initiate this draw.