Inhibrx Shares Rise 33% After FDA Talks on INBRX-101
October 04 2022 - 12:46PM
Dow Jones News
By Chris Wack
Inhibrx Inc. shares were up 33% to $26.85 after the company said
that based on discussions with the U.S. Food and Drug
Administration, there is potential to pursue an accelerated
approval in the U.S. for INBRX-101.
The stock closed Monday up 12%, and is up 132% in the last three
months.
INBRX-101 is an optimized recombinant human AAT-Fc fusion
protein for patients with emphysema due to alpha-1 antitrypsin
deficiency using functional alpha-1 antitrypsin serum levels as the
surrogate endpoint.
Inhibrx also said it detected INBRX-101 in the bronchoalveolar
lavage fluid samples from all alpha-1 antitrypsin deficiency
patients tested in the Phase 1 study.
The company said it plans to initiate in the first quarter of
2023 a potential registration-enabling clinical trial using
functional AAT as a surrogate endpoint with the intent to submit
for regulatory approval under the FDA's accelerated approval
program. The FDA expressed support to collaborate and work with
Inhibrx to address the regulatory challenges associated with AATD
drug development, the company said.
It said the FDA emphasized the importance of being able to
demonstrate 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
further support serum AAT levels as a surrogate endpoint that is
reasonably likely to predict clinical benefit, the prerequisite for
accelerated approval, Inhibrx said.
On Monday, the company amended the milestone terms of the last
remaining tranche under its loan and security agreement with Oxford
Finance LLC to provide for the funding of $30 million upon the
announcement of the regulatory path for INBRX-101 rather than upon
the initiation of a potential registration-enabling clinical trial
of INBRX-101. The company has 30 days from this announcement to
initiate this draw.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 04, 2022 12:31 ET (16:31 GMT)
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