“The Alpha-1 Foundation is pleased with the FDA’s indication of a potential for accelerated approval of INHBRX -101. A1F values our strong working relationship with FDA leadership on behalf of our patient community and we are grateful to all of our partners focused on advancing efforts to improve the lives of Alphas.” – A1F President & CEO Scott Santarella
Inhibrx Inc. shares were up 42% to $28.70 in premarket trading Tuesday after the biopharmaceutical company said that based on discussions with the U.S. Food and Drug Administration, there is potential to pursue accelerated approval in the U.S. for INBRX-101.
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 that 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.
Read the MarketWatch article here: https://www.marketwatch.com/story/inhibrx-shares-jump-premarket-after-talks-with-fda-on-inbrx-101-271664889911
Read the Inhibrx press release here: https://inhibrx.investorroom.com/2022-10-04-Inhibrx-Announces-Opportunity-for-Accelerated-Approval-Pathway-on-Functional-AAT-Serum-Levels-for-INBRX-101-in-AATD-and-Announces-Bronchoalveolar-Lavage-Fluid-Detection-Results-from-the-Phase-1-Study