SAN DIEGO /PRNewswire/ -- Inhibrx, Inc. (Inhibrx), a clinical-stage biotechnology company focused on developing a broad pipeline of novel biologic therapeutic candidates, announced today the enrollment of the first patient in a Phase 1 clinical trial of INBRX-101 (NCT03815396). INBRX-101 is an Fc-fusion protein-based therapeutic candidate comprised of a modified recombinant version of human alpha-1 antitrypsin (AAT) for the treatment of patients with alpha-1 antitrypsin deficiency (AATD).
AATD is a genetically defined rare respiratory disease characterized by the progressive destruction of lung tissue that leads to COPD and emphysema. According to the Alpha-1 Foundation, this disease affects roughly 100,000 people in the United States and approximately the same number of people in Europe. The current standard of care for patients with AATD, plasma derived augmentation therapy (pdAAT), has been unchanged for decades and relies on weekly infusions of plasma derived AAT purified from human donor serum. INBRX-101 is designed to offer superior clinical activity to pdAAT by providing sustained enhanced plasma concentration with a less frequent, monthly dosing regimen.
"We applied our proprietary protein engineering capabilities to overcome the challenges of producing functional recombinant AAT, in addition to identifying modifications that we believe have the potential to optimize the PK profile and functionality," said Mark Lappe, CEO of Inhibrx. "Accordingly, we are pleased to begin enrollment in the Phase 1 trial to investigate the potential benefit of INBRX-101 in patients suffering from AATD."
Inhibrx expects to announce preliminary functional pharmacokinetic (PK) data from the single dose escalation portion of this trial in the first half of 2020.
Forward Looking Statements
Certain statements in this press release are forward looking statements that involve a number of risks and uncertainties. These statements include statements about Inhibrx's strategy, therapeutic candidates, sdAb platform and preclinical and clinical programs. These statements represent Inhibrx's judgements and expectations as of the date of this release. Actual results may differ due to a number of factors, including, but not limited to, the potential success and efficacy of Inhibrx's therapeutic candidates, the timing and success of its clinical studies, the timing of receipt of fees and payments, if any, from Inhibrx's collaborators and its ability to obtain funding as needed to support its operations. Inhibrx disclaims any intent or obligation to update these forward looking statements, other than as may be required by applicable law.
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