INBRX-101

INBRX-101 is an Fc-fusion protein-based therapeutic candidate comprising a modified recombinant version of human alpha-1 antitrypsin, or AAT, that we are developing for the treatment of patients with alpha-1 antitrypsin deficiency, or AATD. AATD is a genetically defined rare respiratory disease characterized by progressive destruction of lung tissue that has an FDA approved diagnostic. 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 has been unchanged for decades and relies on weekly infusions of plasma derived AAT, or pdAAT, therapeutics. There are currently approximately 10,000 AATD patients worldwide receiving plasma-derived augmentation therapies, translating into an estimated worldwide market of $1.2 billion in 2016 that is expected to grow to $2.9 billion by 2025. AAT has proven difficult to develop recombinantly, often displaying loss of activity and experiencing accelerated degradation. INBRX-101 is designed to offer superior clinical activity to pdAAT by providing sustained enhanced plasma concentration with a less frequent, monthly dosing regimen. The IND for INBRX-101 became effective in November 2018, and we expect to initiate a Phase 1 dose escalation clinical trial in the first half of 2019. We expect to announce initial results from this trial in the first half of 2020.