Vertex Pharmaceuticals' (VRTX) New AAT Corrector Enters Clinic
Vertex Pharmaceuticals Incorporated VRTX announced that the FDA has allowed it to initiate the first clinical study on a new candidate, VX-634, targeting alpha-1 antitrypsin deficiency (AATD), a rare, genetic disease, which can cause liver and lung disease.
The FDA cleared the Investigational New Drug application for VX-634, a small molecule AAT corrector, thereby allowing Vertex to initiate a first-in-human clinical study in healthy volunteers.
Vertex’s stock has risen 34.4% this year so far against the industry’s decline of 28.3%.
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We remind investors that Vertex’s two candidates for AATD disease, VX-814 and VX-814, failed earlier. In October 2020, Vertex discontinued the phase II study on VX-814 for AATD, based on the liver enzyme elevations observed and the determination that it would be difficult to safely achieve targeted exposure levels. In June 2021, Vertex decided not to pursue late-stage development of VX-864 for AATD. The decision was taken despite a phase II study on the candidate achieving its primary endpoint. Though the data provided proof of mechanism, the company believed that the magnitude of the treatment effect observed in the study was unlikely to lead to any substantial clinical benefit and thus it was not feasible to advance it to pivotal development.
Vertex said that VX-634 is the first of the next set of molecules with better potency and drug-like properties than the older AAT correctors. Clinical studies on some other AAT correctors are expected to begin in 2023.
Additionally, Vertex will begin a 48-week phase II study of VX-864 in a few weeks’ time to evaluate if longer-term treatment with VX-864 can result in polymer clearance from the liver and lead to greater increases in functional AAT levels in the plasma. The earlier phase II study on VX-64 did not address the candidate’s effects on the levels of liver polymer, an important clinical endpoint.
Vertex currently sports a Zacks Rank #1 (Strong Buy).
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