Applied Therapeutics Reports AT-007 SAD Data from Healthy Volunteer Portion of Phase 1/2 ACTION-Galactosemia Study
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: GlobeNewswire
NEW YORK, Aug. 08, 2019 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing novel drug candidates in indications of high unmet medical need, today announced the completion of the Single Ascending Dose (SAD) healthy volunteer portion of the Phase 1/2 study of AT-007 in Galactosemia (ACTION-Galactosemia). The results show that AT-007 was well tolerated, with no drug-related adverse events or dose-limiting toxicities reported. The SAD study treated 4 cohorts of 8 subjects each and explored doses from 0.5mg/kg to 20mg/kg. In addition to safety, AT-007 demonstrated a linear pharmacokinetic (PK) profile, favorable exposure, and half-life consistent with once-daily dosing. “We are encouraged by the favorable safety profile in healthy volunteers, and we look forward to advancing AT-007 through the MAD study in healthy volunteers and to the Phase 2 portion of the study in patients with Galactosemia,” said Riccardo Per
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