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Stock impact report

Tectonic Therapeutic reports findings from Phase Ia trial of TX45 [Yahoo! Finance]

Tectonic Therapeutic, Inc. (TECX) 
Company Research Source: Yahoo! Finance
A strong PK/PD relationship was established to identify Phase II doses and dosing regimens by assessing the change in renal plasma flow from baseline at various time points after dosing. In preclinical chronic pulmonary hypertension models, trough exposures associated with maximal activity also showed near-peak renal plasma flow increase on administering TX45. The PK/PD model derived from the Phase Ia data closely matched the relationship observed in preclinical studies when adjusted for potency differences between species, the company noted. Based on these models, Tectonic selected dose regimens for the Phase II proof of concept clinical trial in PH-HFpEF patients. The Phase II trial will randomise patients to 300mg subcutaneously once monthly, 300mg every other week, or placebo. Following the receipt of the US Food and Drug Administration's clearance of the investigational new drug application for TX45, subject screening in the Phase II APEX trial has commenced. The com Show less Read more
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