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Tectonic Therapeutic Announces Favorable Phase 1 Safety, Tolerability and PK Results for TX2100, a Novel Approach for the Treatment of Hereditary Hemorrhagic Telangiectasia (HHT)

Globe Newswire•29/09/2026•08:00 ET
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* U.S. FDA has granted Fast Track designation for TX2100 in HHT and cleared the Investigational New Drug (IND) application for the TX2100 Phase 1b clinical trial in HHT patients in the U.S. * TX2100 Phase 1a clinical trial topline results demonstrated single ascending doses of TX2100 were generally safe and well-tolerated in healthy adult volunteers * Company plans to initiate an open-label TX2100 Phase 1b clinical trial in patients with hematologic-support dependent HHT by year-end 2026, and initiate a Phase 2 clinical trial in parallel in patients with moderate-to-severe HHT in early 2027 WATERTOWN, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced favorable topline results from its Phase 1a clinical trial evaluating TX2100, an investigational VHH-Fc fusion antagonist antibody targeting the APJ (apelin) receptor, in healthy adult volunteers. The clinical trial was designed to support the advancement of clinical development for TX2100 as a potential treatment for Hereditary Hemorrhagic Telangiectasia (HHT), a rare, inherited vascular disorder with no currently approved therapies. The Company also announced that the U.S. Food and Drug Administration (FDA) granted TX2100 Fast Track Designation for HHT. In addition, the FDA recently cleared the Company’s Investigational New Drug (IND) application to conduct the upcoming TX2100 Phase 1b clinical trial in the U.S. in patients with HHT.

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