Tectonic Therapeutic Announces Positive Phase 1a Results in AHA 2024 Presentation for TX45, a Long-acting, Fc-Relaxin Fusion Protein

In This Article:

Tectonic Therapeutic
Tectonic Therapeutic
  • Phase 1a results support further development of TX000045 (“TX45”) for Group 2 Pulmonary Hypertension in HFpEF (“PH-HFpEF”), based on favorable pharmacokinetic profile and impact on renal plasma flow (“RPF”)

  • TX45 showed a favorable safety profile, with no observed injection site reactions, immunogenicity, or detection of anti-drug antibodies

  • RPF-based exposure-response model enabled APEX Phase 2 dose selection

  • Upcoming topline results from the ongoing TX45 clinical program includes Phase 1b hemodynamic, proof-of-concept trial data expected in late 1Q or early 2Q’2025, and APEX Phase 2 clinical trial data expected in 2026

WATERTOWN, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic”) 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 detailed results from the Phase 1a clinical trial of its lead asset, TX45, a long-acting, Fc-relaxin fusion protein. The poster will be presented at the American Heart Association (AHA) Scientific Sessions on November 16, 2024 from 3-4pm EST in Chicago, Illinois. Favorable topline results from the TX45 Phase 1a clinical trial were announced on September 19, 2024, along with the dose selection for the TX45 APEX Phase 2 trial that is currently underway in patients with PH-HFpEF.

“Favorable Phase 1a results allowed us to confidently move ahead with our APEX Phase 2 clinical trial. We continue to be very enthusiastic about advancing TX45 as a potential best-in-class, long-acting relaxin therapeutic for patients with PH-HFpEF,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. “Both of our ongoing clinical studies in patients with PH-HFpEF remain on track with topline results from our Phase 1b hemodynamic trial expected in late 1Q’2025 or early 2Q’2025, followed by topline results from our APEX Phase 2, 24-week clinical trial anticipated in 2026.”

The Phase 1a single ascending dose (“SAD”) clinical trial assessed the safety and tolerability of TX45 in 55 healthy volunteers. Additionally, the Phase 1a clinical trial evaluated pharmacokinetic (“PK”) and pharmacodynamic (“PD”) measures of TX45 based on relaxin’s known ability to increase RPF in order to create an exposure-response model for Phase 2 dose selection.

Phase 1a Highlights:

Safety Results: TX45 was well tolerated with no drug-related severe adverse events, no evidence of immune-mediated clearance, and no antidrug antibodies or injection site reactions.

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