TX45 / Tectonic Therap - LARVOL DELTA

Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Tectonic Operating Company, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026 ➔ Aug 2026

Enrollment open • Trial initiation date • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) (clinicaltrials.gov) - P2 | N=191 | Active, not recruiting | Sponsor: Tectonic Therapeutic | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TX000045-003: A 24-Week Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF) (the APEX Study) (clinicaltrialsregister.eu) - P1/2 | N=201 | Active, not recruiting | Sponsor: Tectonic Therapeutic Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Development of a long-acting relaxin for the treatment of pulmonary hypertension. (PubMed, Br J Pharmacol) - "TX45 is an extended half-life relaxin with PK and PD properties consistent with a relaxin mimetic. TX45 was well tolerated in early clinical studies. Preclinical PK/PD data predicted human PK/PD."

First-in-human • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Tectonic Operating Company, Inc.

New P2 trial • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TX000045-003: A 24-Week Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF) (the APEX Study) (clinicaltrialsregister.eu) - P1/2 | N=181 | Recruiting | Sponsor: Tectonic Therapeutic Inc.

New P1/2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Tectonic Therapeutic to Present Phase 1b Data for TX45 at European Society of Cardiology Heart Failure 2025 (GlobeNewswire) - "Tectonic Therapeutic, Inc...today announced that it will make a late-breaking oral presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress. The presentation will highlight Phase 1b data for TX45...for patients with Group 2 PH-HFpEF. The presentation at ESC Heart Failure 2025 will include the full Phase 1b PH-HFpEF cohort results for TX45, expanding on the interim data previously announced by Tectonic on January 30, 2025."

Late-breaking abstract • P1 data • Cardiovascular • Heart Failure • Pulmonary Arterial Hypertension

Tx000045 (TX45), A Novel Fc-Relaxin-2 Fusion Protein: Bioengineering and Preclinical Development for the Treatment of Group 2 PH (ISHLT 2025) - "TX45 also significantly improved pulmonary hemodynamics in MCT-induced PH in rats. Collectively our preclinical data supports clinical testing of TX45, in patients with Group 2 PH."

Preclinical • Cardiovascular • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Tectonic Announces $185 Million Private Placement (GlobeNewswire) - "Tectonic Therapeutic, Inc...today announced that it has entered into a securities purchase agreement for a private investment in public equity financing (the 'PIPE') that is expected to result in gross proceeds of approximately $185.0 million...Tectonic expects to use net proceeds from the PIPE to fund the clinical development of TX45, clinical development of TX2100, discovery platform development as well as for working capital and other general corporate purposes. The PIPE is expected to close on February 5, 2025, subject to the satisfaction of customary closing conditions."

Financing • Cardiovascular • Respiratory Diseases

The tolerability, safety, pharmacokinetics, and pharmacodynamics of TX000045, a long-acting Fc-relaxin fusion protein after single doses in healthy volunteers (AHA 2024) - "TX45 was generally well tolerated with a safety, pharmacokinetic and pharmacodynamic profile to support further clinical development. Its maximum effect on RPF is similar to previously described effects of native relaxin. Its half-life will support a prolonged dosing interval."

Clinical • PK/PD data • Congestive Heart Failure • Heart Failure • Hypotension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A single -ascending dose study of TX000045 in healthy participants (ANZCTR) - P1 | N=75 | Completed | Sponsor: Tectonic Therapeutic | Recruiting ➔ Completed | N=48 ➔ 75

Enrollment change • Trial completion • Cardiovascular

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Tectonic Therapeutic

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Tectonic Therapeutic Announces US IND Clearance for Lead Program, TX45 (GlobeNewswire) - "Tectonic Therapeutic...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TX45, an Fc-relaxin fusion protein being evaluated for the treatment of patients with Group 2 PH-HFpEF.....Tectonic expects to initiate the global Phase 2 clinical trial of TX45 in PH-HFpEF in the third quarter of 2024, with topline results anticipated in 2026. The trial is designed to evaluate efficacy in the broad PH-HFpEF population and enrich for the subset of Group 2 PH patients with a more severe form of disease known as combined post and precapillary pulmonary hypertension (CpcPH) defined by baseline pulmonary vascular resistance (PVR) of greater than 3 Wood units. The trial plans to enroll up to 180 subjects who will be randomized to one of two dose regimens of TX45 or placebo."

IND • New P2 trial • Respiratory Diseases

To evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TX000045 (single ascending dose) in Healthy Volunteers (ANZCTR) - P1 | N=48 | Recruiting | Sponsor: Tectonic Therapeutic | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Cardiovascular