teprotumumab subcutaneous / Amgen, Xeris Biopharma - LARVOL DELTA

Pharma powerhouse Amgen has reported that TEPEZZA (teprotumumab-trbw) delivered via a subcutaneous on-body injector (OBI) achieved positive topline results in a Phase 3 trial for patients with moderate-to-severe active Thyroid Eye Disease (TED) (Indian Pharma Post) - "The results show that TEPEZZA OBI matches the efficacy of intravenous (IV) TEPEZZA, which has already treated more than 25,000 patients worldwide. The trial met its primary endpoint, with a 77% proptosis response rate during the 24-week placebo-controlled period. Key secondary endpoints were also met, including a mean proptosis reduction of -3.17 mm at week 24....The trial also demonstrated significant improvements across multiple secondary endpoints, including overall responder rate, Clinical Activity Score (CAS), diplopia measures, and the Graves' Ophthalmopathy Quality of Life (GO-QoL) appearance subscale."

P3 data • Immunology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=89 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Amgen | Trial completion date: May 2026 ➔ Sep 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Amgen | Trial completion date: Sep 2025 ➔ May 2026

Trial completion date • Ophthalmology • Thyroid Eye Disease

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Amgen

New P1 trial

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Amgen | Trial completion date: Mar 2026 ➔ Sep 2025

Trial completion date • Ophthalmology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Horizon Pharma USA, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

HZNP-TEP-305: A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=80 | Not yet recruiting | Sponsor: Horizon Pharma USA, Inc.

New P3 trial • Ophthalmology • Thyroid Eye Disease

Xeris Biopharma Enters Into an Exclusive Worldwide License Agreement for Xeriject Formulation of Teprotumumab (Businesswire) - "Xeris Biopharma Holdings, Inc...today announced that it has entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris’ XeriJect^® technology in Thyroid Eye Disease (TED) - a serious, progressive and potentially vision-threatening rare autoimmune disease....Under the terms of the License Agreement, Xeris has the potential to receive $75 million in development and regulatory milestones, plus sales-based milestones, as well as escalating single-digit royalties based on future sales of TEPEZZA using the XeriJect technology."

Licensing / partnership • Immunology • Thyroid Eye Disease

Horizon Therapeutics plc Reports Record Second-Quarter 2021 Financial Results; Increasing Full-Year 2021 Net Sales and Adjusted EBITDA Guidance (Businesswire) - "TEPEZZA...Subcutaneous (SC) Administration: Phase 1 pharmacokinetic trial underway to explore SC administration of TEPEZZA...Diffuse Cutaneous Systemic Sclerosis Exploratory Trial: Phase 1 exploratory trial to evaluate TEPEZZA in dcSSc expected to initiate in the third quarter of 2021...Diffuse Cutaneous Systemic Sclerosis Trial: Pivotal Phase 2b trial to evaluate HZN-825 in diffuse cutaneous systemic sclerosis expected to initiate in the third quarter of 2021...Pivotal Phase 2b trial to evaluate HZN-825 in idiopathic pulmonary fibrosis...expected to initiate in the third quarter of 2021."

New P1 trial • New P2b trial • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Respiratory Diseases • Systemic Sclerosis