LASN01 / Lassen Therap, Cedars-Sinai - LARVOL DELTA

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Lassen Therapeutics Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Apr 2025

Trial completion • Trial completion date • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: Lassen Therapeutics Inc. | Trial completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease (clinicaltrials.gov) - P1/2 | N=75 | Completed | Sponsor: Lassen Therapeutics 1 PTY LTD | Active, not recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Thyroid Eye Disease

LASN01 is a novel, clinical stage antibody that blocks inflammatory cytokine and chemokine release in in vitro studies using orbital fibroblasts from thyroid eye disease (TED) patients (ATA 2024) - "This data suggests IL-11 may be an important factor in the in flammation-mediated orbital tissue remodeling in TED and that IL-11 may be upstream of IL-6 release by orbital fibro-blasts. The ability of LASN01 to block the release of multiple cytokines, whereas teprotumumab did not, indicates that LASN01 may provide a unique and differentiated treatment for TED that is not addressed by IGF-1 receptor blockade alone."

Preclinical • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease • CCL2 • CXCL8 • IGF1 • IL6

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: Lassen Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease (clinicaltrials.gov) - P1/2 | N=75 | Active, not recruiting | Sponsor: Lassen Therapeutics 1 PTY LTD | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Feb 2025 | Trial primary completion date: Sep 2025 ➔ Feb 2025

Enrollment closed • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Thyroid Eye Disease

Phase 1 Healthy Volunteer Data Supports Phase 2 Study of LASN01 in Thyroid Eye Disease (TED) – Actively Enrolling (AACE 2024) - "Orbital MRIs will be collected to assess proptosis and extraocular muscles. LASN01 is the only agent being developed for TED which offers the possibility of addressing the fibro-inflammatory pathology of TED."

Clinical • P1 data • P2 data • Endocrine Disorders • Grave’s Disease • Inflammation • Ocular Inflammation • Ophthalmology • Pain • Thyroid Eye Disease • IGF1 • TGFB1

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Lassen Therapeutics Inc. | Trial completion date: Mar 2025 ➔ Sep 2025

Trial completion date • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

Phase 1 Healthy Volunteer Data Supports Phase 2 Study of LASN01 in Thyroid Eye Disease (TED) - Actively Enrolling (ENDO 2024) - "Abstract is embargoed at this time."

Clinical • P1 data • P2 data • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Lassen Therapeutics 1 PTY LTD | Phase classification: P1 ➔ P1/2 | Trial completion date: Sep 2024 ➔ Sep 2025 | Trial primary completion date: Sep 2024 ➔ Sep 2025

Phase classification • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Thyroid Eye Disease

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Lassen Therapeutics Inc. | N=24 ➔ 36

Enrollment change • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Lassen Therapeutics Inc.

New P2 trial • Endocrine Disorders • Ophthalmology • Thyroid Eye Disease

Lassen Therapeutics Announces Closing of Oversubscribed $85 Million Series B Financing and Announces First Patient Dosed in the Phase 1 Trial Evaluating LASN01 in Thyroid Eye Disease (BioSpace) - "Lassen Therapeutics...announced the closing of an oversubscribed Series B financing which raised $85 million. Frazier Life Sciences co-led the financing along with new investor Longitude Capital. The syndicate also included new investors BVF Partners and Catalio Capital Management as well as existing investors, Alta Partners and Longwood Capital. Concurrent with this financing, Brian Liu, M.D. from Longitude Capital and Matthew Hobson, Ph.D. from Catalio Capital Management have joined the Board of Directors. Proceeds from this financing will support the LASN01 clinical program and advance IND-enabling activities for LASN500. The clinical program for LASN01 is focused primarily in TED with a cohort in IPF in the Phase 1 program."

Financing • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Thyroid Eye Disease

Lassen Therapeutics Presents Preclinical Data on LASN01, an Anti-IL-11 Receptor Antibody in Development for Treatment of Thyroid Eye Disease at the American Thyroid Association 2023 Annual Meeting (Businesswire) - "Lassen Therapeutics...presented new preclinical data on LASN01, for treatment of TED, at the American Thyroid Association (ATA) Annual Meeting held in Washington DC, September 27 through October 1, 2023....A poster...described how LASN01 inhibits hyaluronic acid (HA) release, proliferation, and procollagen production in response to IL-11, the combination of IL-11 and IGF-1, or TGFβ in orbital fibroblasts (OF) from TED patients following orbital decompression surgery. The effects of LASN01 on HA release and OF proliferation were comparable to the approved anti-IGF-1R antibody, teprotumumab, indicating that LASN01 should be further investigated as a potential new therapeutic agent for the treatment of TED."

Preclinical • Immunology • Thyroid Eye Disease

LASN01, A HIGH AFFINITY ANTI‐INTERLEUKIN‐11 RECEPTOR ANTIBODY, BLOCKS PATHOLOGICAL MECHANISMS OF THYROID EYE DISEASE LINKED TO CLINICAL EFFICACY (ATA 2023) - "IL-11 is implicated in the pathogenesis of TED, possibly downstream of other known stimuli relevant to TED biology. LASN01 is a potent inhibitor of IL-11 signaling, leading to the suppression of cell proliferation and HA secretion from TED OF, while also demonstrating anti-fibrotic activity. For this reason, LASN01 is worthy of further investigation as a potential new therapeutic agent for the treatment of TED."

Clinical • Fibrosis • Immunology • Ophthalmology • Thyroid Eye Disease • IGF1

Lassen Therapeutics Presents New Data on LASN01 for the Treatment of Idiopathic Pulmonary Fibrosis and Thyroid Eye Disease at the European Respiratory Society (ERS) and European Thyroid Association (ETA) Annual Meetings (Businesswire) - P1 | N=80 | NCT05331300 | Sponsor: Lassen Therapeutics 1 PTY LTD | "Lassen Therapeutics...today announced new clinical and preclinical data generated with LASN01 at the 2023 European Respiratory Society (ERS) International Congress and the 45th Annual Meeting of the European Thyroid Association (ETA)....A presentation...described Phase 1 data showing that LASN01 was well tolerated in healthy volunteers, has dose linear pharmacokinetics (PK), and resulted in dose-dependent suppression of STAT3 phosphorylation. pSTAT3 inhibition was greater than 95% at day 70 with two doses each at 600 and 1200 mg. PK data support monthly dosing with a half-life of approximately 11 days at the 1200 mg dose....LASN01 also showed a significant antifibrotic effect in a humanized mouse model of IPF lung fibrosis, reducing collagen deposition by >80%."

P1 data • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease

A Novel Interleukin-11 Receptor Antibody, LASN01 Is Well Tolerated and Demonstrates Target Engagement in Phase 1 (ERS 2023) - "A proprietary assay using ex-vivo stimulated whole blood showed >95% inhibition of IL-11R signaling by LASN01 with a single 300 mg dose or 600 mg dose that persisted for 4 and 8 weeks respectively. LASN01 is well tolerated, and robustly inhibits the IL-11 pathway in human volunteers.; Physiology; Cell and molecular biology; General respiratory patient care"

P1 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pain • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Lassen Therapeutics 1 PTY LTD | Trial completion date: Dec 2023 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Ophthalmology • Pulmonary Disease • Respiratory Diseases • Thyroid Eye Disease

A First-in-Class IL-11 Receptor Blocking Antibody as a Treatment for Pulmonary Fibrosis (ATS 2023) - "These data further demonstrate the potent anti-fibrotic effects of IL-11Rα blockade and support the continued clinical advancement of LASN01, a human anti-IL-11Rα as a first-in-class treatment for IPF, other forms of interstitial lung disease, and potentially additional immune-fibrotic diseases."

Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • CXCL8 • TIMP1

Lassen Therapeutics Presents Phase I Data on LASN01, an IL-11 Receptor-Blocking Antibody for Treatment of Pulmonary Fibrosis, at the American Thoracic Society 2023 Annual Meeting (Businesswire) - "Lassen Therapeutics...resented new preclinical and Phase I data of LASN01 for treatment of pulmonary fibrosis, at today’s American Thoracic Society (ATS) Annual Meeting being held in Washington DC....'We are pleased to present preclinical efficacy across multiple organs paired with clinical data demonstrating dose linear pharmacokinetics in the Phase 1 clinical study in healthy volunteers. These data, in addition to safety and target engagement of LASN01, enables investigation of LASN01 in multiple indications in the Phase 2 program including thyroid eye disease.'"

P1 data • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Lassen Therapeutics Announces Oral Presentation of Phase I Data of LASN01, an IL-11 Receptor-Blocking Antibody for Treatment of Pulmonary Fibrosis, at the American Thoracic Society 2023 Annual Meeting (Businesswire) - P1 | N=64 | NCT05331300 | Sponsor: Lassen Therapeutics 1 PTY LTD | "Lassen Therapeutics...will present new preclinical and Phase I data of LASN01...at the American Thoracic Society (ATS) Annual Meeting being held in Washington DC, May 19-24, 2023. In addition to the oral presentation at the Annual Meeting, Lassen has been invited to present at the ATS Respiratory Innovation Summit taking place on May 19, 2023....The presentation at ATS will further provide data demonstrating the fibro-inflammatory role of IL-11 in the lung and other tissues, and includes clinical pharmacokinetic and pharmacodynamic data for LASN01. In the Phase I study, LASN01 exhibited dose-linear pharmacokinetics, with an excellent safety profile in healthy volunteers. Dose-dependent inhibition of receptor signaling was demonstrated in a blood-based assay, demonstrating potent activity of the circulating antibody."

P1 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Lassen Therapeutics 1 PTY LTD | Trial completion date: May 2024 ➔ Dec 2023 | Trial primary completion date: May 2024 ➔ Dec 2023

Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Lassen Therapeutics Commences Dosing in Phase 1 Clinical Study of LASN01, a First-in-Class Interleukin-11 Receptor-Blocking Antibody (Businesswire) - "Lassen Therapeutics...announced the initiation of dosing in a Phase 1 study of LASN01, a novel interleukin-11 (IL-11) receptor-blocking antibody. The Phase 1 single and multiple ascending dose study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of LASN01 in healthy volunteers....'The initiation of this trial is an important milestone for Lassen and continues our progress towards developing a new treatment option for patients with excessive fibrosis'....The initiation of this Phase 1 trial and the LASN01 clinical program is based in part on pre-clinical data reported at the American Thoracic Society (ATS) Annual Meeting 2022."

Trial status • Fibrosis • Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Safety and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Lassen Therapeutics 1, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Characterization of a Novel IL-11 Receptor-Blocking Antibody, a Potential Therapeutic for IPF and Other Fibrosing Lung Diseases (ATS 2022) - "RATIONALE: Interleukin 11 (IL-11) is a pleiotropic cytokine that is reported to be an important regulator of fibroblast activation and tissue fibrosis. Combined, these data indicate that IL-11 is a prominent fibroinflammatory mediator in the lung and IL-11RA blockade may provide a novel therapeutic approach to treat grievous diseases such as IPF or other fibrosing ILD’s."

Fibrosis • Idiopathic Pulmonary Fibrosis • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL6 • STAT3 • TGFB1