MK-2225 / Merck (MSD) - LARVOL DELTA

A Study of MK-2225 in Healthy Participants (MK-2225-003) (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed

Trial completion • Immunology • Scleroderma • Systemic Sclerosis

A Study of MK-2225 in Healthy Participants (MK-2225-003) (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Jul 2025 | Trial primary completion date: Oct 2025 ➔ Jul 2025

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

A Study of MK-2225 in Healthy Participants (MK-2225-003) (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=24 ➔ 32

Enrollment change • Immunology • Scleroderma • Systemic Sclerosis

A Study of MK-2225 in Healthy Participants (MK-2225-003) (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting | Trial completion date: Feb 2025 ➔ Oct 2025 | Trial primary completion date: Feb 2025 ➔ Oct 2025

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

A Study of MK-2225 in Healthy Participants (MK-2225-003) (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Immunology • Scleroderma • Systemic Sclerosis

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1 | N=5 | Terminated | Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Phase classification: P1b ➔ P1 | N=48 ➔ 5 | Trial completion date: Jun 2027 ➔ Oct 2023 | Active, not recruiting ➔ Terminated; Business Reasons

Enrollment change • Phase classification • Trial completion date • Trial termination • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1b | N=48 | Active, not recruiting | Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

TGFβ2 UPREGULATION ON REACTIVE CHOLANGIOCYTES LIMITS THE THERAPEUTIC EFFICACY OF TGFβ TRAP RAP-1332 IN MOUSE MODELS OF CHRONIC BILIARY INJURY AND FIBROSIS (AASLD 2023) - "Background: RAP-1332 (murine ortholog of ACE-1334), is a new recombinant Fc fusion protein that functions as a ligand trap for TGFβ1 and TGFβ3 isoforms, but spares TGFβ2... RAP-1332 (1, 3 and 10 mg/kg twice a week) or ALK5 inhibitor (SB-525334, 30 mg/kg/day) was tested in clinically relevant mouse model of PSC-like mouse models of pre-established biliary fibrosis (BALBc.Mdr2-/-, n=6-12/group) starting at 4 weeks (early therapy) or 6 weeks (delayed therapy) of age for the following 4-6 weeks, respectively... Our results suggest that selective blocking TGFβ1 and TGFβ3 in chronic biliary fibrosing disease is inefficient due to compensatory upregulation of TGFβ2 on reactive cholangiocytes. This non-dispensable pathological role of TGFβ2 should be accounted for in future design of TGFβ traps and therapeutic TGFβ targeting."

Preclinical • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Liver Failure • ABCB4 • CD68 • PTPRC • TGFB1 • TGFB2 • TGFBR1

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1b | N=48 | Recruiting | Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | Trial completion date: Aug 2026 ➔ Jun 2027 | Trial primary completion date: Aug 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1b | N=48 | Recruiting | Sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | Trial completion date: Apr 2026 ➔ Aug 2026 | Trial primary completion date: Apr 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study of MK-2225 (ACE-1334) in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1b | N=48 | Recruiting | Sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | Not yet recruiting ➔ Recruiting | Trial completion date: May 2028 ➔ Apr 2026 | Trial primary completion date: Dec 2027 ➔ Apr 2026

Enrollment open • Trial completion date • Trial primary completion date • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

A Study of MK-2225 (ACE-1334) in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) (clinicaltrials.gov) - P1b | N=48 | Not yet recruiting | Sponsor: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | Phase classification: P1b/2 ➔ P1b | N=210 ➔ 48

Enrollment change • Phase classification • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Phase 1B Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Ace-1334 On Top Of Standard Of Care In Systemic Sclerosis With And Without Interstitial Lung Disease (SSWC 2022) - No abstract available

Clinical • P1 data • PK/PD data • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Study of ACE-1334 to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (clinicaltrials.gov) - P1b/2 | N=210 | Active, not recruiting | Sponsor: Acceleron Pharma Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CRP

Study of ACE-1334 to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic Effects, and Efficacy in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (clinicaltrials.gov) - P1b/2; N=210; Recruiting; Sponsor: Acceleron Pharma Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CRP

"ace 1334 has absolutely nothing to do with oncology. might want to do more research." (@Scorpionblue13)

Oncology

"Here's a crazy thought: what if $MRK combines Keytruda with ACE-1334 for oncology use? $XLRN" (@JacobPlieth)

Oncology

Merck to Acquire Acceleron Pharma Inc. (Businesswire) - “Merck…and Acceleron Pharma Inc…announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Acceleron for $180 per share in cash for an approximate total equity value of $11.5 billion….Acceleron has expanded its rare pulmonary disease pipeline and is investigating the potential of ACE-1334 in a Phase 1b/Phase 2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD).”

M&A • Interstitial Lung Disease • Systemic Sclerosis

Acceleron Reports Second Quarter 2021 Financial Results (Businesswire) - "ACE-1334: Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)...Acceleron expects to start a Phase 1b/Phase 2 study to evaluate the activity of ACE-1334 in patients with SSc-ILD by year-end 2021."

New P1/2 trial • Interstitial Lung Disease • Systemic Sclerosis