INCB000547 / Incyte - LARVOL DELTA

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=62 | Completed | Sponsor: Escient Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Incyte Completes Acquisition of Escient Pharmaceuticals (Businesswire) - "Incyte...today announced that it has completed its acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders....Through this transaction, Incyte has added EP262 and EP547 to its portfolio."

M&A • Atopic Dermatitis • Chronic Spontaneous Urticaria • Immunology • Pruritus • Urticaria

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: Escient Pharmaceuticals, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Incyte Announces Acquisition of Escient Pharmaceuticals and its Pipeline of First-in-Class Oral MRGPR Antagonists (Businesswire) - "Incyte...and Escient Pharmaceuticals...have entered into a definitive agreement under which Incyte has agreed to acquire Escient, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist....By blocking MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell-mediated diseases including atopic dermatitis (AD), chronic inducible urticaria (CIndU) and chronic spontaneous urticaria (CSU)....EP547 is a first-in-class oral MRGPRX4 antagonist with the potential to treat cholestatic pruritus and other conditions with severe pruritus....Under the terms of the agreement, Incyte will acquire Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments."

M&A • Atopic Dermatitis • Chronic Spontaneous Urticaria • Pruritus • Urticaria

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc

Trial completion date • Trial primary completion date • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc | Trial completion date: Feb 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=58 | Recruiting | Sponsor: Escient Pharmaceuticals, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

PACIFIC: Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (clinicaltrials.gov) - P2 | N=58 | Not yet recruiting | Sponsor: Escient Pharmaceuticals, Inc

New P2 trial • Dermatology • Hepatology • Immunology • Primary Biliary Cholangitis • Pruritus

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (clinicaltrials.gov) - P1 | N=89 | Completed | Sponsor: Escient Pharmaceuticals, Inc | Active, not recruiting ➔ Completed

Trial completion • Cholestasis • Chronic Kidney Disease • Dermatology • Hepatology • Pruritus • Renal Disease

[VIRTUAL] FIRST-IN-HUMAN STUDY OF EP547, A POTENT AND HIGHLY SELECTIVE MRGPRX4 INVERSE AGONIST IN DEVELOPMENT FOR TREATMENT OF CHOLESTATIC PRURITUS (AASLD 2021) - "EP547 is well tolerated in healthy subjects and patients with cholestatic liver disease, with no adverse safety trends identified. The plasma PK of EP547 is consistent with predictions from nonclinical studies, shows strong dose linearity, and supports once-daily administration . These results support advancement of EP547 into Phase 2 development in patients with cholestatic pruritus ."

P1 data • Dermatology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Primary Biliary Cholangitis • Pruritus

[VIRTUAL] DEVELOPMENT OF EP547: A POTENT, HIGHLY SELECTIVE MRGPRX4 INVERSE AGONIST FOR THE TREATMENT OF CHOLESTATIC AND UREMIC PRURITIS (AASLD 2021) - "Collectively, these studies demonstrate that EP547 is a novel, potent and selective inverse agonist at the human MRGPRX4 receptor that blocks the activity of multiple bile components and putative pruritogens . EP547 is currently in clinical development as a potential once-daily oral treatment for both cholestatic and uremic pruritus ."

Dermatology • Pruritus • Renal Disease

Escient Pharmaceuticals Announces Positive Results from Phase 1 Study of EP547, an MrgprX4-Targeted Oral Therapy for Cholestatic and Uremic Pruritus (Businesswire) - P1, N=89; NCT04510090; Sponsor: Escient Pharmaceuticals, Inc; "Escient Pharmaceuticals...announced positive results from a Phase 1 study of EP547, a new chemical entity and potent MrgprX4 antagonist, being developed for the treatment of pruritus associated with cholestasis and uremia. The study found that EP547 was safe and well-tolerated in both healthy volunteers and patients with chronic cholestatic or kidney disease at all doses tested."

P1 data • Dermatology • Pruritus

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (clinicaltrials.gov) - P1; N=89; Active, not recruiting; Sponsor: Escient Pharmaceuticals, Inc; Recruiting ➔ Active, not recruiting; N=128 ➔ 89

Clinical • Enrollment change • Enrollment closed • Cholestasis • Chronic Kidney Disease • Dermatology • Hepatology • Pruritus • Renal Disease

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (clinicaltrials.gov) - P1; N=116; Recruiting; Sponsor: Escient Pharmaceuticals, Inc; Trial completion date: Feb 2021 ➔ Jun 2021; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Cholestasis • Chronic Kidney Disease • Dermatology • Hepatology • Pruritus • Renal Disease

Sanofi backs Escient's $77.5M round as it kick-starts first clinical test (FierceBiotech) - "Escient Pharmaceuticals has grabbed a meaty $77.5 million series B with the help of Sanofi’s VC arm as the biotech also starts its first in-human tests....Now, it’s second funding round has nearly doubled from its first, giving it the cash to start a phase 1 for its leading drug EP547, a MRGPRX4-targeted product candidate to treat cholestatic and uremic pruritus, a form of severe itching resulting from liver or kidney disease."

Financing • Pruritus

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (clinicaltrials.gov) - P1; N=116; Recruiting; Sponsor: Escient Pharmaceuticals, Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cholestasis • Chronic Kidney Disease • Dermatology • Hepatology • Pruritus • Renal Disease

Escient Pharmaceuticals Raises $77.5 Million Series B Round and Initiates a Phase 1/1b Clinical Trial of EP547, a MRGPR-targeted Therapy to Treat Cholestatic and Uremic Pruritus (Businesswire) - "Escient Pharmaceuticals...today announced the completion of a $77.5 million Series B financing and the initiation of a Phase 1/1b clinical trial of EP547...to treat cholestatic and uremic pruritus. The round was led by Sanofi Ventures and Cowen Healthcare Investments (CHI) with participation by new investors Redmile Group and Perceptive Advisors."

Financing • Pruritus

Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus (clinicaltrials.gov) - P1; N=116; Not yet recruiting; Sponsor: Escient Pharmaceuticals, Inc

Clinical • New P1 trial • Cholestasis • Chronic Kidney Disease • Dermatology • Hepatology • Pruritus • Renal Disease