HMI-115 / Bayer, Hope Medicine - LARVOL DELTA

Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Endometriosis • Gynecology • Pain • Women's Health

Emerging pharmacotherapies for Androgenetic Alopecia. (PubMed, Expert Opin Pharmacother) - "These include topical androgen-receptor antagonists and degraders (clascoterone, GT20029), biologics targeting prolactin receptor inhibition (HMI-115, ABS-201), anagen-inducing injectables (AMP-303), metabolic and follicular activators (PP405, ET-02), thyroid hormone receptor-β agonists (KB-141), optimized potassium channel opener delivery systems (extended-release and sublingual minoxidil) and modulation of longevity pathways using rapamycin and metformin. Collectively, these newer pharmacotherapeutics aim to improve efficacy, safety, and patient adherence. Ongoing and future clinical trials will determine their definitive role in reshaping the therapeutic landscape of androgenetic alopecia."

Journal • Review • Alopecia • Immunology

Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd

New P3 trial • Endometriosis • Gynecology • Pain • Women's Health

Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development (PRNewswire) - "The granting of Fast Track Designation was based on the results of a completed global Phase II clinical trial for HMI-115....The granting of Fast Track Designation was based on the results of a completed global Phase II clinical trial for HMI-115."

Fast track • Endometriosis

A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain (clinicaltrials.gov) - P2 | N=142 | Completed | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Pain • Women's Health

Single-cell RNA sequencing identifies the prolactin receptor as a therapeutic target in adenomyosis. (PubMed, Signal Transduct Target Ther) - "Importantly, we demonstrated that dysregulation of local PRL signaling led to the development and progression of adenomyosis, whereas inhibition of PRLR with the monoclonal antibody HMI-115 markedly ameliorated pathological manifestations. These findings establish PRL signaling as a critical driver of adenomyosis pathogenesis, highlighting PRLR inhibition as a promising therapeutic strategy and demonstrating the translational potential of HMI-115 for treating adenomyosis, a gynecological condition that has long been neglected in drug development."

Journal • Endometriosis • Gynecology • Inflammation • Transplantation • Women's Health • PRL • PRLR

Efficacy and Safety Study of a Prolactin Receptor-Targeted Monoclonal Antibody for the Treatment of Female Migraine: A Single-Center Exploratory Clinical Trial (ChiCTR) - P=N/A | N=10 | Not yet recruiting | Sponsor: West China Hospital, Sichuan University; West China Hospital of Sichuan University

New trial • CNS Disorders • Migraine • Pain

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=192 | Completed | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Recruiting ➔ Completed | Trial primary completion date: Dec 2024 ➔ Aug 2024

Trial completion • Trial primary completion date • Alopecia • Dermatology • Immunology

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects with Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial primary completion date • Alopecia • Dermatology • Immunology

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial primary completion date • Alopecia • Dermatology • Immunology

An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period (ANZCTR) - P1 | N=20 | Completed | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Immunology

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd

New P2 trial • Alopecia • Immunology

Chime Biologics and Hope Medicine Enter Manufacturing Agreement to Speed up the Launch of First-in-class Antibody Drug HMI-115 Targeting Endometriosis and Androgenic Alopecia (BioSpace) - "Chime Biologics...and Hope Medicine Inc...announced on September 28 that the companies are collaborating to develop and manufacture the first-in-class monoclonal antibody drug HMI-115. Under the terms of the agreement, Chime Biologics will provide one-stop-shop CMC solution for Hope Medicine's HMI-115 monoclonal antibody from technology transfer, process optimization, scale-up, clinical phase III GMP production, process characterization, process validation, BLA filing support, to commercial manufacturing. Hope Medicine will leverage Chime Biologics' extensive experience in 2000L cGMP manufacturing, late-stage CMC development and BLA filings to jointly accelerate HMI-115 mAb development and manufacturing for speedy clinical advancement of targeting endometriosis and androgenetic alopecia, benefiting more female patients and alopecia patients."

Licensing / partnership • Alopecia • Dermatology • Endometriosis • Women's Health

To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Oct 2023

Trial completion • Trial completion date • Alopecia • Immunology

A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Trial completion date: Sep 2023 ➔ Apr 2025 | Trial primary completion date: Mar 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Pain • Women's Health

To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Alopecia

To Evaluate the Safety, Tolerability and Efficacy in Male and Female With AGA Treated With HMI-115 Over a 24-week Treatment Period (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd

New P1 trial • Alopecia

A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Hope Medicine (Nanjing) Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Endometriosis • Gynecology • Pain