HMI-115 / Bayer, Hope Medicine - LARVOL DELTA

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