M254 / J&J - LARVOL DELTA

Hyper-Sialylated IgG M254, an Innovative Therapeutic Candidate, Evaluated in Healthy Volunteers and in Patients with Immune Thrombocytopenia Purpura: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics (ASH 2019) - P1/2; "The protocol allowed for a seamless transition from evaluating M254 in healthy volunteers to patients with ITP. We have now initiated Part B of the study."

Clinical • PK/PD data

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients (clinicaltrials.gov) - P1/2; N=50; Terminated; Sponsor: Momenta Pharmaceuticals, Inc.; Trial completion date: Jun 2022 ➔ Jun 2021; Recruiting ➔ Terminated; Trial primary completion date: Apr 2022 ➔ Jun 2021; Study was terminated based on Sponsor decision.

Clinical • Trial completion date • Trial primary completion date • Trial termination • Hematological Disorders • Thrombocytopenic Purpura

[VIRTUAL] α-MSH induces melanogenesis via up-regulation of Opsin1 in cultured human skin melanocytes in vitro (SID 2020) - " Melanocytes were obtained from human foreskin with two-step enzyme-digestion and then cultured in M254 medium supplied with human melanocyte growth supplement for three passages... α-MSH up-regulates Opsin1 and enhances melanogenesis in cultured human epidermal skin melanocytes in vitro."

Preclinical • MITF

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: Momenta Pharmaceuticals, Inc.; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Apr 2020 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Thrombocytopenic Purpura

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: Momenta Pharmaceuticals, Inc.; Trial completion date: Oct 2020 ➔ Jun 2021; Trial primary completion date: Dec 2019 ➔ Apr 2020

Clinical • Trial completion date • Trial primary completion date

Melanocytes retained in the skin lesion of vitiligo with resistant to narrow-band ultraviolet B phototherapy and lazy to grow in the culture in vitro (SID 2019) - "1. Epidermal melanocyte were successfully isolated from depigmented epidermal suction blister tissue of 12 cases of vitiligo resistant to narrow-band ultraviolet B phototherapy. However, melanocytes can not be passaged in the M254 culture condition in vitro."

Preclinical

Opsin as a photoreceptor after UVA irradiation to regulate MITF signal pathway and influence melanogenesis in the cultured human melanocyte (SID 2019) - "... Suspended human melanocytes were obtained from human foreskin with two-step enzyme-digestion method and then cultured in M254 medium supplied with human melanocyte growth supplement and for three passages... After irradiation of melanocytes with UVA, the Opsin may regulate the MITF signal pathway to affect the production of melanin."

Preclinical

Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients (clinicaltrials.gov) - P1/2; N=70; Recruiting; Sponsor: Momenta Pharmaceuticals, Inc.

Clinical • New P1/2 trial

Safety and tolerability of M254 in healthy volunteers and immune thrombocytopenic purpura (ITP) patients (clinicaltrialsregister.eu) - P1/2; N=70; Ongoing; Sponsor: Momenta Pharmaceuticals, Inc.

Clinical • New P1/2 trial