PN-101 / Paean Bio - LARVOL DELTA

Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Paean Biotechnology Inc.

New P2 trial • Dermatomyositis • Immunology • Myositis

Paean Bio, polymyositis new drug substance 'PN-101' domestic phase 2 approval [Google translation] - "Paean Biotechnology...announced on the 11th that it had received approval from the Ministry of Food and Drug Safety for a domestic phase 2 clinical trial plan (IND) for its mitochondrial transplant treatment 'PN-101' targeting polymyositis and dermatomyositis....This phase 2 clinical trial will be conducted as a multi-institutional study with the participation of Professor Eun-Young Lee of the Department of Rheumatology at Seoul National University Hospital, Professor Hyun-Sook Kim of the Department of Rheumatology at Soonchunhyang University Seoul Hospital, and Professor Yeon-Ah Lee of the Department of Rheumatology at Kyung Hee University Hospital."

New P2 trial • Dermatomyositis

Mitochondrial transplantation as a novel therapeutic approach in idiopathic inflammatory myopathy. (PubMed, Ann Rheum Dis) - "PN-101 transplantation could serve as a novel treatment for IIM by enhancing mitochondrial repair and reducing inflammation in muscle tissues."

Journal • Dermatomyositis • Immunology • Inflammation • Myositis • Transplantation • GZMB

Mitochondrial Transplantation Ameliorates Pulmonary Fibrosis by Suppressing Myofibroblast Activation. (PubMed, Int J Mol Sci) - "Additionally, intravenous PN-101 administration alleviated bleomycin-induced fibrotic processes in the IPF mouse model with a therapeutic context. Our data indicate that PN-101 is a novel and potential therapeutic agent for IPF."

Journal • Bone Marrow Transplantation • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Transplantation

Mitochondrial transplantation exhibits neuroprotective effects and improves behavioral deficits in an animal model of Parkinson's disease. (PubMed, Neurotherapeutics) - "The results showed that PN-101 mitochondria isolated from human mesenchymal stem cells exhibited a neuroprotective effect against 1-methyl-4-phenylpyridinium, 6-hydroxydopamine and rotenone in dopaminergic cells and ameliorated dopaminergic neuronal loss in the brains of C57BL/6J mice injected 30 ​mg/kg of methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) intraperitoneally...Furthermore, intravenous mitochondrial treatment was associated with behavioral improvements during the pole test and rotarod test in the MPTP-induced PD mice. These dual effects of neuroprotection and anti-neuroinflammation support the potential for mitochondrial transplantation as a novel therapeutic strategy for PD."

Journal • Preclinical • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P1/2 | N=9 | Completed | Sponsor: Paean Biotechnology Inc. | Enrolling by invitation ➔ Completed | N=18 ➔ 9 | Trial completion date: Feb 2024 ➔ Oct 2023

Enrollment change • Trial completion • Trial completion date • Dermatomyositis • Immunology • Myositis • Transplantation

Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P1/2 | N=18 | Enrolling by invitation | Sponsor: Paean Biotechnology Inc.

Trial completion date • Dermatomyositis • Immunology • Myositis • Transplantation

Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P1/2 | N=18 | Enrolling by invitation | Sponsor: Paean Biotechnology Inc. | Trial primary completion date: Apr 2023 ➔ Oct 2023

Trial primary completion date • Dermatomyositis • Immunology • Myositis • Transplantation

Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P1/2 | N=18 | Enrolling by invitation | Sponsor: Paean Biotechnology Inc. | Not yet recruiting ➔ Enrolling by invitation | Trial completion date: Dec 2022 ➔ Apr 2023 | Initiation date: Aug 2021 ➔ Dec 2021 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Dermatomyositis • Immunology • Myositis • Transplantation

Evaluate the Safety, Tolerability and Efficacy of PN-101 in Patients With Refractory Polymyositis or Dermatomyositis (clinicaltrials.gov) - P1/2; N=18; Not yet recruiting; Sponsor: Paean Biotechnology Inc.

New P1/2 trial • Dermatomyositis • Immunology • Myositis