NXC736 / Nextgen Biosci - LARVOL DELTA

Blocking S1P4 signaling attenuates brain injury in mice with ischemic stroke. (PubMed, J Adv Res) - "Using a functional S1P4 antagonist (NXC736) and a genetic tool for S1P4 knockdown, we identified S1P4 as a novel pathogenic factor in ischemic stroke."

Journal • Preclinical • Cardiovascular • CNS Disorders • Inflammation • Ischemic stroke • Vascular Neurology • NLRP3 • SPHK2

Safety and Efficacy of Oral NXC-736 in Adult Participants with Moderate and Severe Alopecia Areata (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: NEXTGEN Bioscience | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2

Enrollment open • Phase classification • Alopecia • Dermatology • Immunology

NXC736 Attenuates Radiation-Induced Lung Fibrosis via Regulating NLRP3/IL-1β Signaling Pathway. (PubMed, Int J Mol Sci) - "In addition, NXC736 treatment reduced the expression of epithelial-mesenchymal transition markers such as α-SMA, vimentin, and twist by blocking the Smad 2,3,4 signaling pathway. These data suggested that NXC736 is a potent therapeutic agent against RILF."

Journal • Fibrosis • Immunology • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • IL1B • NLRP3 • VIM

NextGen Bioscience begins Phase 2 clinical trial of NXC736, alopecia areata treatment drug [Google translation] (Pharm News) - "Nextgen Bioscience...received approval from the Ministry of Food and Drug Safety for the phase 2 clinical trial plan for NXC736, a hair loss treatment drug. NXC736 is a selective antagonist targeting sphingosine-1-phosphate receptors 1&4 and is being developed as an autoimmune treatment, and based on phase 1 clinical trials, it has been approved for phase 2 clinical trials for patients with alopecia areata."

New P2 trial • Alopecia • Immunology

Safety and Efficacy of Oral NXC-736 in Adult Participants With Severe Alopecia Areata (clinicaltrials.gov) - P2a | N=96 | Not yet recruiting | Sponsor: NEXTGEN Bioscience

New P2a trial • Alopecia • Immunology

Safety, pharmacokinetics and immune modulatory properties of NXC736, a first selective sphingosine 1-phosphate 1,4 (S1P1,4) receptor modulator, in healthy volunteers (EADV-Sp 2023) - "Discussion NXC736 was well tolerated after 14-day oral administration with no symptomatic bradycardia occurred. NXC736 was rapidly absorbed and metabolized to NXC736-P, resulting in the reduction of peripheral circulating lymphocytes."

Clinical • PK/PD data • Alopecia • Cardiovascular • Immune Modulation • Immunology • Ophthalmology

NextGen Bioscience announces NXC736 phase 1 clinical trial results at the European Dermatological Association [Google translation] (MedigateNews) - "NextGen Bioscience announced on the 19th that it announced the results of the phase 1 clinical trial of NXC736, an autoimmune disease treatment pipeline, at the European Academy of Dermatology (EADV 2023)....NextGen Bioscience conducted a clinical trial at Seoul National University Hospital after approval of the phase 1 clinical trial plan (IND) for NXC736, an autoimmune disease treatment, in August 2021 and ended in February 2023."

P1 data • Trial completion date • Immunology

The investigation of selective sphingosine-1 phosphate receptor 1&4 modulator to treat alopecia areata mouse model (P802) (IMMUNOLOGY 2023) - "Among the five S1PRs, S1PRs 1&4 modulator (NXC736, Nextgen Bioscience, South Korea) was used to confirm its efficacy in the treatment of AA...In addition, NKG2D level was decreased in effector CD8+ T cells. According to this result, we speculate that S1PR 1&4 modulator can be used as a promising treatment for AA."

Preclinical • Alopecia • CNS Disorders • Immunology • Multiple Sclerosis • CD8 • NKG2D • S1PR1

A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: NEXTGEN Bioscience | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Nov 2022 | Trial primary completion date: Jul 2022 ➔ Nov 2022

Trial completion • Trial completion date • Trial primary completion date

Nextgen Bioscience “Completed Phase 1 fibrosis treatment in the second half of this year” [Google translation] (Hankyung) - "Lee Bong-yong Announced...'In the second half of this year, we plan to complete the phase 1 clinical trial of a fibrosis treatment candidate and enter the clinical trial for an idiopathic pulmonary fibrosis (IPF) treatment.'...'We have a variety of candidate substances in clinical and non-clinical stages that target liver, lung and kidney-related fibrosis at the '2022 Korea Bio Investment Conference (KBIC 2022)' hosted by the Korea Economic Daily on the 12th.'...Nextgen received approval for phase 1 clinical trial from the Ministry of Food and Drug Safety in August last year for NXC736. Phase 1 is currently underway at Seoul National University Hospital. It is expected to be completed in the second half of this year."

Trial completion • Idiopathic Pulmonary Fibrosis