Delving into the Latest Updates on Neuracle Science Co., Ltd. with Synapse

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Nervous System Diseases

Congenital Disorders

Skin and Musculoskeletal Diseases

Monoclonal antibody

Biosimilar

Antibody

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A glimpse into the focused therapeutic areas

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Disease Domain	Count

Nervous System Diseases	3
Endocrinology and Metabolic Disease	2
Immune System Diseases	2
Infectious Diseases	1

Top 5 Drug Type	Count

Monoclonal antibody	4
Biosimilar	3
Antibody	2
Synthetic peptide	1

Top 5 Target	Count

TAFA1(TAFA chemokine like family member 1)	1
GALR2(galanin receptor 2)	1
IL-4Rα(Interleukin-4 receptor subunit alpha)	1
RSV F protein(Respiratory syncytial virus F protein)	1
TNF-α(Tumor necrosis factor α)	1

The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy.
The main questions it aims to answer are:
1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of NS101 against FAM19A5
2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy.
Patients and heathly volunteers will be given NS101 15mg/kg or 30mg/kg systemically less than 3 months per protocol.
This is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.

Start Date19 Jan 2024

Sponsor / Collaborator

Neuracle Science Co., Ltd.Startup

[+3]

NCT05143463 / CompletedPhase 1

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous NS101 Infusion in Healthy Volunteers

Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study.
The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis.

Start Date04 Nov 2021

Sponsor / Collaborator

Neuracle Science Co., Ltd.Startup

100 Clinical Results associated with Neuracle Science Co., Ltd.

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0 Patents (Medical) associated with Neuracle Science Co., Ltd.

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10

Literatures (Medical) associated with Neuracle Science Co., Ltd.

31 Aug 2024·Experimental Neurobiology

FAM19A5 Deficiency Mitigates the Aβ Plaque Burden and Improves Cognition in Mouse Models of Alzheimer's Disease

Article

Author: Park, Sumi ; Hwang, Jong-Ik ; Lee, Sang-Myeong ; Yoo, Sangjin ; Lee, Minhyeok ; Seong, Jae Young ; Kwak, Hoyun ; Shahapal, Anu

FAM19A5, a novel secretory protein highly expressed in the brain, is potentially associated with the progression of Alzheimer's disease (AD). However, its role in the AD pathogenesis remains unclear. Here, we investigated the potential function of FAM19A5 in the context of AD. We generated APP/PS1 mice with partial FAM19A5 deficiency, termed APP/PS1/FAM19A5^+/LacZ mice. Compared with control APP/PS1 mice, APP/PS1/FAM19A5^+/LacZ mice exhibited significantly lower Aβ plaque density and prolonged the lifespan of the APP/PS1 mice. To further explore the therapeutic potential of targeting FAM19A5, we developed a FAM19A5 antibody. Administration of this antibody to APP/PS1 mice significantly improved their performance in the Y-maze and passive avoidance tests, indicating enhanced cognitive function. This effect was replicated in 5XFAD mice, a model of early-onset AD characterized by rapid Aβ accumulation. Additionally, FAM19A5 antibody treatment in 5XFAD mice led to enhanced exploration of novel objects and increased spontaneous alternation behavior in the novel object recognition and Y-maze tests, respectively, indicating improved cognitive function. These findings suggest that FAM19A5 plays a significant role in AD pathology and that targeting with FAM19A5 antibodies may be a promising therapeutic strategy for AD.

01 Nov 2020·Multiple Sclerosis JournalQ2 · MEDICINE

Serum FAM19A5 in neuromyelitis optica spectrum disorders: Can it be a new biomarker representing clinical status?

Q2 · MEDICINE

Article

Author: Seong, Jae Young ; Seok, Jin Myoung ; Seok, Hung Youl ; Kim, Byoung Joon ; Cho, Joong-Yang ; Oh, Jeeyoung ; Kang, Sa-Yoon ; Sohn, Eun-Hee ; Kim, Byung-Jo ; Cho, Eun Bee ; Ryu, Han-Wook ; Min, Ju-Hong ; Kim, Bong Chul ; Shin, Ha Young ; Lee, Hye Lim ; Huh, So-Young ; Lee, Sang-Soo ; Kwon, Oh-Hyun

Background: Neuromyelitis optica spectrum disorder (NMOSD) targets astrocytes and elevates the levels of astrocyte-injury markers during attacks. FAM19A5, involved in reactive gliosis, is secreted by reactive astrocytes following central nervous system (CNS) damage. Objective: To investigate the significance of serum FAM19A5 in patients with NMOSD. Methods: We collected clinical data and sera of 199 patients from 11 hospitals over 21 months. FAM19A5 levels were compared among three groups: NMOSD with positive anti-aquaporin-4 antibody (NMOSD-AQP4), other CNS demyelinating disease, and healthy controls. Results: The median serum FAM19A5 level was higher in the NMOSD-AQP4 (4.90 ng/mL (3.95, 5.79)) than in the other CNS demyelinating (2.35 ng/mL (1.83, 4.07), p < 0.001) or healthy control (1.02 ng/mL (0.92, 1.14), p < 0.001) groups. There were significant differences in the median serum FAM19A5 levels between the attack and remission periods (5.89 ng/mL (5.18, 6.98); 4.40 ng/mL (2.72, 5.13), p < 0.001) in the NMOSD-AQP4 group. Sampling during an attack ( p < 0.001) and number of past attacks ( p = 0.010) were independently associated with increased serum FAM19A5. Conclusion: Serum FAM19A5 was higher in patients with NMOSD-AQP4 and correlated with clinical characteristics. Thus, serum FAM19A5 may be a novel clinical biomarker for NMOSD-AQP4.

01 Jul 2020·Brain, Behavior, and ImmunityQ1 · MEDICINE

Serum FAM19A5 levels: A novel biomarker for neuroinflammation and neurodegeneration in major depressive disorder

Q1 · MEDICINE

Article

Author: Kim, Bongcheol ; Kang, Wooyoung ; Kang, Youbin ; Han, Kyu-Man ; Kang, June ; Tae, Woo-Suk ; Ham, Byung-Joo ; Seong, Jae Young ; Kim, Aram ; Kim, Yong-Ku

Chronic low-grade inflammation contributes to the pathophysiology of major depressive disorder (MDD). This study aimed to examine the association between serum levels of FAM19A5, a novel chemokine-like peptide that reflects reactive astrogliosis and inflammatory activation in the brain, and the neurodegenerative changes of MDD by investigating the correlation between serum FAM19A5 levels and cortical thickness changes in patients with MDD. We included 52 drug-naïve patients with MDD and 60 healthy controls (HCs). Serum FAM19A5 levels were determined in peripheral venous blood samples using a sandwich enzyme-linked immunosorbent assay. All participants underwent T1-weighted structural magnetic resonance imaging. Serum FAM19A5 levels were greater in patients with MDD than in HCs. In the MDD group, there were significant inverse correlations between serum FAM19A5 levels and cortical thickness in the prefrontal regions (i.e., the left inferior and right medial superior frontal gyri), left posterior cingulate gyrus, right cuneus, and both precunei, which showed significantly reduced thickness in patients with MDD compared to HCs. However, no correlation between serum FAM19A5 level and cortical thickness was observed in the HC group. The results of our study indicate that serum FAM19A5 levels may reflect reactive astrogliosis and related neuroinflammation in MDD. Our findings also suggest that serum FAM19A5 may be a potential biomarker for the neurodegenerative changes of MDD.

100 Deals associated with Neuracle Science Co., Ltd.

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100 Translational Medicine associated with Neuracle Science Co., Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

1

5

Preclinical

Phase 2 Clinical

1

2

Other

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

NS-101(Neuracle Science)	Hearing Loss, Sensorineural More	Phase 2 Clinical
Adalimumab Biosimilar (Neuracle Science) ( TNF-α )	Rheumatoid Arthritis More	Preclinical
NS-200 ( GALR2 )	Irritable Bowel Syndrome More	Preclinical
Palivizumab Biosimilar (Neuracle Science) ( RSV F protein )	Respiratory Syncytial Virus Infections More	Preclinical
NS400	-	Preclinical