Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects

Part 1 Randimization, Double blinded, Placebo controlled, Dose escalation(10mg, 20mg, 40mg) of MIT-001 SC or IV single administration to evaluate safety, tolerability and PK in healthy adult.
Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in healthy adult.

开始日期2022-05-13

申办/合作机构

Mitoimmune Therapeutics, Inc.初创企业

KCT0006696 / Recruiting临床1/2期

A Phase IIa, Multi-center, Dose-finding Clinical Trial to Evaluate the Safety, the Efficacy for Prevention of Oral Mucositis and the Pharmacokinetics of MIT-001 in Patients with Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplantation

开始日期2022-02-11

申办/合作机构

Mitoimmune Therapeutics, Inc.初创企业

NCT05493800 / Active, not recruiting临床2期

A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

开始日期2022-02-01

申办/合作机构

Mitoimmune Therapeutics, Inc.初创企业

100 项与 MIT-001 相关的临床结果

登录后查看更多信息

100 项与 MIT-001 相关的转化医学

登录后查看更多信息

100 项与 MIT-001 相关的专利（医药）

登录后查看更多信息

项与 MIT-001 相关的文献（医药）

2024-04-01·Virus research

In vitro broad-spectrum antiviral activity of MIT-001, a mitochondria-targeted reactive oxygen species scavenger, against severe acute respiratory syndrome coronavirus 2 and multiple zoonotic viruses

Article

作者: Kim, Soon Ha ; Lee, Eun-Woo ; Yoo, Junsang ; Shin, Hye Jin ; Kim, Won-Keun ; Natasha, Augustine ; Shim, Hyun Soo ; Lim, Taehun ; Rajoriya, Shivani ; Im, Hyeonjoo ; Kim, Jong Woo ; Kim, Bohyeon

The COVID-19 pandemic caused by SARS-CoV-2 becomes a serious threat to global health and requires the development of effective antiviral therapies. Current therapies that target viral proteins have limited efficacy with side effects. In this study, we investigated the antiviral activity of MIT-001, a small molecule reactive oxygen species (ROS) scavenger targeting mitochondria, against SARS-CoV-2 and other zoonotic viruses in vitro. The antiviral activity of MIT-001 was quantified by RT-qPCR and plaque assay. We also evaluated the functional analysis of MIT-001 by JC-1 staining to measure mitochondrial depolarization, total RNA sequencing to investigate gene expression changes, and immunoblot to quantify protein expression levels. The results showed that MIT-001 effectively inhibited the replication of B.1.617.2 and BA.1 strains, Zika virus, Seoul virus, and Vaccinia virus. Treatment with MIT-001 restored the expression of heme oxygenase-1 (HMOX1) and NAD(P)H: quinone oxidoreductase 1 (NqO1) genes, anti-oxidant enzymes reduced by SARS-CoV-2, to normal levels. The presence of MIT-001 also alleviated mitochondrial depolarization caused by SARS-CoV-2 infection. These findings highlight the potential of MIT-001 as a broad-spectrum antiviral compound that targets for zoonotic RNA and DNA viruses, providing a promising therapeutic approach to combat viral infection.

2023-10-13·International journal of molecular sciences

Mitigating Age-Related Ovarian Dysfunction with the Anti-Inflammatory Agent MIT-001.

Article

作者: Kim, Soon Ha ; Lee, Jae Ho ; Cho, Min Jeong ; Jang, JuYi ; Kang, Min-Hee ; Koo, Yun Dong ; Kim, Yu Jin

Ovarian aging is a major obstacle in assisted reproductive medicine because it leads to ovarian dysfunction in women of advanced age. Currently, there are no effective treatments to cure age-related ovarian dysfunction. In this study, we investigated the effect of MIT-001 on the function of aged ovaries. Young and old mice were utilized in this study. MIT-001 was intraperitoneally administered, and the number of follicles and oocytes was analyzed. Each group was then retrieved for RNA and protein isolation. Total RNA was subjected to mRNA next-generation sequencing. Protein extracts from ovarian lysates were used to evaluate various cytokine levels in the ovaries. MIT-001 enhanced follicles and the number of oocytes were compared with non-treated old mice. MIT-001 downregulated immune response-related transcripts and cytokines in the ovaries of old mice. MIT-001 modulates the immune complex responsible for generating inflammatory signals and has the potential to restore the function of old ovaries and improve female fertility.

International journal of molecular sciences2区 · 生物学

MIT-001 Restores Human Placenta-Derived Mesenchymal Stem Cells by Enhancing Mitochondrial Quiescence and Cytoskeletal Organization

2区 · 生物学

ArticleOA

作者: Kim, Soon Ha ; Cho, Min Jeong ; Lee, Jae Ho ; Ko, Jung Jae ; Kim, Gi Jin ; Kim, Myung Joo ; Kim, Yu Jin ; Yu, Won Dong

Inflammation is a major cause of several chronic diseases and is reported to be recovered by the immuno-modulation of mesenchymal stem cells (MSCs). While most studies have focussed on the anti-inflammatory roles of MSCs in stem cell therapy, the impaired features of MSCs, such as the loss of homeostasis by systemic aging or pathologic conditions, remain incompletely understood. In this study, we investigated whether the altered phenotypes of human placenta-derived MSCs (hPD-MSCs) exposed to inflammatory cytokines, including TNF-α and IFN-γ, could be protected by MIT-001, a small anti-inflammatory and anti-necrotic molecule. MIT-001 promoted the spindle-like shape and cytoskeletal organization extending across the long cell axis, whereas hPD-MSCs exposed to TNF-α/IFN-γ exhibited increased morphological heterogeneity with an abnormal cell shape and cytoskeletal disorganization. Importantly, MIT-001 improved mitochondrial distribution across the cytoplasm. MIT-001 significantly reduced basal respiration, ATP production, and cellular ROS levels and augmented the spare respiratory capacity compared to TNF-α/IFN-γ-exposed hPD-MSCs, indicating enhanced mitochondrial quiescence and homeostasis. In conclusion, while TNF-α/IFN-γ-exposed MSCs lost homeostasis and mitochondrial quiescence by becoming over-activated in response to inflammatory cytokines, MIT-001 was able to rescue mitochondrial features and cellular phenotypes. Therefore, MIT-001 has therapeutic potential for clinical applications to treat mitochondrion-related inflammatory diseases.

项与 MIT-001 相关的新闻（医药）

2021-04-06

·BioSpace

MitoImmune Received FDA Clearance of IND Application for MIT-001, a Novel Anti-Inflammatory/Anti-Necrotic Therapy for Oral Mucositis in CCRT patients with Head and Neck Cancer

- MitoImmune initiates a Phase 2 trial of oral mucositis (OM) prevention in the first half of 2021 in the US and Korea, and is expanding OM treatment into hematopoietic stem cell transplantation clinical trials SEOUL, South Korea, April 6, 2021 /PRNewswire/ -- MitoImmune Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MIT-001, an innovative new drug candidate for the treatment of oral mucositis. MitoImmune plans to initiate a randomized, double–blind, placebo–controlled, multi–center trial in the first half of this year to evaluate the safety and efficacy of three different doses of MIT-001 compared to the placebo in prevention of OM in 60 patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing concurrent chemoradiotherapy (CCRT) in the US and South Korea. CCRT as a standard therapy for the treatment of a number of cancers can cause various side effects during the patient's treatment process. One of the most serious side effects, oral mucositis, accompanied by intensive inflammation and necrosis in the oral cavity, leads to large restrictions on the patient's dietary intake, increases the risk of severe infection, and even acts as a serious obstacle to CCRT. The unmet medical needs in developed countries remain very high, but there is no effective medical treatment for oral mucositis. "We are very pleased to be advancing our therapy of anti-inflammatory and anti-necrotic agent based on the novel action mechanism of mitochondria-targeted reactive oxygen species (ROS) scavenger into the clinical development in our quest to bring an innovative, better treatment to the patients who need them," said Soon-Ha Kim, Ph.D., chief executive officer of MitoImmune. In addition to phase 2 clinical trial for the patients with HNSCC in the United States and Korea, Mitoimune has recently received the IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a phase 2 clinical trial, to verify the safety and efficacy for OM in the lymphoma/ multiple myeloma patients with chemotherapy (CT) undergoing hematopoietic stem cell transplantation (HSCT). The first HSCT patient administration is planned for the 2nd quarter of this year. MIT-001 is a novel class of anti-inflammatory and anti-necrotic agent, specifically scavenging ROS in the mitochondria. This action mechanism of MIT-001 is expected to effectively suppress massive inflammation like oral mucositis occurring in the necrotic ulcers of oral mucous via removing excessive mitochondrial ROS, a major contributing factor in the CCRT-induced inflammation and necrosis. MitoImmune is a leading biotech company focusing on the development of mitochondrial therapeutics providing a breakthrough for life-threatening diseases based on its proprietary structural platform technology, which was scientifically verified through more than 40 published papers. MitoImmune is seeking to expand its R&D pipelines to chronic inflammatory disorders and neurodegenerative diseases. Homepage:

合作

100 项与 MIT-001 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
多发性骨髓瘤	临床2期	韩国	Mitoimmune Therapeutics, Inc.初创企业	2022-02-01
局部晚期头颈部鳞状细胞癌	临床2期	美国	Mitoimmune Therapeutics, Inc.初创企业	2021-06-21
局部晚期头颈部鳞状细胞癌	临床2期	韩国	Mitoimmune Therapeutics, Inc.初创企业	2021-06-21
口腔炎	临床2期	美国	Mitoimmune Therapeutics, Inc.初创企业	2021-06-21
口腔炎	临床2期	韩国	Mitoimmune Therapeutics, Inc.初创企业	2021-06-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2023	临床2期	口腔炎	16	MIT-001 5 mg	膚構憲積繭遞襯簾遞構(膚築構膚夢廠積鹽觸繭) = 艱觸選齋襯選膚壓選鑰繭遞齋網鹹構憲憲選餘 (築壓遞淵憲繭齋簾鹹夢 ) 更多	-	2023-12-09
				MIT-001 10 mg	膚構憲積繭遞襯簾遞構(膚築構膚夢廠積鹽觸繭) = 積餘憲築顧願顧窪齋鏇繭遞齋網鹹構憲憲選餘 (築壓遞淵憲繭齋簾鹹夢 ) 更多