Randomized, double-blind, placebo-controlled, dose-increased clinical trials of dose groups to assess safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics after repeated oral administration of AVI-CO-004 for 10 days to male HIV-infected subjects

开始日期2020-08-16

申办/合作机构

Avixgen, Inc.

KCT0005182 / Not yet recruiting临床1期

A First-in-Human, Phase 1, Randomized, Multi center, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy of AVI-3307 Cream in Healthy Adult Subjects and Atopic Dermatitis Patients

开始日期2020-08-03

申办/合作机构

Avixgen, Inc.

KCT0005175 / Not yet recruiting临床1期

A Randomized, Placebo-Controlled, Double-Blind, Phase I Study to Evaluate the Safety and Pharmacokinetics of eye drop AVI-4015 in healthy volunteers

开始日期2020-07-13

申办/合作机构

Avixgen, Inc.

100 项与 Avixgen, Inc. 相关的临床结果

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0 项与 Avixgen, Inc. 相关的专利（医药）

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项与 Avixgen, Inc. 相关的文献（医药）

2023-08-11·ACS infectious diseases

Identification of a Non-Nucleoside Reverse Transcriptase Inhibitor against Human Immunodeficiency Virus-1.

Article

作者: You, Ji Chang ; Han, Ri ; Oh, Kyungsoo ; Kim, Min-Jung ; Lee, Yoonji ; Yu, Kyung Lee

The HIV-1 infection epidemic remains a global health problem. Current antiretroviral treatments are effective in controlling the progression of a severe infection. However, the emergence of drug resistance requires an urgent identification of new treatment regimes. HIV-1 reverse transcriptase (RTs) has been a successful therapeutic target owing to its high specificity and potent antiviral properties; therefore, it has become an essential component of current HIV-1 standard treatments. This study identified a new HIV-1 RTs inhibitor (Compound #8) that is structurally unique and greatly effective against HIV-1 through chemical library screening and a medicinal chemistry program by analyzing the structure-activity relationship (SAR). Further analysis of molecular docking and mechanisms of action demonstrated that Compound #8 is a novel type of HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) with a flexible binding mode. Therefore, it exhibits great therapeutic potential when combined with other existing HIV-1 drugs. Our current studies suggest that Compound #8 is a promising novel scaffold for the development of new HIV-1 treatments.

2022-09-01·Osteoarthritis and cartilage2区 · 医学

Characterization of rhodanine derivatives as potential disease-modifying drugs for experimental mouse osteoarthritis

2区 · 医学

Article

作者: Kwak, J-S ; Chun, J-S ; Shin, Y ; Im, Y J ; Yang, J ; Kim, S K ; Chang You, J ; Lee Yu, K ; Choi, J H ; Kim, M-J ; Kim, H-J ; Lee, Y

OBJECTIVE:

This study was performed to characterize selected rhodanine derivatives as potential preclinical disease-modifying drugs for experimental osteoarthritis (OA) in mice.

METHODS:

Three rhodanine derivatives, designated rhodanine (R)-501, R-502, and R-503, were selected as candidate OA disease-modifying drugs. Their effects were evaluated by intra-articular (IA) injection in OA mouse models induced by DMM (destabilization of the medial meniscus) or adenoviral overexpression in joint tissues of hypoxia-inducible factor (HIF)-2α or zinc importer ZIP8. The regulatory mechanisms impacted by the rhodanine derivatives were examined in primary-culture chondrocytes and fibroblast-like synoviocytes (FLS).

RESULTS:

All three rhodanine derivatives inhibited OA development caused by DMM or overexpression of HIF-2α or ZIP8. Compared to vehicle-treated group, for example, IA injection of R-501 in DMM-operated mice reduced median OARSI grade from 3.78 (IQR 3.00-5.00) to 1.89 (IQR 0.94-2.00, P = 0.0001). R-502 and R-503 also reduced from 3.67 (IQR 2.11-4.56) to 2.00 (IQR 1.00-2.00, P = 0.0030) and 2.00 (IQR 1.83-2.67, P = 0.0378), respectively. Mechanistically, the rhodanine derivatives inhibited the nuclear localization and transcriptional activity of HIF-2α in chondrocytes and FLS. They did not bind to Zn²⁺ or modulate Zn²⁺ homeostasis in chondrocytes or FLS; instead, they inhibited the nuclear localization and transcriptional activity of the Zn²⁺-dependent transcription factor, MTF1. HIF-2α, ZIP8, and interleukin-1β could upregulate matrix-degrading enzymes in chondrocytes and FLS, and the rhodanine derivatives inhibited these effects.

CONCLUSION:

IA administration of rhodanine derivatives significantly reduced OA pathogenesis in various mouse models, demonstrating that these derivatives have disease-modifying therapeutic potential against OA pathogenesis.

2021-09-14·Translational vision science & technology3区 · 医学

In Vivo Efficacy of Imatinib Mesylate, a Tyrosine Kinase Inhibitor, in the Treatment of Chemically Induced Dry Eye in Animal Models

3区 · 医学

ArticleOA

作者: Sung, Bokyung ; Baek, Yi-Yong ; Kim, Do-Hyung ; Hyon, Joon Young ; Go, Hyeon-Kyu ; Choi, Jun-Sub ; You, Ji Chang

Purpose:

Dry eye disease (DED) is a multifactorial disorder of the tears and ocular surface accompanied by ocular discomfort, visual disturbance, tear film instability, and ocular surface inflammation. In the present study, we evaluated the efficacy of the tyrosine kinase inhibitor imatinib mesylate for the treatment of DED.

Methods:

Experimental models of DED were generated in Sprague Dawley rats using a combination of benzalkonium chloride (BAC) with atropine sulfate and in New Zealand White rabbits using BAC. The animals were treated twice daily with eye drops of vehicle, imatinib (0.01%-0.3%), or a positive control (Restasis). The improvement in DED due to imatinib was assessed by staining with fluorescein, lissamine green, impression cytology, and histological analysis. In addition, immunofluorescence staining was performed at the end of the study to evaluate the inflammatory response in the ocular surface.

Results:

Topical application of imatinib significantly reduced ocular surface damage compared with vehicle-treated animals. Imatinib restored the morphology and structure of the conjunctival epithelium and reduced the recruitment of immune cells in the corneal epithelium. Furthermore, imatinib significantly reduced the impression cytology score, thus demonstrating that imatinib prevents the loss of goblet cells in DED animal models. The therapeutic efficacy of imatinib was similar to or better than that of cyclosporine treatment.

Conclusions:

In this study, we provide an animal in vivo proof of concept of the therapeutic potential of imatinib for the treatment of DED.

Translational Relevance:

With this study we show the possibility of developing imatinib as a new ophthalmic drop to treat DED.

项与 Avixgen, Inc. 相关的新闻（医药）

2023-05-25

·生物谷

Avixgen，优质研发管线研发情况

公开干眼症、黄斑变性等眼科疾病和过敏性皮炎的研发管线研发情况公开干眼症、黄斑变性等眼科疾病和过敏性皮炎的研发管线研发情况 - 通过成功开展临床试验，提高新药研发管线的价值近日，DxVx决定收购约63%的Avixgen股份，并公开了Avixgen拥有的研发管线研发情况。Avixgen是一家新药研发专业公司，拥有干眼症、黄斑变性等眼科疾病和过敏性皮炎等优质研发管线。 Avixgen目前正在关注最有可能实现商业化的干眼症。通过盆唐首尔大学医院、首尔大学医院总院、三星首尔医院及天主教圣母医院等完成韩国1期临床试验，并计划在韩国和美国同时开展2期临床试验。通过药物再造战略，在减少现有药物或机制的相当一部分副作用的同时，正在研发长期有效的治疗药。老年性黄斑变性治疗药目前正在研发注射剂和滴眼剂。期待在抑制新生血管、血管内皮生长因子受体等方面，通过与现有治疗药不同的机制，研发出提高功效、减少副作用的新药。尤其，针对黄斑变性滴眼剂，在兔子身上，投药量比现有药物少5倍~20倍以上也能确保抗新生血管效力，在现有药物的效力消失的投药28天后也维持了抗新生血管效力。针对注射剂，已经通过首尔大学医院（总院）及首尔波拉美医院完成了1期临床试验。针对过敏性皮炎治疗药，则通过非类固醇物质，正在研发改善炎症疾病的新机制。期待能缓解使用现有治疗药时出现的瘙痒症和灼热感、疱疹性湿疹及皮肤病等的副作用，计划通过牙山医院、新村SEVERANCE医院、H+阳地医院等，明年上半年重新开始1期临床试验。 Avixgen的相关人士表示：“公司将通过参与新药研发国策课题和扩大与母公司DxVx之间的合作，迅速开展研发管线的研发工作，计划在2024年通过技术评价，并在2025年推进IPO。”，并说道：“公司将持续确保优秀人才，成功开展Avixgen拥有的干眼症、黄斑变性等眼科相关研发管线的临床试验，由此进一步提高研发管线的价值。” 另外，黄斑变性的全球市场规模在去年达到约15万亿韩元，预计在2030年接近约30万亿韩元，干眼症和过敏性皮炎治疗药的全球市场规模分别从去年的15万亿韩元、18万亿韩元，到2030年将达到30万亿韩元、36万亿韩元。（来源：Biospace，Market.US） <黄斑变性治疗药市场规模> <干眼症滴眼剂市场规模>

临床1期临床2期IPO并购

2023-05-24

·PRNewswire

Avixgen accelerates the progress on new drug pipeline development

- Pipeline development updates on age related macular degeneration, dry eye disease and atopic dermatitis SEOUL, South Korea, May 24, 2023 /PRNewswire/ -- DxVx has released development updates on the pipelines of its recently acquired company, Avixgen. DxVx acquired about 63% stake of Avixgen, which is a new drug development company with strong pipeline in ophthalmic diseases such as age related macular degeneration, dry eye disease as well as atopic dermatitis. Avixgen is currently focusing on dry eye disease which is believed to have the highest potential for commercialization. Avixgen completed Phase 1 clinical trials in Korea through Seoul National University Bundang Hospital, Seoul National University Hospital and Catholic University St. Mary Hospital and plans to conduct Phase 2 clinical trials in Korea and United States simultaneously. Avixgen's main goal for this pipeline is to develop a drug with the long lasting efficacy and reduce side effects comparing to existing drugs. Treatments for age related macular degeneration are being developed as injections and eye drops. The new treatments are expected to have higher efficacy with less side effects owing to the novel mechanism different from existing treatments. In particular, in case of eye drops for age related macular degeneration, anti-angiogenic effects were confirmed at doses 5 to 20 times lower than those of existing drug in rabbit tests and still maintained the efficacy even 28 days after treatment, while the existing drugs' efficacy was completely disappeared. For the injection, Phase 1 clinical trials have been successfully completed at Seoul National University Hospital and Seoul National University Boramae Medical Center. Atopic dermatitis treatment is being developed with a new mechanism to improve inflammatory diseases using non-steroidal substances. It is expected to reduce side effects such as itching and burning feeling, eczema and dermatosis triggered by conventional treatments. Phase 1 clinical trials is scheduled to resume in the first half of next year at Hyundai Asan Meical Center, Sinchon Severance Hospital and H Plus Yangi Hospital An official from Avixgen said "Through participation in national drug development projects and collaboration with its parent company DxVx, we plan to expedite the pipeline development and pursue an IPO in 2025 ultimately" Meanwhile, the global drug market for macular degeneration is expected to reach nearly $18 billion and almost $7 billion for dry eye drug market in 2030 (Source: biospace.com, market.us). SOURCE Dx&Vx

临床1期并购

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当前项目

药物(靶点)	适应症	全球最高研发状态

AVI-4015 ( DDR1 )	干眼症更多	临床2期
AVI-CO-004	获得性免疫缺陷综合征更多	临床2期
Timtraxanib ( VEGFR2 )	视网膜变性更多	临床1期
Claficapavir ( HIV-1 protease )	HIV感染更多	临床前
AVI-3307	特应性皮炎更多	无进展