更新于：2024-06-30

MIV-711

更新于：2024-06-30

概要

研发状态

概要

基本信息

药物类型

小分子化药

别名

N-[(2S)-1-[(3aS,6R,6aR)-6-Ethynyl-3-oxohexahydro-2H-furo[3,2-b]pyrrol-4-yl]-4-methyl-1-oxopentan-2-yl]-4-[5-fluoro-2-(4-methylpiperazin-1-yl)-1,3-thiazol-4-yl]benzamide hydrochloride、MV-076159、MV-711

靶点

CTSK

作用机制

CTSK抑制剂(组织蛋白酶K抑制剂)

治疗领域

皮肤和肌肉骨骼疾病其他疾病

在研适应症-

非在研适应症

Legg-Calve-Perthes病膝关节炎

原研机构

Medivir AB

在研机构-

非在研机构

Medivir AB

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评快速通道 (美国)、孤儿药 (美国)、罕见儿科疾病 (美国)

关联

项与 MIV-711 相关的临床试验

NCT03443453 / Completed临床1期

A Single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics Following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers

This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers

开始日期2018-01-19

申办/合作机构

Medivir AB

EUCTR2016-001096-73-BG / Not yet recruiting临床2期

An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients with Knee Joint Osteoarthritis

开始日期2016-09-13

申办/合作机构

Medivir AB

NCT03037489 / Completed临床2期

An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

开始日期2016-09-01

申办/合作机构

Medivir AB

100 项与 MIV-711 相关的临床结果

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100 项与 MIV-711 相关的转化医学

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100 项与 MIV-711 相关的专利（医药）

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项与 MIV-711 相关的文献（医药）

2022-05-01·Clinical and experimental rheumatology3区 · 医学

Symptomatic and structural benefit of cathepsin K inhibition by MIV-711 in a subgroup with unilateral pain: post-hoc analysis of a randomised phase 2a clinical trial.

3区 · 医学

Article

作者: Byrjalsen, Inger ; Bowes, Mike A ; Öberg, Fredrik ; Conaghan, Philip G ; Andersen, Jeppe Ragnar ; Herder, Christina ; Bihlet, Asger Reinstrup

OBJECTIVES:

Osteoarthritis (OA) development programmes face challenges due to discordance between structural changes and symptoms. A novel cathepsin-K inhibitor, MIV-711, recently reported structural benefits, but did not demonstrate a significant difference from placebo in symptoms. Previous work suggests that pain from non-target joints may confound OA pain outcomes. We therefore conducted an exploratory analysis in participants with predominantly unilateral knee pain from the MIV-711-201 trial.

METHOSD:

Participants scoring below median contralateral knee NRS pain at baseline from the MIV-711-201 phase 2a clinical trial (n=119) were analysed by treatment group for differences in change from baseline in WOMAC pain, quantitative magnetic resonance imaging bone area and cartilage thickness with a repeated-measures mixed model adjusting for relevant co-variates.

RESULTS:

In the subgroup with unilateral knee pain, treatment with MIV-711 100 mg led to greater reduction in WOMAC pain compared to placebo (-5.0, 95% CI: -8.69 to -1.3, p=0.008), while 200 mg did not (-2.5, 95% CI: -6.5 to 1.6, p=0.23). MIV-711 treatment was associated with a reduced change in bone area compared to placebo (200 mg; -19.6 mm2 , 95% CI: -36.2 to -3.0, p=0.02, and 100 mg; -12.5 mm2 , 95% CI: -27.8 to 2.8, p=0.11,). No observed differences between treatment groups in cartilage thickness were found in this subgroup.

CONCLUSIONS:

In a subgroup with predominantly unilateral knee pain, significant reduction in OA pain by MIV-711 100 mg treatment was found, with concurrent beneficial structural effects, highlighting the importance of appropriate pain inclusion criteria in OA trials.

2021-01-01·Molecular biology reports4区 · 生物学

Inhibitory effect of cathepsin K inhibitor (ODN-MK-0822) on invasion, migration and adhesion of human breast cancer cells in vitro

4区 · 生物学

Article

作者: Premsingh, Riya ; Vashum, Yaongamphi ; Kottaiswamy, Amuthavalli ; Samuel, Shila ; Padmanaban, Abirami ; Soma, Mathangi ; Kalaiselvan, Parkavi

Approximately 90% of patients with advanced breast cancer develop bone metastases; an event that results in severe decrease of quality of life and a drastic deterioration in prognosis. Therefore, to increase the survival of breast cancer patients, the development of new therapeutic strategies to impair metastatic process and skeletal complications is critical. Previous studies on the role of cathepsin K (CTSK) in metastatic spreading led to several strategies for inhibition of this molecule such as MIV-711 (Medivir), balicatib and odanacatib (ODN) which were on trial in the past. The present study intended to assess the anti-metastatic efficacy of ODN in breast cancer cells. Human breast cancer cell lines MDA-MB-231 were treated with different concentrations of ODN and performed invasion, adhesion and migration assays and, RT-PCR and western blot to evaluate the effect of ODN on the metastatic potential of breast cancer cells. ODN markedly decreased wound healing cell migration, invasion and adhesion at a dose dependent manner. ODN inhibits cell invasion by decreasing the matrix metalloproteinase (MMP-9) with the upregulation of TIMP-1 expression. ODN effectively inhibited the phosphorylation of extracellular signal-regulated kinase (ERK), p38, and c-Jun N-terminal Kinase (JNK), and blocked the expression of β-integrins and FAK proteins. ODN also significantly inhibited PI3K downstream targets Rac1, Cdc42, paxillin and Src which are critical for cell adhesion, migration and cytoskeletal reorganization. ODN exerts anti-metastatic action through inhibition of signaling pathway for MMP-9, PI3K and MAPK. This indicates potential therapeutic effects of ODN in the treatment of metastatic breast cancer.

2020-01-21·Annals of internal medicine1区 · 医学

Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis

1区 · 医学

Article

作者: Guillard, Gwenael ; Kingsbury, Sarah R. ; Bethell, Richard ; Jansson, Åsa ; Graham, Philippa ; Sjögren, Niclas ; Rizoska, Biljana ; Conaghan, Philip G. ; Öhd, John ; Bowes, Michael A. ; Brett, Alan ; Wadell, Cecilia

Background:

MIV-711 is a novel selective cathepsin K inhibitor with beneficial effects on bone and cartilage in preclinical osteoarthritis models.

Objective:

To evaluate the efficacy, safety, and tolerability of MIV-711 in participants with symptomatic, radiographic knee osteoarthritis.

Design:

26-week randomized, double-blind, placebo-controlled phase 2a study with a 26-week open-label safety extension substudy. (EudraCT: 2015-003230-26 and 2016-001096-73).

Setting:

Six European sites.

Participants:

244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS).

Intervention:

MIV-711, 100 (n = 82) or 200 (n = 81) mg daily, or matched placebo (n = 77). Participants (46 who initially received 200 mg/d and 4 who received placebo) received 200 mg of MIV-711 daily during the extension substudy.

Measurements:

The primary outcome was change in NRS pain score. The key secondary outcome was change in bone area on magnetic resonance imaging (MRI). Other secondary end points included cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers. Outcomes were assessed over 26 weeks.

Results:

Changes in NRS pain scores with MIV-711 were not statistically significant (placebo, -1.4; MIV-711, 100 mg/d, -1.7; MIV-711, 200 mg/d, -1.5). MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels. Nine serious adverse events occurred in 6 participants (1 in the placebo group, 3 in the 100 mg group, and 2 in the 200 mg group); none were considered to be treatment-related.

Limitation:

The trial was relatively short.

Conclusion:

MIV-711 was not more effective than placebo for pain, but it significantly reduced bone and cartilage progression with a reassuring safety profile. This treatment may merit further evaluation as a disease-modifying osteoarthritis drug.

Primary Funding Source:

Medivir.

项与 MIV-711 相关的新闻（医药）

2024-04-30

·PRNewswire

MEDIVIR AB - INTERIM REPORT JANUARY - MARCH 2024

STOCKHOLM, April 30, 2024 /PRNewswire/ -- Preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months. January – March Financial summary for the quarter Net turnover amounted to SEK 0.5 (0.4) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively. Cash flow from operating activities amounted to SEK -35.0 (-16.1) million. Cash and cash equivalents at the end of the period amounted to SEK 153.4 (100.8) million Significant events during the quarter In January Tango Therapeutics announced that it has dosed the first patient with TNG348, a new USP1-inhibitor from the preclinical USP1 program in-licensed from Medivir in 2020. Positive results from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression were presented at the ASCO GI Symposium in San Francisco. In January, a directed issue to Hallberg Management AB was carried out amounting to approximately SEK 20 million before deduction of issuance costs. In February, a change in Medivir's nomination committee announced as Anders Hallberg, appointed by Healthinvest Partners, leaves the nomination committee and is replaced by Stefan Bengtsson, appointed by CA Fastigheter AB. Events after the end of the period In April it was announced that Medivir's partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701. In April it was announced that Medivir has completed a so-called Type C meeting with the FDA and that the company's preparations for the planned phase 2b study are continuing as planned, with a couple of adjustments in study design with limited impact on the timeline and size of the study. In April MIV-711 was granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), an uncommon hip disorder affecting children aged 2-12 years. Conference call for investors, analysts and the media The Interim Report January - March 2024 will be presented by Medivir's CEO, Jens Lindberg. Time: Tuesday, April 30, 2024, at 10.00 (CET). To access the webcast and find information about the teleconference, please click HERE! The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message "Our goal is that the combination of fostrox and Lenvima® shall become the first approved alternative in second-line for patients with primary liver cancer. Preparations for our planned phase 2b study continue after the Type C meeting with the FDA, strengthened by the fact that patients in the ongoing phase 1b/2a study continue to benefit from treatment with fostrox + Lenvima longer than expected and that the outcome continues to improve. Medivir's proprietary candidate drug fostrox is a targeted, smart chemotherapy that selectively kills cancer cells in the liver. Fostrox + Lenvima constitutes a unique, potential combination of complementary medicines that is showing promising results in Medivir's ongoing phase 1b/2a study. At the international ASCO-GI congress in San Francisco in January, results were presented for fostrox + Lenvima showing that the proportion of patients achieving a clinically relevant reduction in their liver tumor is greater than what would be expected with a second-line treatment. Data evaluated by investigators and local radiologists showed that the Objective Response Rate (ORR) was 25 percent (RECIST v1.1), a significantly higher rate than the 5–10 percent shown for second-line treatment of HCC in previous studies. The update also showed continued good tolerability without any new unexpected side effects. As the patients remain on treatment longer than expected, the clinical efficacy has continued to improve. At the time of writing, ~30 percent of patients remain on treatment in the study. The median time to progression has now increased further to 7 months, compared to 5 months at ASCO GI, significantly longer than previous studies in second-line HCC have shown. The patient who has benefited the longest remains on treatment after 20 months with continued partial response. The readout of the study as a whole is expected to be completed by the end of 2024, depending on how long the last patients continue to benefit from the treatment. Our data has been met with great interest and the discussions with leading global experts, not least at ASCO GI, have confirmed what the combination fostrox + Lenvima could mean in the second-line treatment of HCC, where patients today are without any approved treatment alternative. With the increasingly exciting data from the study, the opportunity emerges to become the first approved drug treatment in a market worth ~$2.5 billion annually. We have therefore put in a higher gear to ensure maximum speed forward in fostrox's development program to create the possibility of a so-called accelerated approval. Somewhat simplified, it can be described as a conditional regulatory approval that enables prescribing to patients where the data must later be substantiated in a follow-up confirmatory phase 3 study. This means an opportunity for fostrox to reach patients up to three years faster than would otherwise be the case. During the quarter, we also had a Type C meeting with the FDA to discuss the study design. The FDA provided clarifying guidance, which means we are now approaching the final study design for the planned phase 2b study, which is proceeding as previously planned. Parallel to these measures, the discussions we are having with potential cooperation partners for fostrox continue. Also, when it comes to the projects Medivir previously licensed out to partners, the development is exciting. In January, Tango Therapeutics initiated a phase 1/2 study and dosed the first patient with TNG348, a USP-1 inhibitor developed from the preclinical USP1 program in-licensed from Medivir in 2020. In April, our partner Vetbiolix, a veterinary biotech company based in France, could report positive results from a clinical Proof-of-Concept study in canine periodontitis disease with its drug candidate VBX-1000, formerly known as MIV-701 which was out-licensed to Vetbiolix in 2019. In addition, our project for partnership MIV-711 was granted Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease from the FDA. Aside from that this creates opportunity for partnerships and future revenue, it also demonstrates the quality of Medivir's research. The continued clinical development of fostrox is our focus and the promising data showing further improvement in clinical efficacy in second-line HCC reinforces our belief that fostrox can become an effective anti -cancer drug that makes a real difference to patients. There is a clear need and an obvious place for fostrox in the treatment landscape. The goal is to become the first approved alternative in second-line for patients with primary liver cancer. I look forward to keeping you informed of Medivir's continued development." Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: [email protected] This report has not been subject to auditors' review. The information was submitted for publication at 08.30 CET on April 30, 2024 This information was brought to you by Cision The following files are available for download: SOURCE Medivir

临床2期孤儿药临床结果财报

2024-04-25

·PRNewswire

FDA grants Medivir´s MIV-711 Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Legg-Calvé-Perthes Disease

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Medivir AB (NASDAQ: MVIR) (STO: MVIR) , a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that its selective cathepsin K inhibitor, MIV-711, has been granted Rare Pediatric Disease Designation (RPDD) as well as Orphan Drug Designation (ODD) for the treatment of Legg-Calvé-Perthes Disease (LCPD). The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years of age. Pediatric diseases recognized as "rare", affect fewer than 200,000 people in the United States. With a RPDD, MIV-711 qualifies to receive fast track review and upon marketing approval in LCPD, the Company may be eligible to receive a Priority Review Voucher from the FDA. The voucher can be redeemed to receive priority review for any subsequent marketing application or may be sold to another company for their use. - "LCPD is a disease, with a significant impact on daily life as well as risk for long-term sequalae, for which there are no available effective treatments. Children with LCPD are more likely to suffer from obesity and depression due to the forced immobility as a consequence of the disease. In more than half of the children, the affected leg becomes shorter than the healthy leg and about 50% end up with a deformed hip joint where ultimately osteoarthritis develops. We are delighted that MIV-711 has been granted RPDD by the FDA with the potential to become the first approved treatment option. We see partnership as an attractive way to move forward with MIV-711 to ensure speed of development," said Jens Lindberg, CEO of Medivir. To gain RPDD, there must be supportive data suggesting that the drug may be effective in the disease. MIV-711 has shown, in an LCPD-specific animal model, the ability to prevent femoral head deformity and positive impact on biomarker of bone degradation without negatively impacting normal bone formation. Similarly, clinical studies have shown that MIV-711 prevents bone degradation in patients with osteoarthritis, further supporting the potential clinical benefit in LCDP. Cathepsin K is the main cysteine protease involved in bone resorption and cartilage degradation by osteoclasts, through the breakdown of key bone matrix proteins. Cathepsin K inhibition protects the damaged bone by reducing bone resorption and promoting bone formation, thereby addressing the key mechanisms causing pathological changes in LCPD, with potential to minimize long-term negative effects. Selective inhibition of cathepsin K has the potential to provide clinical benefit in diseases characterized by excessive bone resorption, including additional pediatric bone disorders. For additional information, please contact: Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100. E-mail: [email protected] About Legg-Calvé-Perthes Disease Legg-Calvé-Perthes disease (LCPD) is a childhood hip disorder initiated by a disruption of blood flow to the head of the femur. Due to the lack of blood flow, the bone dies (osteonecrosis or avascular necrosis) and stops growing. Over time, healing occurs by new blood vessels infiltrating the dead bone and removing the necrotic bone which leads to a loss of bone mass and a weakening of the femoral head. The condition is most commonly found in children between the ages of 4 and 8, but it can occur in children between the ages of 2 and 15. It is estimated to affect about 10 in 100.000 children per year in the USA. It results in permanent deformity of the femoral head in many children, which increases the risk of developing osteoarthritis in adults. About MIV-711 MIV-711 is a potent and selective inhibitor of cathepsin K, the principal protease involved in breaking down collagen in bone and cartilage. It has been shown to slow, stop or reverse the progressive degeneration of joints affected by osteoarthritis. By inhibiting cathepsin K and increased/excessive activity of osteoclasts, MIV-711 has the potential to prevent degradation of bone and cartilage and counteract the osteonecrosis induced by lack of blood flow, to prevent femoral head deformity and long-term negative effects as well as positively impact Quality of Life. About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. . This information was brought to you by Cision The following files are available for download: SOURCE Medivir

孤儿药快速通道

2023-02-15

·BioSpace

Medivir AB - Year-End Report January - December 2022

HUDDINGE, Sweden, Feb. 15, 2023 /PRNewswire/ -- Continued strong recruitment in the dose escalation part of the fostrox study. October – December Financial summary for the quarter Net turnover amounted to SEK 2.3 (13.9) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -17.9 (-23.5) million. Basic and diluted earnings per share amounted to SEK -0.32 (-0.44) and SEK -0.32 (-0.44) respectively. Cash flow from operating activities amounted to SEK -24.7 (-5.4) million. Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million. Significant events during the quarter In October the nomination committee was appointed ahead of the 2023 AGM. The Nomination Committee consists of Karl Tobieson (Chairman), appointed by Linc AB, Richard Torgerson, appointed by Nordea Investment Funds, Anders Hallberg, appointed by HealthInvest Partners and Uli Hacksell, Chairman of the Board, Medivir AB. Pia Baumann was recruited in November as new Chief Medical Officer, taking office in February 2023. Medivir presented new data, showing additive efficacy of fostrox in combination with anti-PD1 in experimental tumor models, at the SITC Immunotherapy Conference in November. Medivir completed a pre-IND meeting with the US Food and Drug Administration and received positive feedback on the development plan in preparation for an IND for its candidate drug fostrox. January – December Financial summary for the period Net turnover amounted to SEK 4.4 (25.5) million. The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -84.8 (-59.5) million. Basic and diluted earnings per share amounted to SEK -1.59 (-1.20) and SEK -1.59 (-1.20) respectively. Cash flow from operating activities amounted to SEK -101.8 (-48.7) million. Cash and cash equivalents at the end of the period amounted to SEK 117.4 (221.2) million. Significant events after the end of the period On January 11 it was announced that Medivir's partner Infex Therapeutics has been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA) for MET-X, the company's broad spectrum Metallo-beta-lactamase inhibitor (MBLI) based on Medivir's MBLI program. Conference call for investors, analysts and the media The Year-End Report January - December 2022 will be presented by Medivir's CEO, Jens Lindberg. Time: Wednesday, February 15, 2023, at 14.00 (CET). Phone numbers for participants from: Sweden + 46 8 505 163 86 Europe +44 20 3198 4884 US +1 412-317 6300 Pin code 1872625# The conference call will also be streamed via a link on the website: The presentation will be available on Medivir's website after completion of the conference. CEO's message Taking over as CEO of Medivir in January 2022, I was given the privilege of leading a great team to develop cancer medicines that can really make a difference. Our main focus in 2022 has been the continued clinical development of Medivir's proprietary candidate drug fostroxacitabine bralpamide (fostrox). Fostrox has the potential to become the first liver-targeted and orally administered drug that can help patients with various cancers of the liver. Its unique mechanism of action in liver cancer makes fostrox attractive to combine with several other drugs for the treatment of hepatocellular carcinoma HCC. The combination study is progressing as expected in ongoing dose escalation cohorts. The measures taken to accelerate patient recruitment at the end of the summer had the desired effect. Since then, interest in the study has been very high, with patients standing in line waiting for new cohorts to be opened. We look forward to shortly establishing the recommended dose for the first combination arm and subsequently initiating the phase 2a portion of the study. We have also presented new data for fostrox during the year. At the EASL Liver Cancer Summit in February, Medivir was able to present biomarker data from the phase 1 study with fostrox which, among other things, shows that fostrox provides a tumor-selective effect in the liver by causing the desired DNA damage and cell death in tumor cells in the liver but not in normal or healthy liver cells. At the SITC Immunotherapy Conference in November, Medivir presented new data showing that the combination of fostrox with anti-PD1 provides an improved effect in experimental tumor models and creates changes in the tumor microenvironment consistent with increased immune-mediated antitumor activity. It is also gratifying that we, at our pre-IND meeting with the US Food and Drug Administration FDA in December, received positive feedback on the IND preparation program for fostrox. We plan to submit an IND application to the US authority in 2023. In Medivir's business development, we focus on our two clinical projects for partnership, remetinostat and MIV-711. The data packages for both projects have been strengthened during the year and we continue our dialogues with external parties in order to find the best possible solution for each substance. Medivir's clinical project birinapant was out-licensed to IGM Biosciences in 2021. IGM is conducting ongoing clinical development work with the phase I clinical study in solid tumors with birinapant in combination with IGM's own DR5 agonist antibody IGM-8444. As of Q4 2022, IGM reported that the fourth dose-escalation cohort was ongoing and no dose-limiting toxicities were observed to date. Medivir's preclinical research program USP-1 was out-licensed in 2020 to US-based Tango Therapeutics, which announced that it has selected TNG348, a USP-1 inhibitor from this research program, as a development/drug candidate in the treatment of BRCA1/2 mutated cancers. Tango intends to open an IND in the US in 2023 for TNG348. Also our preclinical program MBLI aimed at addressing the threat of resistant bacteria appears to be moving towards clinical development. It is licensed to INFEX Therapeutics in England, which recently received QIDP-designation from the FDA and communicated its intention to initiate a phase 1 program in 2023. I would like to take this opportunity to wish our new CMO Pia Baumann a warm welcome to the team. Pia is a cancer specialist with solid experience in global drug development, which will be very valuable in the continued clinical development of fostrox. We are glad to note the strong interest in fostrox and that the measures taken have yielded results in patient recruitment for the soon-to-be-completed phase 1b part of the study. Our work to ensure that fostrox can become an effective drug against liver cancer continues unabated. We hope and believe that it will lead to a treatment that makes a real difference for the patients and for the care and thus also for our shareholders. I look forward to keeping you informed of Medivir's continued development. Jens Lindberg Chief Executive Officer For further information, please contact Magnus Christensen, CFO Phone: +46 (0)8 5468 3100 E-mail: magnus.christensen@medivir.com This report has not been subject to auditors' review. The information was submitted for publication at 08.30 CET on February 15, 2023. The following files are available for download: View original content: SOURCE Medivir Company Codes: Stockholm:MVIRB, Bloomberg:MVIRB@SS, ISIN:SE0000273294, RICS:MVIRB.ST

临床1期高管变更财报

100 项与 MIV-711 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15599

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
膝关节炎	临床2期	保加利亚	Medivir AB	2016-01-28
膝关节炎	临床2期	格鲁吉亚	Medivir AB	2016-01-28
膝关节炎	临床2期	德国	Medivir AB	2016-01-28
膝关节炎	临床2期	摩尔多瓦	Medivir AB	2016-01-28
膝关节炎	临床2期	罗马尼亚	Medivir AB	2016-01-28
膝关节炎	临床2期	英国	Medivir AB	2016-01-28
Legg-Calve-Perthes病	临床前	美国	Medivir AB	2024-05-15

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02705625 (CTgov)	临床2期	膝关节炎	244	placebo	獵窪積網醖鹹獵願艱選(壓選鹹餘簾觸廠齋醖鹽) = 窪觸鹹簾憲淵鹹簾夢憲膚衊鬱衊願範鹹觸網繭 (鹽衊鏇衊網遞窪遞繭衊, 願齋壓襯餘獵廠獵襯獵 ~ 膚鹹齋壓艱觸範顧鬱選) 更多	-	2019-06-17
NCT03037489 (CTgov)	临床2期	膝关节炎	50	MIV-711-201+MIV-711 (Group A)	鑰鹹積齋鑰襯遞鹽鬱鏇(醖夢範範製餘鏇遞窪襯) = 壓鬱範糧獵構簾艱廠糧齋願鑰顧獵鹹範鑰憲糧 (壓衊餘窪構窪膚蓋製獵, 觸夢糧觸鬱艱鹹艱膚選 ~ 顧淵憲廠壓鹹齋遞簾鑰) 更多	-	2019-03-18
NCT03037489 (CTgov)	临床2期	膝关节炎	50	placebo+MIV-711 (Group B)	鑰鹹積齋鑰襯遞鹽鬱鏇(醖夢範範製餘鏇遞窪襯) = 遞鬱壓築範鹽膚繭選顧齋願鑰顧獵鹹範鑰憲糧 (壓衊餘窪構窪膚蓋製獵, 繭獵構遞製網獵構餘鬱 ~ 蓋糧鑰齋餘積淵獵鏇齋) 更多	-	2019-03-18