This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

开始日期2023-10-30

申办/合作机构

Mezzion Pharma Co., Ltd.

NCT03430583 / Unknown statusN/A

Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study

A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.

开始日期2018-02-20

申办/合作机构

Mezzion Pharma Co., Ltd.

[+1]

NCT03013751 / Unknown status临床3期

A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation

This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.

开始日期2017-01-01

申办/合作机构

Mezzion Pharma Co., Ltd.

[+1]

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项与 Mezzion Pharma Co., Ltd. 相关的文献（医药）

2020-02-25·Circulation1区 · 医学

Results of the FUEL Trial

1区 · 医学

Article

作者: Goldberg, David J. ; Nowlen, Todd T. ; Hamstra, Michelle S. ; Kim, Seong-Ho ; DiMaria, Michael V. ; McCrindle, Brian W. ; Frischhertz, Benjamin P. ; Goldstein, Bryan H. ; Pearson, Gail D. ; Paridon, Stephen M. ; Urbina, Elaine M. ; Garg, Ruchira ; Schumacher, Kurt R. ; McHugh, Kimberly E. ; Penny, Daniel J. ; Frommelt, Peter C. ; Zak, Victor ; Ginde, Salil ; Mackie, Andrew S. ; Stylianou, Mario P. ; Davis, Christopher K. ; Yetman, Anji T. ; McBride, Michael G. ; Rathge, Kathleen A. ; Kim, Gi Beom ; Wagner, Jonathan B. ; Files, Matthew D. ; Shillingford, Amanda J. ; Petit, Christopher J. ; Payne, R. Mark ; Russell, Mark W. ; Menon, Shaji C. ; Sabati, Arash A. ; Rhodes, Jonathan ; Shahanavaz, Shabana ; Jacobs, Jeffrey P. ; Pemberton, Victoria L. ; Woyciechowski, Stacy ; Hill, Kevin D. ; Yeager, James L. ; Richmond, Marc E. ; John, Anitha S.

Background::

The Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking.

Methods::

The FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide.

Results::

Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (–0.2%) in the placebo group ( P =0.071). Analysis at ventilatory anaerobic threshold demonstrated improvements in the udenafil group versus the placebo group in oxygen consumption (+33±185 [3.2%] versus –9±193 [–0.9%] mL/min, P =0.012), ventilatory equivalents of carbon dioxide (–0.8 versus –0.06, P =0.014), and work rate (+3.8 versus +0.34 W, P =0.021). There was no an improvement in myocardial performance index (–0.02 vs 0.01, P =0.030), but no change in reactive hyperemia index, or serum brain-type natriuretic peptide level.

Conclusions::

In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.

Clinical Trial Registration::

URL: https://www.clinicaltrials.gov . Unique identifier: NCT02741115.

2018-07-01·American heart journal2区 · 医学

Design and rationale of the Fontan Udenafil Exercise Longitudinal (FUEL) trial

2区 · 医学

Review

作者: Goldberg, David J ; Hamstra, Michelle S ; Yeager, James L ; Pemberton, Victoria L ; Menon, Shaji C ; Rhodes, Jonathan ; Stylianou, Mario P ; Trachtenberg, Felicia ; Schumacher, Kurt R ; McCrindle, Brian W ; Files, Matthew D ; Frommelt, Peter C ; Pearson, Gail D ; Zak, Victor ; Paridon, Stephen M ; McHugh, Kimberly E ; Goldstein, Bryan H ; Penny, Daniel J ; Payne, R Mark ; Richmond, Marc E

The Fontan operation creates a circulation characterized by elevated central venous pressure and low cardiac output. Over time, these characteristics result in a predictable and persistent decline in exercise performance that is associated with an increase in morbidity and mortality. A medical therapy that targets the abnormalities of the Fontan circulation might, therefore, be associated with improved outcomes. Udenafil, a phosphodiesterase type 5 inhibitor, has undergone phase I/II testing in adolescents who have had the Fontan operation and has been shown to be safe and well tolerated in the short term. However, there are no data regarding the long-term efficacy of udenafil in this population. The Fontan Udenafil Exercise Longitudinal (FUEL) Trial is a randomized, double-blind, placebo-controlled phase III clinical trial being conducted by the Pediatric Heart Network in collaboration with Mezzion Pharma Co, Ltd. This trial is designed to test the hypothesis that treatment with udenafil will lead to an improvement in exercise capacity in adolescents who have undergone the Fontan operation. A safety extension trial, the FUEL Open-Label Extension Trial (FUEL OLE), offers the opportunity for all FUEL subjects to obtain open-label udenafil for an additional 12 months following completion of FUEL, and evaluates the long-term safety and tolerability of this medication. This manuscript describes the rationale and study design for FUEL and FUEL OLE. Together, these trials provide an opportunity to better understand the role of medical management in the care of those who have undergone the Fontan operation.

2017-06-01·American heart journal2区 · 医学

Results of a phase I/II multi-center investigation of udenafil in adolescents after fontan palliation

2区 · 医学

Article

作者: Goldberg, David J ; Maunsell, Eileen ; Yeager, James L ; Hamstra, Michelle S ; deVries, Tina M ; Kaltman, Jonathan R ; Menon, Shaji C ; Paridon, Stephen M ; Payne, R Mark ; Chen, Shan ; Stylianou, Mario ; Zak, Victor ; Radojewski, Elizabeth A ; Schumacher, Kurt R ; Goldstein, Bryan H ; Mital, Seema

BACKGROUND:

The Fontan operation results in a circulation that is dependent on low pulmonary vascular resistance to maintain an adequate cardiac output. Medical therapies that lower pulmonary vascular resistance may augment cardiac output and improve long-term outcomes.

OBJECTIVES:

This phase I/II clinical trial conducted by the Pediatric Heart Network was designed to evaluate short-term safety, pharmacokinetics (PK), and preliminary efficacy of udenafil in adolescents following Fontan.

METHODS:

A 5-day dose-escalation trial was conducted in five study cohorts of six subjects each (37.5, 87.5, and 125 mg daily, 37.5 and 87.5 mg by mouth twice daily). A control cohort with 6 subjects underwent exercise testing only. Adverse events (AEs) were recorded, PK samples were collected on study days six through eight, and clinical testing was performed at baseline and day five.

RESULTS:

The trial enrolled 36 subjects; mean age 15.8 years (58% male). There were no significant differences in subject characteristics between cohorts. No drug-related serious AEs were reported during the study period; 24 subjects had AEs possibly or probably related to study drug. Headache was the most common AE, occurring in 20 of 30 subjects. The 87.5 mg bid cohort was well tolerated, achieved the highest maximal concentration (506 ng/mL) and the highest average concentration over the dosing interval (279 ng/mL), and was associated with a suggestion of improvement in myocardial performance. Exercise performance did not improve in any of the dosing cohorts.

CONCLUSIONS:

Udenafil was well-tolerated at all dosing levels. The 87.5 mg bid cohort achieved the highest plasma drug level and was associated with a suggestion of improvement in myocardial performance. These data suggest that the 87.5 mg bid regimen may be the most appropriate for a Phase III clinical trial.

项与 Mezzion Pharma Co., Ltd. 相关的新闻（医药）

2024-03-01

·PRNewswire

Mezzion Pharmaceuticals Announces Dr. Rahul Rathod of Boston Children's Hospital and Harvard Medical School as the Global Principal Investigator for the Confirmatory Pivotal Phase 3 Trial FUEL-2

FORT LEE, N.J., March 1, 2024 /PRNewswire/ -- Mezzion Pharmaceuticals is a rare disease company conducting the confirmatory pivotal phase 3 clinical trial in Fontan subjects: The Fontan Udenafil Exercise Longitudinal Assessment Trial- 2, or FUEL-2 trial. The company is pleased to announce Dr. Rahul Rathod, a pediatric cardiology specialist and leader with over 20 years of experience at Boston Children's Hospital, as the Global Principal Investigator of FUEL-2. Continue Reading FUEL-2 Dr. Rathod currently serves as the Associate Chair of Cardiology, Director of the Single Ventricle Program, and Director of the Fontan Clinic at Boston Children's Hospital as well as Associate Professor of Pediatrics at Harvard Medical School. He is an internationally recognized medical expert, researcher, and key opinion leader in the single ventricle heart disease space and Fontan circulation—with more than 80 peer-reviewed publications. Dr. Rathod is the Founder and Executive Director of the Fontan Outcomes Registry Using CMR Examinations (FORCE). The FORCE Registry is a tech-enabled research platform dedicated to improving the quality and longevity of life for single ventricle patients by aggregating global Fontan data, advancing cardiac imaging through big data and analytics, and utilizing machine learning to improve workflows and patient outcomes. FORCE is the largest Fontan dataset in the world. As the Global Principal Investigator for FUEL-2, Dr. Rathod will lead the clinical trial, overseeing clinical protocol, conduct, and operations at all study sites. He will also lead the study analysis and contribute to reporting the results to the Food and Drug Administration (FDA). "FUEL-2 represents a pivotal moment in Fontan research pioneering advancements for our patients. This landmark study delves into the potential of udenafil to empower individuals to reclaim vitality in their daily lives," said Dr. Rathod about the trial. "The Fontan population is one with significant medical complexities and unmet needs; this trial offers the promise of tangible solutions and a powerful tool that can redefine the treatment landscape for Fontan patients." "Dr. Rathod is a preeminent expert in Fontan physiology and the ideal clinical leader to serve as the Global Principal Investigator of FUEL-2. Mezzion is very proud and encouraged to have him as our partner as this pivotal clinical trial progresses," said Dr. John Hariadi, Chief Medical Officer and Senior Vice President of Global Regulatory Affairs at Mezzion. Dr. Hariadi recently joined Mezzion from Johnson & Johnson, where he was senior director for global regulatory affairs. He previously served in several senior medical leadership roles at the FDA and the United States Department of Homeland Security. He will serve as Mezzion's primary liaison to the FUEL-2 clinical research organization, study sites, and investigators. FUEL-2 is a Mezzion Pharmaceuticals-sponsored clinical trial investigating the clinical efficacy and safety of udenafil in teenagers 12-18 years of age who have undergone the Fontan procedure. It is poised to be the world's largest Fontan clinical trial and is set to enroll 438 patients globally. Currently, 22 sites in the U.S. are enrolling or will begin enrolling in the coming weeks. The latest site information for FUEL-2 can be found here. Udenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor and was previously studied in some adolescents with Fontan physiology. PDE5 inhibitors relax the blood vessels and may increase the blood flow to the lungs. This may mean higher blood oxygen levels; if so, individuals may be less tired when exercising or during everyday activities. For more information about the study, please visit FUEL2study.com. About Mezzion Pharma Co., Ltd. Mezzion Pharma Co., Ltd. is headquartered in Korea. Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., has an administrative office in Fort Lee, New Jersey. Mezzion Pharma is an innovation-driven pharmaceutical company that is focused on discovering, developing, and commercializing novel therapeutics in the field of rare pediatric diseases. Mezzion Pharma is a publicly listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ). Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Mezzion Pharma's expectations regarding the potential benefits of udenafil; Mezzion Pharma's expectations regarding the anticipated timing of any future clinical trials; Mezzion Pharma's expectations on regulatory submissions for marketing approval of udenafil for the treatment of patients that have undergone the Fontan operation, to improve exercise capacity in the United States, including the timing of these submissions; and Mezzion Pharma's expectations regarding the potential commercial launch of udenafil, including the timing of a potential approval of udenafil. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Mezzion Pharma will need additional funds to finance its operations; Mezzion Pharma's or any of its collaborative partners' ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Mezzion Pharma's or any of its clinical trials will not be successful; Mezzion Pharma's dependence on the success of udenafil; Mezzion Pharma's reliance on third parties for the manufacture of Mezzion Pharma's udenafil and udenafil tablets; possible regulatory developments in the United States and foreign countries; and Mezzion Pharma's ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Mezzion Pharma's most recent filings with the Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risk and uncertainties that may individually or mutually impact the matters herein described, including but not limited to FDA review and approval, product development and acceptance, manufacturing, competition, and/or other factors, which are outside the control of Mezzion Pharma. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Media Contacts: PR Contact – Philicia Thompson, [email protected], 7047749643 Medical Contact – John Hariadi, [email protected], (443) 699-6746 Mezzion Pharma Co. Ltd. Contact – S.I. Noh, [email protected], +82 2 560 8000 SOURCE Mezzion Pharmaceuticals, Inc

临床3期高管变更

2023-12-22

·生物制药小编

医药圈：当命运的齿轮开始转动

许多年前的一笔不起眼的BD＆L，竟是促成将来重大M＆A的关键一环，如赛诺菲以29亿美元收购Provention Bio公司，核心资产来自MacroGenics公司。之前开发的诸多候选药物，要么尘归尘、土归土，要么杳无音讯，要么雷声大、雨点小，一次偶然的BD＆L，竟是促成将来重大M＆A的关键一环，如安进以283亿美元市值收购Horizon公司，核心资产来自River Vision公司。或开发顺位处于较后但未来将成为核心资产的候选药物，竟是促成将来重大M＆A的关键一环，如安进以37亿美元收购ChemoCentryx，核心资产avacopan的历史开发顺位在第4位。没错，当这些偶然的东西走进biotech聚焦视野里的时候，属于它们命运的齿轮开始悄然转动了。1. 被命运之神选中的biotech2. 结语被命运之神选中的biotech核心/领先资产，该司被收购时新闻稿首先或重点提及的资产。历史开发顺位，被收购公司提名候选药物代号或介绍候选药物的次序。几年增长几倍，该司从IPO年份到被收购时的年份，对比收购时的公司价值和IPO发行市值。命运的齿轮开始转动的年数，该司核心/领先资产首次出现的年份至被收购时的年份。资料来自招股书、年报及收购时的新闻稿。下文有点累赘，建议看几个案例后直接跳到文末底下看总结的图表。2017年Horizon公司从River Vision公司获得了核心资产抗IGF-1R 抑制剂teprotumumab，这款药物在Horizon公司的历史开发顺位里排名14。从那以后，命运的齿轮开始转动，5年后，诞生了2022年全球最大的生物医药收购案，283亿美元的公司价值让Horizon实现了11年增长160倍的神迹（粗略年化为59%）。2013年Loxo公司从Array公司获得了核心资产RET 抑制剂LOXO-292，这款药物在Loxo公司的历史开发顺位里排名第3。从那以后，命运的齿轮开始转动，6年后，诞生了80亿美元的收购案，让Loxo实现了5年增长37.6倍的神迹（粗略年化为108%）。插多一句，这笔收购案也牵涉到后来全球首个的第三代BTK抑制剂pirtobrutinib。Pirtobrutinib由Redx公司发现，2016年10月提名为RXC005，当时正处于债务危机的Redx公司急需现金，在2017年7月份不得不以4000万美元将RXC005一次性出售给Loxo公司，后面不会涉及里程碑付款和未来的销售分成。事后回想起来，不知道Redx公司有没有后悔的，把大腿拍断了。2018年Provention Bio公司从MacroGenics公司获得了核心资产抗CD3抗体teplizumab，这款药物在Provention Bio公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，5年后，诞生了29亿美元的收购案，让Provention Bio实现了5年增长20.4倍的神迹（粗略年化为85%）。2016年Biohaven公司从BMS公司获得了核心资产CGRP受体拮抗剂rimegepant，这款药物在Biohaven公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，6年后，诞生了2022年全球生物医药最大的小分子药收购案，116亿美元的公司价值让Biohaven实现了5年增长18.9倍的神迹（粗略年化为82%）。2012年TESARO公司从默沙东获得了核心资产PARP抑制剂niraparib，这款药物在TESARO公司的历史开发顺位里排名第2。从那以后，命运的齿轮开始转动，6年后，诞生了51亿美元的收购案，让TESARO实现了6年增长13.2倍的神迹（粗略年化为56%）。 2014年Zogenix公司从Brabant公司获得了核心资产低剂量芬氟拉明制剂，这款药物在Zogenix公司的历史开发顺位里排名第4。从那以后，命运的齿轮开始转动，8年后，诞生了19亿美元的收购案，让Zogenix实现了12年增长13.2倍的佳绩（粗略年化为25%）。2017年Endocyte公司从ABX公司获得了核心资产PSMA RDC 177Lu-PSMA-617，这款药物在Endocyte公司的历史开发顺位里排名20。从那以后，命运的齿轮开始转动，1年后，诞生了21亿美元的收购案，让曾经濒临溃败的Endocyte实现了7年增长11.6倍的佳绩（粗略年化为44%）。2017年ChemoCentryx公司自主研发的核心资产C5aR拮抗剂avacopan，这款药物在ChemoCentryx公司的历史开发顺位里排名第4。遭受前3款候选药物的开发挫折后，排名老4的avacopan终在2021年获批上市，并在1年后，诞生了37亿美元的收购案，让ChemoCentryx实现了10年增长9.5倍的佳绩（粗略年化为27%）。2013年Ignyta公司从Nerviano Medical Sciences公司获得了核心资产TRK/ROS1抑制剂entrectinib，这款药物在Ignyta公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，4年后，诞生了17亿美元的收购案，让Ignyta实现了3年增长8.7倍的神迹（粗略年化为113%）。2011年FIVE PRIME公司从Galaxy公司获得了核心资产抗FGFR2b抗体bemarituzumab，这款药物在Ignyta公司的历史开发顺位里排名第3。从那以后，命运的齿轮开始转动，10年后，诞生了19亿美元的收购案，让FIVE PRIME实现了8年增长8.1倍的佳绩（粗略年化为32%）。 2011年ZS Pharma公司从UOP公司获得了核心资产钾结合剂硅酸锆复合物ZS-9，这款药物在ZS Pharma公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，4年后，诞生了27亿美元的收购案，让ZS Pharma实现了1年增长6.6倍的神迹（粗略年化不适用）。2007年Hyperion公司从Ucyclyd公司获得了核心资产苯丁酸甘油酯口服液RAVICTI，这款药物在Hyperion公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，8年后，诞生了11亿美元的收购案，让ZS Hyperion实现了3年增长5.9倍的神迹（粗略年化为90%）。2005年CoLucid公司从礼来获得了核心资产5-HT(1F)受体激动剂lasmiditan，这款药物在CoLucid公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，12年后，诞生了9.6亿美元的收购案，让CoLucid实现了2年增长5.3倍的神迹（粗略年化为151%）。2007年Trius公司从Dong-A公司获得了核心资产恶唑烷酮类抗生素tedizolid，这款药物在Trius公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，6年后，诞生了7.07亿美元的收购案，让Trius实现了3年增长5倍的神迹（粗略年化为82%）。2007年Relypsa公司从Ilypsa/安进公司获得了核心资产钾结合剂patiromer，这款药物在Relypsa公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，9年后，诞生了15.3亿美元的收购案，让Relypsa实现了3年增长3.9倍的神迹（粗略年化为70%）。 2009年Durata公司从Vicuron/辉瑞公司获得了核心资产半合成糖肽抗生素dalbavancin，这款药物在Durata公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，5年后，诞生了6.75亿美元的收购案，让Durata实现了2年增长3.4倍的神迹（粗略年化为110%）。2018年Sierra公司从吉利德获得了核心资产JAK1/JAK2抑制剂momelotinib，这款药物在Sierra公司的历史开发顺位里排名第4。从那以后，命运的齿轮开始转动，4年后，诞生了19亿美元的收购案，让曾一度陷于困境的Sierra实现了7年增长2.9倍的佳绩（粗略年化为21%）。2005年Radius公司从Ipsen公司获得了核心资产甲状旁腺激素相关肽abaloparatide，这款药物在Radius公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，17年后，诞生了8.9亿美元的收购案，让Radius实现了8年增长2.8倍的成绩（粗略年化为18%）。2017年Dermira公司从罗氏获得了核心资产IL-13抑制剂lebrikizumab，这款药物在Dermira公司的历史开发顺位里排名第6。从那以后，命运的齿轮开始转动，3年后，诞生了11亿美元的收购案，让Dermira实现了6年增长2.6倍的佳绩（粗略年化为24%）。2011年Kadmon公司从NT Life Sciences公司获得了核心资产ROCK2抑制剂belumosudil，这款药物在Kadmon公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，10年后，诞生了19亿美元的收购案，让Kadmon实现了5年增长2.5倍的佳绩（粗略年化为28%）。 2018年Viela Bio公司从阿斯利康获得了核心资产抗CD19单抗inebilizumab，这款药物在Viela Bio公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，3年后，诞生了30.5亿美元的收购案，让Viela Bio实现了2年增长2.2倍的神迹（粗略年化为79%）。2012年ARMO公司从默沙东获得了核心资产PEG-IL-10 pegilodecakin，这款药物在ARMO公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，6年后，诞生了16亿美元的收购案，让ARMO实现了4个月增长2.2倍的神迹（粗略年化不适用）。2016年Myovant公司从武田获得了核心资产非肽GnRH受体拮抗剂relugolix，这款药物在Myovant公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，6年后，诞生了29亿美元的收购案，让Myovant实现了6年增长2.2倍的佳绩（粗略年化为21%）。2019年CinCor公司从罗氏获得了核心资产醛固酮合成酶抑制剂baxdrostat，这款药物在CinCor公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，4年后，诞生了18亿美元的收购案，让CinCor实现了1年增长2.1倍的佳绩（粗略年化不适用）。2013年Clementia公司从罗氏获得了核心资产RARγ激动剂palovarotene，这款药物在Clementia公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，6年后，诞生了13.1亿美元的收购案，让Clementia实现了5年增长1.9倍的佳绩（粗略年化为24%）。 2016年Dova公司从卫材获得了核心资产TPO受体激动剂avatrombopag，这款药物在Dova公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，3年后，诞生了9.15亿美元的收购案，让Dova实现了2年增长1.2倍的佳绩（粗略年化为48%）。2006年AVEO公司从Kyowa Hakko Kirin公司获得了核心资产泛靶点VEGFR抑制剂tivozanib，这款药物在AVEO公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，16年后，诞生了5.66亿美元的收购案，让AVEO实现了12年增长1.1倍的成绩（粗略年化为6%）。2011年Biotie公司从Synosia/罗氏获得了核心资产A2A受体拮抗剂tozadenant，这款药物在Biotie公司的历史开发顺位里排名第1。从那以后，命运的齿轮开始转动，5年后，诞生了3.63亿美元的收购案，让Biotie实现了7个月增长1倍的成绩（粗略年化不适用）。图1 发生重大M＆A的biotech（丰硕创投整理）结语医药熊市持续了近3年，悲观情绪渗透在每个角落里。有的企业招不到人，因为应聘者怕公司撑不了多久，倒闭了，附近的外卖还没尝尽就得卷铺盖走人了；有的企业裁好多人，因为公司实在没那么多资源去养这么多员工了；有的职员依旧打着这份工，但薪水福利明显不如以前了。医药投资圈也是如此，公募基金经理不得不辞职，才能平息基民的愤懑。私募基金掀起的注销潮，更像是无声的战争，发生的那么剧烈，但在公众里传播的影响力却又如此的低。似乎只有逃离整个医药圈，才有可能与这些悲观情绪绝缘。行业的周期更替、热胀冷缩是一种十分合乎常理的行为，奈何道理大家都懂，仍免不了随波逐流，很难去做些违背人体正常生理的事，比如正遭受着疼痛，却叫喊着舒服。但是往往在最悲观，最不受人关注的时候，蕴藏的机会才有可能是最大的。像本文提到的这批企业，资产出让方若知道自己的资产在多年后能值这么多钱，怎么会如此低价地转让出去。哪怕当时有人穿越回去，千叮咛，万嘱咐地劝诫资产出让方不要卖，或抬高价卖，但当时的环境已经决定了待交易资产就值这个价了，不可能啥亮眼数据都不多，就能卖出高价格的。同样的情况也适用于现在悲观的医药圈，当下的我们好比本文提到的这些在当年不怎么起眼的资产，每当我们多坚持一分，多努力一秒，多往前推进一下，说不定未来我们回忆过往的时候，可以掷地有声地说出，原来那时候命运的齿轮开始转动了。声明：以上内容仅供参考，不构成投资建议。

并购IPO临床3期

2023-08-14

·BioSpace

NEUROBO PHARMACEUTICALS APPOINTS HYUNG HEON KIM AS CHIEF EXECUTIVE OFFICER AND PRESIDENT

BOSTON, Aug. 14, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced the appointment of current Board member, Hyung Heon ("H.H.") Kim, as the Company's Chief Executive Officer and President, effective immediately. Mr. Kim succeeds Joseph Hooker, who served as interim Chief Executive Officer and President since January 2023. Prior to his appointment as Chief Executive Officer and President, Mr. Kim served as the General Counsel and a Senior Vice President of Dong-A ST Co, Ltd. ("Dong-A"), currently the Company's largest stockholder and NeuroBo's partner with respect to its newly in-licensed assets, DA-1241 and DA-1726, potential therapies for nonalcoholic steatohepatitis (NASH), obesity and type 2 diabetes. Mr. Kim has been with Dong-A and its affiliates in various roles since 2012. "H.H.'s deep familiarity with DA-1241 and DA-1726 and strong working relationship with our partner, Dong-A, along with his operational experience, will put NeuroBo in a strong position to advance the clinical development of DA-1241 and DA-1726," said Andrew I. Koven, Chairman of NeuroBo's Board of Directors. "We are also pleased that H.H. will continue to serve on the Board, where, since 2021, he has made significant contributions to the evolution of the Company." Mr. Kim stated, "It is my honor to lead NeuroBo as we continue to advance our diversified pipeline and to position the Company as a leader in the development of treatments for NASH, along with obesity and type 2 diabetes. I look forward to working closely with the NeuroBo team to deliver on the promise of DA-1241 and DA-1726 as we move these assets through their next stages of clinical development, particularly in NASH and obesity and potentially type 2 diabetes, areas with enormous market opportunity." About Hyung Heon Kim Mr. Kim has served as a member of the Company's Board since July 2021. Prior to his appointment as Chief Executive Officer and President of the Company, Mr. Kim was the General Counsel and a Senior Vice President of Dong-A ST and Dong-A Socio Group, a Korean-based group of companies mainly engaged in the research, development, production and sale of pharmaceuticals, medical devices and APIs. Mr. Kim previously served as Executive Director of Dong-A ST from 2018 through 2020 and as Head of International Legal Affairs for Dong-A Socio Holdings Co., Ltd., a Korean-based holdings company for the Dong-A Socio group of companies from 2012 to 2018. During his time at Dong-A ST and Dong-A Socio Holdings, he negotiated many significant transactions, including licensing and investment transactions. Since April 2021, Mr. Kim has served as a director of AnaPath Services GmbH, a private, Swiss-based provider of scientific research and development services. Mr. Kim previously served as legal counsel to SK Energy Co., Ltd. and SK Innovation Co., Ltd. He received his Bachelor of Law degree from Soongshil University in Korea, and obtained his Juris Doctor from Washington University School of Law. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, which promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that acts as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. For more information, please visit . Forward Looking Statements Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, statements regarding the development of NeuroBo's product candidates and the therapeutic potential, timing and nature of clinical trials and potential regulatory approval of NeuroBo's clinical programs and pipeline. Forward-looking statements are usually identified by the use of words, such as "believes," "anticipates," "expects," "intends," "plans," "may," "potential," "will," "could" and similar expressions. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors and risks. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with NeuroBo's ability to execute on its commercial strategy, the success of NeuroBo's new permanent Chief Executive Officer and President, the advancement of NeuroBo's drug development pipeline, in particular through clinical development, NeuroBo's ability to follow the timeline for regulatory submissions and obtain regulatory approvals with respect to the development and commercialization of NeuroBo's current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A, including the impact on future financial and operating results of NeuroBo; the ability to integrate the new product candidates into NeuroBo's business in a timely and cost-efficient manner; the cooperation of NeuroBo's contract manufacturers, clinical study partners and others involved in the development of NeuroBo's current and future product candidates; costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; changes in applicable laws or regulations; effects of changes to NeuroBo's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in NeuroBo's filings with the SEC; and other factors discussed in the "Risk Factors" section of NeuroBo's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 30, 2023. In addition, the forward-looking statements included in this press release represent NeuroBo's views as of the date hereof. NeuroBo anticipates that subsequent events and developments will cause its views to change. However, while NeuroBo may elect to update these forward-looking statements at some point in the future, NeuroBo specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NeuroBo's views as of any date subsequent to the date hereof. Contacts Investors & Media: Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com Company Codes: NASDAQ-NMS:NRBO

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