Invopressin

REDWOOD CITY, Calif.--( BUSINESS WIRE )--Ocelot Bio, Inc., a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics to treat complications of end-stage liver disease (ESLD), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of ascites due to all etiologies except cancer. “The FDA granting Orphan Drug Designation for OCE-205 in ascites is validation of the tremendous need for improved therapies offering novel approaches for patients and supports our clinical focus on this important indication,” said Lise Kjems, M.D., Ph.D., chief medical officer at Ocelot Bio. “This milestone serves as a catalyst as we work with patients, healthcare professionals and health authorities to pave a brighter path forward for these patients who have limited treatment options. We are well positioned to further advance our clinical development program for OCE-205 and look forward to progressing this program in ascites.” Ascites is the abnormal accumulation of fluid within the peritoneal cavity of the abdomen and the hallmark of progression into the decompensated phase of cirrhosis. Data suggest that approximately 400,000 people live with ascites, with 60,000 refractory to standard-of-care treatment and who require much more aggressive treatment approaches. 1,2 Current treatments for ascites are limited, are often invasive procedures and may come with significant risks and burden for patients, underscoring the critical need for novel advancements that improve outcomes for those suffering from this devastating condition. Ocelot Bio plans to initiate clinical studies of OCE-205 in refractory ascites in 2024. The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides Ocelot Bio certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication. This is the second Orphan Drug Designation for OCE-205, which previously received the designation in hepatorenal syndrome. About OCE-205 Ocelot Bio’s lead asset, OCE-205, is a therapeutic peptide with a differentiated mechanism of action that has potential for improving outcomes for patients with complications of end-stage liver disease (ESLD). OCE-205’s innovation emanates from its design as a mixed agonist-antagonist peptide selective for the vasopressin 1a (V1a) receptor with no vasopressin 2 (v2) receptor activity at drug concentrations well above those used in treating ESLD. By virtue of its mixed V1a agonist/antagonist activity, OCE-205 treatment is designed to relieve portal hypertension while offering a capped maximal efficacy that avoids excessive vasoconstriction seen with full agonists, that leads to ischemic injury and potentially other serious adverse events such as respiratory failure. By eliminating V2 activity, OCE-205 treatment is designed to avoid fluid retention and overload. A Phase 2 clinical trial has completed enrollment to evaluate OCE-205 for the treatment of hepatorenal syndrome with acute kidney injury (HRS-AKI) ( NCT05309200 ), and clinical studies for ascites are expected to initiate in 2024. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for OCE-205 in the treatment of hepatorenal syndrome in 2022 and in ascites in 2023. About Ocelot Bio Ocelot Bio is a clinical-stage biopharmaceutical company focused on the development of innovative therapeutics designed to significantly improve outcomes for patients with liver disease. The company’s lead clinical candidate, OCE-205, is a peptide therapeutic with a mechanism of action designed to selectively target complications of portal hypertension, such as hepatorenal syndrome with acute kidney injury (HRS-AKI) and ascites, serious and life-threatening consequences of end-stage liver disease (ESLD). The company was founded by leading experts in peptide therapeutic development and is backed by a strong syndicate of investors including Venrock, RA Capital Management and Vivo Capital. For more information, visit www.ocelotbio.com . References 1 Siqueira F, et al. Gastroenterol Hepatol (N Y) . 2009;5(9):647-656. 2 Orman, et al. JAMA Netw Open . 2019;2;2(10):e1913673.

None Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please submit the good news—or the bad—from your shop, and we will feature it here at the end of each week. Oracle Former Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma is joining software giant Oracle. Verma will be senior vice president and general manager of Oracle Life Sciences, the company’s clinical trials business. She will lead the Oracle Life Sciences and Oracle Cerner Enviza lines of business. Oracle extended its reach into the healthcare industry with its $28 billion acquisition of medical records software company Cerner last year. As administrator for the federal CMS during the Trump administration, Verma was responsible for 6,000 employees and 100,000 contractors as well as coverage for 145 million beneficiaries. During her tenure at CMS, Verma pushed forward several major interoperability initiatives as well as policies to advance value-based care and price transparency, while reducing drug prices and regulations through the Patients over Paperwork Initiative.  Most recently, she served as a senior adviser to private equity firms Cressy & Co. and TPG. “Seema has a proven track record of success in both public and private sector healthcare,” said Mike Sicilia, executive vice president of Oracle Global Industries. “Because of this, she has a unique understanding of how to bring together those on the cutting edge of innovation and those in charge of regulation to help our customers make critical medical breakthroughs and bring new therapies to market.” Children's Hospital Los Angeles Children's Hospital Los Angeles tapped Conrad Band as its permanent senior vice president and chief information officer. Band has held the CIO role in an interim capacity since May 2021. He will continue providing vision, strategy and direction for information systems and technology throughout the CHLA enterprise. He oversees all CHLA Information Services (IS) teams—IT Operations; Infrastructure; Technology Training and Adoption; Information Security and Applications—as well as key vendors that provide technology solutions for CHLA. Band joined CHLA in 2017 as chief information security officer. He took on the interim CIO role in the middle of the COVID-19 pandemic, and under his leadership the IS team has been able to support the organization in innovative and collaborative new ways, including remote work and expanded telehealth capabilities, the hospital said. Lehigh Valley Orthopedic Institute Thomas Graham, M.D., a renowned orthopedic hand surgeon, healthcare executive, author, inventor and entrepreneur, has been named the first physician in chief of Lehigh Valley Orthopedic Institute. Graham has served as the hand surgery consultant, team physician or medical director for the PGA Tour and numerous professional teams in the NFL, MLB, NHL and NBA. He has cared for more than 2,000 professional athletes. As physician in chief, Graham will lead the development of new programs, services and technology within the Orthopedic Institute while continuing to provide patient care. Lehigh Valley Orthopedic Institute comprises more than 200 providers at 100 practice and rehabilitation locations. Orthopedic Institute surgeons perform more than 17,000 procedures annually, three times as many joint replacements and twice as many sports medicine procedures than others in the regions LVHN serves. Virta Digital diabetes company Virta tapped Siobhan Nolan Mangini to join its board of directors. Mangini brings more than two decades of healthcare experience to her role. Currently, she serves as president and chief financial officer at NGM Biopharmaceuticals, a biotech company focused on developing immuno-oncology treatments. Before that, Mangini was the president and CFO of healthcare navigation company Castlight Health and held healthcare roles at Bain Consulting and the Kaiser Family Foundation.  With a breadth of experience scaling both private and public healthcare companies, Mangini will be an invaluable asset to guide Virta through its next phase of growth and in its quest to reach its eventual goal of reversing diabetes in 100 million people, the company said. > Swiss biotech company Engimmune Therapeutics AG announced Lars Nieba, Ph.D., as its new chief executive officer. Dr. Søren Mouritsen, co-founder and previous CEO, steps down in a planned transition. > CVS Health named a veteran insurance executive to lead its Aetna unit. Brian Kane will join CVS as executive vice president and president of Aetna effective Sept. 1. > Craig Johnson was named executive vice president and COO of Chicago-based Northwestern Medicine. He has served as Northwestern University's executive vice president since 2018.  > Tabula Rasa HealthCare appointed Brian Adams as president and CEO. Adams was serving as TRHC's interim CEO since September 2022 and previously served as the company's co-president and chief financial officer. The company also announced that Richard W. Rew II has joined as chief legal officer and corporate secretary. > AccessHope tapped Joy Kincaid to serve as the company's chief product officer.  > Lisa Joldersma is joining Avalere Health as its new strategic adviser. Joldersma will support the policy practice by bringing deep expertise in Medicare, commercial and employer-based insurance, and state policy issues, according to the company. > Biotech company Abivax SA appointed Michael Ferguson as new chief commercial officer. > Former FDA research leader Nicholas Kozauer, M.D., has joined Biohaven's executive leadership team as senior vice president for clinical development and regulatory strategy.    > LexisNexis Risk Solutions, a provider of data and analytics, hired Adam Mariano as the new president and general manager of its healthcare division.  > Digital health lawyer Andrea Linna joins Wilson Sonsini Goodrich & Rosati's regulatory department as a partner. She will be a part of the firm’s digital health industry group and its FDA regulatory, healthcare and consumer products practice. > Nobi, a provider of innovative age-tech solutions, added Sarah Thomas, one of the U.S.’ leading age-tech experts, to its board of directors. > Lise Kjems, M.D., Ph.D., has jumped over to clinical-stage biopharmaceutical company Ocelot Bio to serve as its new chief medical officer. Kjems will oversee the clinical development efforts for Ocelot Bio’s lead candidate, OCE-205, for the treatment of hepatorenal syndrome with acute kidney injury and ascites.