SAN DIEGO--(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 the close of a $36 million Series A financing led by RA Capital Management, Venrock and Vivo Capital and the appointment of Katherine Vega Stultz, an experienced pharmaceutical and biotech executive, as president and chief executive officer. Ocelot Bio recently received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND) application and will initiate a Phase 2 trial with lead candidate OCE-205 for the treatment of hepatorenal syndrome with acute kidney injury (HRS-AKI).
Ocelot Bio’s lead clinical candidate, OCE-205, is a peptide therapeutic with a mechanism of action designed to selectively target complications of portal hypertension that is being explored first in HRS-AKI. HRS-AKI is a serious and rapidly progressive consequence of end-stage liver disease (ESLD) that leads to acute renal failure and often death. HRS-AKI impacts up to an estimated 75,000 individuals in the United States per year and is currently associated with a mortality rate of more than 50 percent at 90 days following diagnosis.i There has been no therapeutic drug innovation for HRS-AKI in over two decades and, currently, there are no FDA-approved treatments for the disease. Preclinical research and Phase 1 data in healthy volunteers suggest that OCE-205 has the potential to become a best-in-class clinical therapeutic to improve outcomes for ESLD patients who are at risk of renal failure or death from HRS-AKI.
The company also announced today the appointment of Katherine Vega Stultz as president and chief executive officer taking over from founding CEO Geoff Harris. Katherine is an entrepreneurially driven corporate leader with broad enterprise experience serving in leadership roles across the operations, clinical development and commercial functions of leading global healthcare companies, including Celgene, Eli Lilly & Company and, most recently, as the chief operating officer at Graphite Bio. She brings to the role a proven track record of success in building brands that have generated over $1B in annual revenue.
“I am thrilled to join Ocelot Bio at this critical time with the near-term initiation of OCE-205’s Phase 2 study, representing the first therapeutic innovation in several decades for individuals with HRS-AKI and driving toward better serving these patients who are in dire need of an effective therapy,” said Katherine Vega Stultz, president and chief executive officer at Ocelot Bio. “The preclinical and clinical work completed to-date by the founding team is noteworthy and demonstrates the significant promise for this compound as a potential best-in-class therapy for individuals with complications of end-stage liver disease for whom there are currently no FDA-approved treatment options.”
In addition to enabling the IND clearance of OCE-205 from the U.S. FDA, the Series A financing will support Ocelot Bio’s progress in advancing OCE-205 into other indications such as ascites.
“Together with RA and Vivo, Venrock is pleased to support the expansion of Ocelot Bio’s leadership team and the rapid advancement of the company’s clinical pipeline, which has substantial potential in its first indication and potential future indications,” said Camille Samuels, partner at Venrock. “Katherine’s broad leadership background makes her an ideal choice to lead the Ocelot Bio team into this next, critical phase in OCE-205’s path toward commercialization.”
Hepatorenal syndrome with acute kidney injury (HRS-AKI) is a rapidly progressive complication of end-stage liver disease (ESLD) that can lead to renal failure and, in approximately half of patients, death.iii,iv It is estimated to impact as many as 75,000 patients in the United States each year,v,vi and the incidence is expected to increase as the prevalence of liver diseases increases. Management of HRS-AKI is largely unchanged over past several decades, and there is currently no FDA-approved treatment. Preclinical research and Phase 1 data in healthy volunteers suggest that OCE-205, Ocelot’s lead therapeutic candidate, has the potential to improve outcomes for patients with HRS-AKI by reversing renal failure and prolonging survival to enable more patients to successfully undergo liver transplantation with fewer needing combined liver and kidney transplantation.
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), a serious and life-threatening consequence of end-stage liver disease (ESLD). Ocelot Bio plans to initiate a Phase 2 clinical trial of OCE-205 in the first half of 2022 in HRS-AKI, for which there has been no therapeutic drug innovation in over two decades. The company was founded by leading experts in peptide therapeutic development and is backed by a strong syndicate of investors including Venrock Ventures, RA Capital Management and Vivo Capital. For more information, visit www.ocelotbio.com.
i Allegretti, Andrew S., et al. “Prognosis of Acute Kidney Injury and Hepatorenal Syndrome in Patients with Cirrhosis: A Prospective Cohort Study.” International Journal of Nephrology, vol. 2015, 2015, pp. 1–9., https://doi.org/10.1155/2015/108139.
ii Boyer, Thomas D., et al. “Terlipressin plus Albumin Is More Effective than Albumin Alone in Improving Renal Function in Patients with Cirrhosis and Hepatorenal Syndrome Type 1.” Gastroenterology, vol. 150, no. 7, 2016, https://doi.org/10.1053/j.gastro.2016.02.026.
iii Wong, Florence, et al. “Terlipressin plus Albumin for the Treatment of Type 1 Hepatorenal Syndrome.” New England Journal of Medicine, vol. 384, no. 9, 2021, pp. 818–828., https://doi.org/10.1056/nejmoa2008290.
iv Sepanlou, Sadaf G, et al. “The Global, Regional, and National Burden of Cirrhosis by Cause in 195 Countries and Territories, 1990–2017: A Systematic Analysis for the Global Burden of Disease Study 2017.” The Lancet Gastroenterology & Hepatology, vol. 5, no. 3, 2020, pp. 245–266., https://doi.org/10.1016/s2468-1253(19)30349-8.
v Ginès, Pere, et al. “Hepatorenal Syndrome.” Nature Reviews Disease Primers, vol. 4, no. 1, 2018, https://doi.org/10.1038/s41572-018-0022-7.