ANG-3777 shows improved short- and long-term graft function with a positive safety profile in a Phase 2 study
New data support company’s ongoing Phase 3 study
UNIONDALE, N.Y., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (Angion), a clinical stage biopharmaceutical company developing a first-in-class therapy to treat acute kidney injuries, presented positive long-term data from its Phase 2 clinical trial of ANG-3777 in kidney transplant patients with acute kidney injury associated with delayed graft function. The data were presented as a late-breaking abstract at the American Society of Nephrology Kidney Week 2019 Annual Meeting (ASN19) in Washington, D.C.
The Phase 2 data indicate improved short- and long-term graft function, as measured by 12‑month eGFR, with no evidence of increased adverse events as compared with the placebo arm patients. These long-term results are in line with previously reported short-term data from the study showing improved clinical outcomes in patients when ANG-3777 was given within 36 hours of a kidney transplant.
“ANG-3777 demonstrated long-term improvement in kidney function in kidney transplant patients with acute kidney injury associated with delayed graft function,” said John Neylan, M.D., Senior VP and Chief Medical Officer. “The clinical data collected to date for ANG-3777 support our belief ANG-3777 has the potential to help patients who don’t currently have effective therapeutic options to address this serious condition and improve the function of transplanted kidneys. The ongoing Phase 3 study of ANG-3777 in these patients is more than half enrolled and we expect to report data in the second half of 2020.”
Key data presented at ASN19 included:
- Urine output was similar between groups at baseline, after which patients in the ANG‑3777 arm showed greater improvement in urine output than placebo on 10 of the next 13 days.
- Patients in the ANG-3777 arm were more likely to achieve the primary endpoint of the study, a clinically meaningful increase in urine output (≥1200cc urine/24 hours by 28 Days).
- Estimated glomerular filtration rate (eGFR) was higher for the ANG-3777 arm at day 14, day 28, month 6, and month 12.
- There were no transplant failures in the ANG-3777 arm versus two transplant failures in the placebo arm.
- Patients in the ANG-3777 arm had fewer hospital days after transplantation.
- Patients in the ANG-3777 arm had fewer dialysis sessions and shorter duration of dialysis in the first month after transplantation.
- The overall incidence of treatment emergent serious adverse events (TESAEs) was equivalent between the arms. Physicians treating the patients in the Phase II trial did not attribute any TESAEs to ANG-3777.
“The importance of a well-functioning allograft as demonstrated by an optimized estimated glomerular filtration rate (eGFR) is clearly established in predicting positive, long-term outcomes for kidney transplant patients,” said Matthew Weir, M.D., Professor of Medicine and Director of the Division of Nephrology at the University of Maryland. “To achieve eGFR levels superior to placebo at time points as far as one year after transplant is especially exciting.”
A copy of the Phase II data presented at ASN19 is available in the Science Publications section of the company’s website.
About ANG-3777
ANG-3777 is a small molecule hepatocyte growth factor (HGF) mimetic. Its development is grounded in decades of research investigating the role of the HGF/c-Met pathway in organ repair. When an organ is injured, HGF expression peaks around two hours but c-Met receptor expression peaks around 24-36 hours, creating a mismatch between HGF and c-Met potentially resulting in sub-optimal rates of organ self-repair. ANG-3777 is designed to address this challenging mismatch, supplementing endogenous HGF during peak c-MET receptor expression. ANG-3777 is currently in a Phase III trial for the treatment of acute kidney injury associated with delayed graft function and a Phase II trial for acute kidney injury associated with cardiac surgery.
About Delayed Graft Function
Delayed graft function is a condition resulting from acute kidney injury potentially occurring following kidney transplantation. Delayed graft function is defined by the need for dialysis within the first week after transplantation and is associated with poor short-term and long-term patient outcomes. Patients who experience delayed graft function have a reduction in transplant survival. There are no therapeutics approved to address delayed graft function resulting from acute kidney injury.
About Angion Biomedica Corp.
Angion is a clinical stage biopharmaceutical company focused on acute kidney injury, a potentially life-threatening condition without therapeutic options. The company’s lead clinical asset, ANG-3777, is engineered to activate the HGF/c-Met pathway, an important mechanism in organ repair. Enrollment is ongoing in a placebo-controlled Phase 3 trial examining the efficacy of ANG-3777 in reducing the severity of delayed graft function after kidney transplant. For further information, please visit www.angion.com.
Contacts
Investor Contact
Daniel Ferry
LifeSci Advisors
617-535-7746
daniel@lifesciadvisors.com
Media Contact
Cherilyn Cecchini, M.D.
LifeSci Public Relations
646-876-5196
ccecchini@lifescipublicrelations.com