26 Apr Angion Receives Support to Develop Drug Candidate for a Scarring Form of Kidney Disease, FSGS
MedicalResearch.com Interview with:
Dr. Venkatesan
Dr. Jay Venkatesan MD
President and CEO of Angion
Dr. Venkatesan discusses the recent announcement that ANGION, has received DOD funding for the study of ANG-3070, in treatment of CKD caused by focal segmental glomerulosclerosis,
MedicalResearch.com: What is the background for this announcement? Would you tell us a little about focal segmental glomerulosclerosis (FSGS)? How does ANG-3070 work to prevent kidney scarring?
Response: Angion has received a follow-on grant from the Department of Defense (DoD) for $4.76 million in support of the development of ANG-3070, our drug candidate for a form of chronic kidney disease known as focal segmental glomerulosclerosis (FSGS). This funding will allow us to expand our proof-of-concept data for ANG-3070 as a potential anti-fibrotic agent for slowing the progression of FSGS.
FSGS is a serious kidney disorder characterized by progressive scarring of the glomeruli, the filtering units of the kidney. There are approximately 80,000 cases of FSGS in the U.S. and Europe, involving both children and young adults. If uncontrolled, FSGS can lead to kidney failure, which may lead to the need for dialysis or a kidney transplant. No therapies exist that treat the underlying cause of FSGS. Therapies such as corticosteroids, immunosuppressants or diuretics are used, but are mainly supportive and a large proportion of patients progress to end-stage renal disease over a 5-10 year period of time.
ANG-3070 is an oral small molecule that selectively inhibits molecular pathways associated with scarring or fibrosis in the kidney and other organs. Our current preclinical study in collaboration with NEPTUNE aims to identify the “signalosome,” or human disease and drug response profile based on the genes, networks and pathways that correlate with the therapeutic activity of ANG-3070 in FSGS. Ultimately, this collaboration will allow us to develop a precision medicine approach to identify and treat patients in whom ANG-3070 is most likely to block the pathways causing FSGS.
MedicalResearch.com: What are the main findings of the Phase 2/Phase 3 studies of ANG-3777 in AKI in cardiac surgery patients and renal transplant patients? How does ANG-3777 differ from ANG-3070?
Response: Angion previously completed a Phase 2 trial of ANG-3777 in kidney transplant patients that showed patients receiving ANG-3777 within 36 hours of the transplant demonstrated an improvement in urine production and overall kidney function. There was also a measurable reduction in the duration of delayed graft function, indicating that the transplanted kidney gained function and started working earlier than it may have otherwise. We are conducting a Phase 3 registration trial of ANG-3777 in transplant patients to confirm these earlier results in anticipation of filing for approval to prevent delayed graft function. We are also conducting a Phase 2 trial in cardiac surgery patients at risk of developing acute kidney injury to determine whether treatment with ANG-3777 can reduce the incidence and severity of acute kidney injury in these patients.
The mechanism of action differs for ANG-3777 and ANG-3070. ANG-3777 is a small molecule that mimics HGF, a protein that prevents cell death, activates self-repair and stimulates regeneration following organ injury. ANG-3777 augments the body’s natural pathways to drive a more substantial and faster healing response. ANG-3070 inhibits specific enzymes to block pathways that lead to fibrosis or scarring in organs.
MedicalResearch.com: Does ANG-3070 potentially work in other sclerosing conditions i.e. pulmonary fibrosis or scleroderma?
Response: Yes, ANG-3070 has shown anti-fibrotic activity in preclinical models of fibrotic kidney disease and pulmonary fibrosis. We are continuing to study ANG-3070 in other models of sclerosis and fibrosis as we plan for initiation of P2 proof-of-concept studies starting in 2020.
MedicalResearch.com: What should readers take away from your report?
Response: The ANG-3070 biomarker driven approach is critical because of the complex nature of FSGS and other fibrotic diseases and the unpredictable response rates to available therapies. A precision medicine method is key to targeting patients most likely to benefit from this treatment, and we are hopeful that ANG-3070 will be a first in-class anti-fibrotic for the treatment of FSGS and other chronic kidney diseases.
MedicalResearch.com: Is there anything else you would like to add?
Response: Over the course of the company’s existence, we have been honored to receive approximately $75 million in grants from the NIH, DoD and other government entities to further advance our research and clinical programs. We remain committed to bringing ANG-3777 to market and to rapidly advancing ANG-3070 to the clinic. Our mission is to save lives and improve the quality of life for patients by accelerating the recovery process in acutely injured organs and preventing or reversing fibrosis associated with chronic organ injury.
Citation:
Announces partnership with Nephrotic Syndrome Study Network (NEPTUNE)
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Last Updated on April 26, 2019 by Marie Benz MD FAAD