Angion Biomedica Nears End of Clinical Trials for Organ-Repairing Molecule
Repairing a damaged organ in order to allow an individual to have a healthier life, as well as a greater quality of life, could soon be a reality as New York-based Angion Biomedica Corp. moves toward completing clinical trials of its lead asset.
The company is developing ANG-3777, a small molecule harnessing the effects of Hepatocyte growth factor (HGF). HGF is an organ repair protein best known for providing the liver with a unique ability to regenerate itself. Angion research has noted that HGF also triggers extensive self-repair pathways within the kidneys, liver, heart, brain and lungs. Angion researchers discovered a small molecule that allows the body to drive a healing response.
Angion Chief Executive Officer Jay Venkatesan, who joined the company last year, said in a typical case when a patient has an injured organ, the body will attempt to repair itself. Angion’s lead candidate operates along the HGF pathway and “drives some self-repair along the natural pathways,” he told BioSpace in an exclusive interview. Currently, Venkatesan said there is no therapeutic on the market that delivers the same effect. Angion has begun its research with ANG-3777 in the kidney, and if it continues to demonstrate efficacy and safety in the late-stage trial, Venkatesan said the company will likely explore its uses in other organs.
“Right now it seems to be a ubiquitous path,” Venkatesan said. That means that the Angion candidate could drive a healing response in almost any organ in the body. “It’s interesting to see what the limits are.”
ANG-3777 is in two studies, a Phase II and a Phase III. The late-stage study concerns patients who have undergone a kidney transplant. The trial will continue a Phase II study of kidney transplant patients who had low or no urine output post-transplant. In the Phase II trial, patients were provided three doses of ANG-3777 within three days of the transplant. Over an assessed period of 28 days, the patients demonstrated increased urine output, lowered serum creatinine and improved renal function. Additionally, the results showed that the dosing reduced the need for dialysis. The Phase II observations, which Venkatesan said was meant to be a proof-of-concept study, will be confirmed in the Phase III GIFT (Graft Improvement Following Transplantation) study. In the late-stage trial, patients will be provided three doses of ANG-3777 or placebo within 30 hours of transplant. The trial will include about 300 people. Data from this trial is expected in the first quarter of 2020.
The data was compelling enough for Vivek Ramaswamy’s Sinovant to license ANG-3777 for potential commercialization in the People's Republic of China, Hong Kong, Macau and Taiwan. Sinovant will conduct clinical trials of the asset, which it dubbed BB3, in China.
Angion is also conducting a mid-stage trial in cardiac patients. Data from this trial is expected in the second quarter next year. Angion plans to initiate a heart attack study as well in order to improve measure of heart function following catheterization.
ANG-3777 isn’t the only exciting asset in Angion’s pipeline. Last week the company secured a $4.76 million Department of Defense follow-on grant for ANG-3070, the company’s precision drug candidate for the treatment of fibrotic diseases. Specifically, ANG-3070 is in development for primary focal segmental glomerulosclerosis (FSGS), a form of chronic kidney disease.
The DoD grant supports a previous $2.2 million grant that was used to establish preclinical proof-of-concept for ANG-3070 as an anti-fibrotic agent with the potential to delay or halt the progression of FSGS. Angion partnered with Nephrotic Syndrome Study Network to advance the study of ANG-3070. The study data is expected to support the completion of an Investigational New Drug Application and launch human studies of ANG-3070 for FGS and other fibrotic conditions. Venkatesan anticipates the potential start of Phase I trials in the third quarter of this year and the beginning of efficacy studies in 2020.
As Angion pushes forward with the development of its candidates, the company is also pushing forward in growth. Venkatesan said the company will likely double in headcount by the end of the year.
“I’ve been happy with the progress we’re making with 3777 and pushing 3070 into the clinic. Once that gets into the clinic, there’s a lot of places we can go with that,” Venkatesan said.