Since Eledon Pharmaceuticals Inc.’s Phase 2 kidney trial failed to meet its primary endpoint, sending shares down nearly 50%, the Irvine-based biotech company is making progress in its other areas of research.
Eledon last week announced updated data from an islet cell transplant study that showed a majority of patients achieving insulin independence.
The study, conducted at the University of Chicago Medicine Transplant Institute, evaluated Eledon’s lead drug candidate tegoprubart for use in preventing rejection in a minimally invasive procedure that helps restore insulin production in patients with Type 1 Diabetes.
Of the 12 patients, 10 were able to stop using insulin and displayed normal blood sugar levels four weeks post-islet cell transplant.
“The fact that these patients are no longer on insulin is completely real and it’s available today from a study perspective,” Chief Executive Dr. David-Alexandre “DA” Gros told the Business Journal.
Initiating Second T1D Study This Year
Gros said that the patients prior to the study experience dangerously low blood sugar, which can cause unconsciousness, seizures and in some instances, death.
He described people who have passed out in their homes or crashed their cars mid-driving due to their blood sugar dropping.
“This isn’t because people aren’t taking care of themselves or not taking insulin,” Gros said.
“They just have a very hard to control form of diabetes.”
Within the study, none of the 12 patients experienced what’s called a severe hypoglycemic event post-transplant on tegoprubart.
The trial was funded by Breakthrough T1D, the world’s largest nonprofit funder of T1D research, with initial support from The Cure Alliance.
Breakthrough T1D is now funding a second trial this year studying patients with high-risk diabetes and chronic kidney disease.
One side effect of diabetes over time is kidney dysfunction. The current standard of care tacrolimus, which Eledon aims to replace, is known to be a kidney toxin, according to Gros.
“You wouldn’t want to do a transplant on them and give them tacrolimus because then you might destroy the remaining kidney function,” he said. “So, we’re going to look at a population that is in that category where we could provide a solution because, to date, we haven’t seen any kidney impact with our drug.”
Phase 2 Trial Failed to Meet Clinical Endpoint
Last November, the company announced results from its global Phase 2 Bestow clinical trial, which evaluated tegoprubart for the prevention of kidney transplant rejection.
Tegoprubart did not demonstrate superior kidney function compared to tacrolimus, causing shares to fall in half to $2.05 in the trading session following the announcement and hit a 52-week low of $1.35 on Nov. 21. Since then, the shares have rebounded to $2.76 apiece with a market cap of $218 million (Nasdaq: ELDN).
Despite the bad news, the investors expressed confidence as the company raised $53.6 million in a public offering, which will allow the company to launch a Phase 3 study and obtain approval, according to officials.
Eledon plans to initiate a Phase 3 trial this year after meeting with the FDA to discuss the path to approval, Gros said.
“Once we can agree with the agency and we have a plan, we can begin to launch our regulatory path studies,” he said.
