Eledon Drug Shows Safety In Early Organ Transplant Study

 Tuesday, Eledon Pharmaceuticals Inc 

ELDN+7.08%

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 announced that the first participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with tegoprubart for the prevention of pancreatic islet cell transplant rejection in type 1 diabetes patients.

The company also reported updated data from its ongoing Phase 1b trial as of April 2024 from 13 participants, demonstrating that tegoprubart is generally safe and well-tolerated and supports tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation.

Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – measured above 60 mL/min/1.73m2 at all reported time points after day 30.

Two subjects completed 12 months on therapy post-transplant and both demonstrated mean eGFRs above 90 mL/min/1.73m2 at one year.

To date, three subjects discontinued the study because of hair loss and fatigue, viral infection, and rejection, respectively. 

There have been no cases of graft loss or death. 

Eledon is currently conducting a Phase 1b trial, the Phase 2 BESTOW trial, and a Long-Term Safety and Efficacy extension study to evaluate tegoprubart for the prevention of organ rejection in kidney transplant patients.

Concurrently, Eledon Pharmaceuticals announced a private placement of approximately $50 million, offering 13.1 million shares at $2.37 per share and pre-funded warrants at $2.369 per underlying share, which are exercisable to purchase 7.99 million shares.

HC Wainwright suggests that islet cell transplantation could be a promising way to reverse type 1 diabetes by restoring metabolic control without relying on insulin injections. The analyst highlights tegopruibart’s potential to decrease or replace intensive anti-rejection drugs without causing side effects. 

HC Wainwright reiterates the Buy rating, and with increased confidence in tegoprubart’s probability of advancement into a pivotal study, it has raised the price target from $13 to $16.

The analyst continues to look for the potential signing of a licensing collaboration agreement, including an upfront payment worth up to $100 million, for further development and commercialization of tegoprubart around the 2025 timeframe as a future catalyst.

https://www.benzinga.com/analyst-ratings/analyst-color/24/05/38680636/nano-cap-eledon-pharmaceuticals-investigational-drug-shows-safety-in-early-organ-tr