IRVINE, Calif. - Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN) announced positive outcomes from an early-stage clinical trial involving islet transplant recipients treated with tegoprubart, a novel immunosuppressive drug. The study, conducted by the University of Chicago Medicine's Transplantation Institute, showed that two out of three participants achieved insulin independence with stable blood glucose levels post-transplant.
The research, presented at the 5th IPITA/HSCI/Breakthrough T1D Stem Cells Summit, suggests that tegoprubart could be a less toxic alternative to tacrolimus, the current standard of care in transplant immunosuppression. Islet engraftment in subjects treated with tegoprubart was estimated to be three to five times higher than in those receiving tacrolimus-based regimens.
Tegoprubart is an investigational anti-CD40L monoclonal antibody therapy and is part of the immunosuppression regimen used in the trial. The study's participants, all with type 1 diabetes, received islet transplants along with induction therapy, mycophenolate mofetil (MMF), and tegoprubart administered every third week. The first two subjects became insulin independent at approximately three and six months post-transplant, respectively. The third subject, who recently underwent transplantation, has reduced insulin usage and is on the path to insulin independence.
The treatment was generally well tolerated, with no unexpected adverse events or severe hypoglycemic episodes reported. The first participant, a 42-year-old female, achieved insulin independence approximately two weeks after a second islet transplantation and maintained improved hemoglobin A1C levels. The second participant, a 30-year-old female, ceased insulin use four weeks following her transplant.
Eledon Pharmaceuticals provided tegoprubart for the investigator-led trial and is evaluating the drug's efficacy in preventing transplant rejection. Funding for the study includes grants from Breakthrough T1D and The Cure Alliance.
This development marks a significant step in the management of type 1 diabetes, potentially offering a functional cure for the condition. The news is based on a press release statement from Eledon Pharmaceuticals.
In other recent news, Eledon Pharmaceuticals has successfully completed an equity sale, generating gross proceeds of approximately $4 million. This transaction is part of Eledon's ongoing financial activities aimed at capital growth. The company also initiated a significant agreement with Guggenheim Securities, allowing for a common stock sale of up to $75 million. This arrangement provides Eledon with the opportunity to define the parameters of the sale, including duration, daily volume limits, and a minimum price threshold.
Eledon has also been making strides in its corporate governance, expanding its employee incentive plan to 17.96 million shares, and electing Dr. Steven Perrin and Dr. June Lee as Class I Directors. On the clinical front, Eledon continues to advance trials for tegoprubart, a potential treatment for organ rejection in kidney transplant recipients, which led H.C. Wainwright to maintain a Buy rating for the company's shares. Lastly, Eledon secured approximately $50 million in gross proceeds via a private investment in public equity financing arrangement. These are among the recent developments at Eledon Pharmaceuticals.
InvestingPro Insights
The positive clinical trial results for Eledon Pharmaceuticals' (NASDAQ: ELDN) tegoprubart have been reflected in the company's recent stock performance. According to InvestingPro data, ELDN has shown a strong return of 35.34% over the last month and an impressive 111.4% over the past year. This upward trajectory aligns with the promising outcomes of the early-stage trial for islet transplant recipients.
Despite the encouraging clinical progress, it's important to note that Eledon is still in the development stage. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year, which is typical for biotech firms investing heavily in research and development. This is further supported by the InvestingPro data showing an adjusted operating income of -$46.91 million for the last twelve months as of Q2 2023.
Another relevant InvestingPro Tip highlights that Eledon holds more cash than debt on its balance sheet. This financial position could be crucial for funding further clinical trials and potential commercialization efforts for tegoprubart.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Eledon Pharmaceuticals, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.