Eledon’s ALS Antibody AT-1501 Renamed Tegoprubart
The investigational antibody therapy for amyotrophic lateral sclerosis (ALS), AT-1501, will now be called tegoprubart, its maker, Eledon Pharmaceuticals, has announced.
The change comes after the United States Adopted Names (USAN) Council selected tegoprubart as the unique generic, or nonproprietary, name for the therapy candidate.
The company also announced that its Phase 2 clinical trial (NCT04322149) testing tegoprubart has completed patient enrollment for all four dosing groups. Top-line data from the trial is expected in the second quarter of this year.
“We look forward to providing clinical updates from each of our four programs this year, highlighting the broad therapeutic potential of tegoprubart, beginning with top-line data from our Phase 2a trial in ALS in the second quarter,” David-Alexandre C. Gros, MD, CEO of Eledon, said in a press release.
Tegoprubart is a lab-made antibody that targets a protein called CD40 ligand (CD40L) on the surface of certain immune cells. Binding of CD40L to its receptor CD40 has been shown to boost pro-inflammatory responses, including those leading to autoimmunity and neuroinflammation.
By inhibiting CD40L activation, tegoprubart can halt AlS’s damaging inflammatory responses and other inflammatory conditions. This inhibition also induces T-cells to take on a more immunosuppressive role, and to further dampen immune responses, according to Eledon.
In animal models of ALS, tegoprubart was found to delay disease onset and extend survival, which is consistent with the critical role of neuroinflammation in ALS progression.
A single ascending dose of tegoprubart was deemed safe and well-tolerated in healthy volunteers and ALS patients in a previous Phase 1 trial. This led Anelixis Therapeutics (now part of Eledon) to initiate a Phase 2a trial to test multiple ascending doses of the therapy.
The ongoing trial is investigating the safety and tolerability of four doses — 1, 2, 4, and 8 mg/kg — in 54 ALS patients diagnosed in the previous two years.
Participants will receive six infusions into the vein, given every other week for 11 weeks. They will be monitored for treatment safety and tolerability for another eight weeks. The trial is expected to last about five months.
Investigators also will determine if tegoprubart can slow disability progression on the ALS Functional Rating System-Revised (ALSFRS-R) scale and prevent lung function decline.
Its impact on the levels of certain markers of inflammation and markers of neurodegeneration also will be assessed.
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