Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AT-1501 · 4 trials · 3 indications
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Maximum observed plasma concentration (Cmax)
Time to reach maximum observed plasma concentration (Tmax)
Terminal elimination rate constant (Ke)
Terminal phase half-life (t1/2)
Clearance (CL)
Volume of distribution at steady state (Vdss)
| Arm | Type | Description |
|---|---|---|
| AT-1501 | EXPERIMENTAL | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | ACTIVE_COMPARATOR | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
| Investigative | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Comparator | ACTIVE_COMPARATOR | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
| AT-1501 Single Arm | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Name | Type | Description |
|---|---|---|
| AT-1501 | DRUG | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | DRUG | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
Inclusion Criteria: * Successfully completed qualifying Parent study, where entry into the OLE was offered; * Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent; * Agree not to participate in...
AT-1501, also known as tegoprubart, is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS) and for the prevention of rejection in kidney transplant patients. It is currently in Phase 2 clinical trials for these indications.
AT-1501 is a small molecule that targets CD40 ligand, a protein involved in immune system activation. By blocking this target, it aims to modulate immune responses, which is relevant for treating autoimmune conditions like ALS and for preventing organ transplant rejection.
AT-1501 is being developed by Eledon Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ELDN. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
AT-1501 is in Phase 2 clinical development. It has completed a Phase 2 trial in ALS and a Phase 2 trial in kidney transplant rejection, and an additional Phase 2 trial is currently enrolling by invitation for long-term safety and efficacy in kidney transplant recipients.
AT-1501 has been studied in several clinical trials. NCT04322149 was a completed Phase 2 trial in ALS. NCT05027906 is a recruiting Phase 1 trial for kidney transplant rejection prevention. NCT05983770 was a completed Phase 2 trial in kidney transplant rejection, and NCT06126380 is a Phase 2 trial enrolling by invitation for long-term safety and efficacy.
Yes, AT-1501 is also known as tegoprubart. Clinical trials such as NCT05983770 and NCT06126380 use the name tegoprubart to refer to the same investigational drug being developed by Eledon Pharmaceuticals.