Novel Drug & Emergent Therapeutics | Pharmaceuticals | Rare Diseases
Positive Phase II results show AND017’s effectiveness in treating CKD-related anaemia, as the drug also receives FDA Orphan Drug designation for Sickle Cell Disease.
Time to read: 02:44
Originally published: 29 October 2024
Source: PRNewswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN002
Category: Rare Diseases
Crossreference: Blood Disorders, Nephrology
Category tags: pacemaker leads, Boston Scientific,
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| FDA Orphan Drug Status |
SAN FRANCISCO, Oct. 28, 2024 /PRNewswire/ --
Kind Pharmaceuticals, a clinical-stage biopharma focused on haematological and cancer treatments, presented positive trial results for AND017 in treating anaemia in both non-dialysis chronic kidney disease (NDD-CKD) and dialysis-dependent chronic kidney disease (DD-CKD) at ASN Kidney Week in San Diego.
AND017 is a first-in-class haemoglobin (Hb) elevating agent that targets multiple stages of the red blood cell lifecycle. Beyond treating anaemia associated with both dialysis-dependent (DD-CKD) and non-dialysis-dependent chronic kidney disease (NDD-CKD), it is also in development for anaemia related to cancer, myelodysplastic syndromes, sickle cell disease (SCD), and β-thalassemia.
The FDA granted AND017 Orphan Drug Designation (ODD) on October 25, 2024, for the treatment of Sickle Cell Disease (SCD).
These latest AND017 trials included a first-in-human study in healthy subjects in Australia, an evaluation of pharmacokinetics in China, and two phase II trials assessing anaemia in NDD-CKD and DD-CKD across both the U.S. and China.Below is a summary of each.
A Dose-escalation Study of AND017 in Healthy Subjects
The AU-001 first-in-human, double-blinded, placebo-controlled trial, conducted in Australia, showed that AND017 had favourable pharmacokinetics: was processed in the body at a steady rate, with an elimination time of 10 to 20 hours, depending on the dose.
The study included both single doses (1 mg to 50 mg) and multiple doses over 10 days (4 mg to 30 mg daily).
Early signs showed that AND017 might have effects on key markers like erythropoietin (EPO) and haemoglobin (Hb), which relate to blood health. Importantly, AND017 was found to be safe and well tolerated across all doses tested in the trial.
Registration: NCT04751539
A Food-Effect Study of AND017 in Healthy Participants
The CN-101 randomized, open-label, two-sequence, two-period, crossover, single-dose (10 mg) trial conducted in China tested how food affects the body’s absorption of the drug AND017.
It showed that Food slightly lowered the peak concentration (Cmax) of AND017 in the blood to about 80% of the fasting level, but the overall exposure (AUC) remained nearly the same, around 100%. These findings show that AND017 can be safely taken with or without food.
Registration: NCT04712500
A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
The MN-201 phase II study evaluated AND017 in 113 patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) across the U.S. and China.
AND017 significantly raised haemoglobin (Hb) levels compared to the placebo in a dose-dependent manner. Hb levels remained within the target range (10-11 g/dL) during titration, and AND017 showed a safety profile comparable to placebo with no treatment-related serious adverse events.
Registration: NCT05035641
A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis
The MN-202 phase II study tested AND017 for anaemia in dialysis-dependent end-stage kidney disease (ESKD) patients in the U.S. and China.
Both AND017 dosing regimens showed non-inferiority to ESA in maintaining Hb) levels within the target range. Treatment-emergent adverse events (TEAEs) were comparable between groups, with hyperkalemia as the only treatment-related TEAE in one patient.
No treatment-related serious adverse events occurred, demonstrating AND017’s safety and efficacy.
Registration: NCT05265325
Company Comment
AND017 demonstrated adequate safety and effectively increased and maintained haemoglobin levels in the 10.0-11.0 g/dL range in two Phase II studies involving both NDD and DD CKD patient populations. Efficacy and safety will be further assessed in Phase III trials," said Pablo E. Pergola, MD, PhD, an expert in nephrology and the director of the Clinical Advancement Center, PLLC, a wholly-owned subsidiary of Renal Associates.
Access Original Press Release
28 October 2024 | PR Newswire | KIND Presents Positive Results of AND017 to Treat Anemia Associated with Chronic Kidney Disease in Two Phase II and Two Phase I
25 October 2024 | PR Wire | KIND Announces FDA Granted Orphan Drug Designation (ODD) for AND017 in the Treatment of Sickle Cell Disease (SCD)
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