KIND Announces Positive Results for AND017 in Treating Anemia from Chronic Kidney Disease

Clinical Trials at American Society of Nephrology (ASN) – Kidney Week 2024

SAN FRANCISCO, Oct. 28, 2024 -- Kind Pharmaceutical, comprising Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC, has unveiled promising outcomes from four clinical studies of their leading program, AND017, intended for treating anemia in both non-dialysis and dialysis-dependent chronic kidney disease (CKD) patients. These were showcased during the annual meeting of the American Society of Nephrology (ASN) Kidney Week in San Diego.

The four trials included a first-in-human trial in Austria, examining healthy subjects, a trial in China appraising food effects on pharmacokinetics (PK), and two Phase 2 trials evaluating anemia in CKD patients in both the US and China.

In Austria, the AU-001 trial was a double-blinded, placebo-controlled trial in healthy volunteers. AND017 revealed favorable linear oral PK, with an elimination half-life (T1/2) ranging from 11.9 to 19.7 hours in the single ascending dose (SAD) part, and from 10.1 to 19.4 hours in the multiple ascending dose (MAD) part. Preliminary pharmacodynamic (PD) markers, such as erythropoietin (EPO) and hemoglobin (Hb), were also observed. AND017 was well tolerated at all doses administered.

The CN-101 trial in China explored the effect of food on the PK of AND017 in non-elderly healthy subjects. This randomized, open-label, two-period crossover study showed that the drug's formulation could be taken with or without food, with a Fed/Fasted ratio of 79.61% for Cmax and 99.93% for AUC0-inf.

The MN-201 trial, a Phase 2 study, involved 113 non-dialysis-dependent CKD patients from the US and China. Participants received AND017 at different doses or a placebo. The results showed a significant increase in hemoglobin levels in all AND017 groups compared to the placebo, with a linear correlation between the dose and Hb rise. The safety profile was comparable to the placebo, with no serious adverse events related to the treatment.

The MN-202 trial, another Phase 2 study, involved patients with dialysis-dependent end-stage kidney disease (ESKD) in both the US and China. Participants were randomized to receive either AND017 at two different dosing regimens or an active comparator, erythropoietin-stimulating agents (ESA). AND017 proved non-inferior to ESA in maintaining Hb levels within the target range over 20 weeks, with a favorable safety profile. The only treatment-related adverse event was hyperkalemia in one patient from the AND017 group.

Dr. Pablo E. Pergola, an expert in nephrology, stated that AND017 showed promising safety and efficacy in increasing and maintaining Hb levels in both non-dialysis and dialysis-dependent CKD patients. Dr. Qi Zhu, Chief Medical Officer of Kind Pharmaceutical, expressed excitement over the results, highlighting the potential for longer interval dosing to mitigate issues seen in previous trials.

Summary results from these trials are available on Kind Pharmaceutical's website. The positive outcomes have led to the FDA granting Orphan Drug Designation to AND017 for treating Sickle Cell Disease (SCD).

Chronic kidney disease (CKD) affects a significant portion of the population, with anemia being a common complication. In the US, about 14% of adults have CKD, with similar prevalence in China. Anemia in CKD patients increases the risk of cardiovascular events and mortality.

AND017, a first-in-class hemoglobin elevating agent, targets multiple stages of the red blood cell life cycle. It is being developed for treating various types of anemia, including those associated with CKD, cancer, myelodysplastic syndromes, sickle cell disease, and β-thalassemia.

Kind Pharmaceutical is a clinical-stage biopharmaceutical company dedicated to creating innovative treatments for hematological diseases and cancers. Their mission emphasizes a commitment to advancing science to meet unmet medical needs.