Pharma Fridays – November 3, 2023

An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information.*

New Clinical Data Point to Use of GlycoMark as Biomarker of SGLT-2 Diabetes Drug Effectiveness and Compliance

Precision Diabetes, Inc. announces new studies that show that the GlycoMark blood test, which measures 1,5-anhydroglucitol, may be useful for evaluating short-term effectiveness and assessing patient compliance of SGLT-2 inhibitor diabetes drugs. SGLT-2 inhibitors are a relatively new and popular class of drugs for patients with type 2 diabetes. Medicines in the SGLT-2 inhibitor class include canagliflozin, dapagliflozin, emagliflozin, and ertugliflozin.

In a recent study presented at the American Diabetes Association (ADA) Scientific Sessions, “GlycoMark 1,5-Anhydroglucitol Values in Patients Taking SGLT-2 Inhibitors,” clinical investigators from Aveon Health (Scottsdale, AZ) conducted a review of their patients treated with an SGLT-2 inhibitor and their corresponding GlycoMark test results. Of 240 patients being treated with an SGLT-2 inhibitor, 92% had a GlycoMark test result that was on the extremely low end of abnormal (< 2 µg/mL), and the average GlycoMark result was 1.2 µg/mL.

“We have long suspected that SGLT-2 inhibitor use is associated with extremely low GlycoMark results, even lower than typically seen for patients with persistent hyperglycemia,” said Sam Fereidouni, MD, MHSA, medical director at Aveon Health, and lead investigator on the study. We hypothesized that extremely low GlycoMark results were not an indicator of very poor glycemic control but were rather indicating compliance with the medication as prescribed and achieving the desired effect, which is the elimination of glucose in urine.”

Additional studies also support the use of GlycoMark as a biomarker of SGLT-2 inhibitor drug effectiveness. In a recent study published in Clinica Chimica Acta, “Model Analysis of effect of canagliflozin (Invokana), a sodium-glucose cotransporter 2 inhibitor, to alter plasma 1,5-anhydroglucitol,” the study authors conclude that “according to model calculations, a substantial and likely rapid effect on canagliflozin therapy on 1,5-anhydroglucitol means that 1,5-anhydroglucitol measurement (GlycoMark) might provide an early marker of canagliflozin therapy activity.”

In another study, “1,5-anhydroglucitol is a good predictor for the treatment effect of the Sodium-Glucose cotransporter 2 (SGLT-2) inhibitor in Japanese patients with type 2 diabetes mellitus (Journal of Clinical and Translational Endocrinology),” 1,5-anhydroglucitol was the most reliable indicator of SGLT-2 drug effectiveness – with the study authors stating that “1,5-anhydroglucitol has detective ability more useful for patients than HbA1c value or eGFR value.”

Taken together, this new clinical data shows that the GlycoMark test helps confirm patient compliance and the appropriate response to SGLT-2 inhibitors – which may be useful in both clinical practice and clinical drug trials.

New Human Biomarker Findings Support Mechanism of Action of Kerendia® (finerenone) in Patients with Chronic Kidney Disease Associated with Type 2 Diabetes

At the American Society of Nephrology’s (ASN) Kidney Week 2023, Bayer today announced pharmacodynamic data on Kerendia® (finerenone), the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate dual cardiorenal risk reduction in adult patients with chronic kidney disease (CKD) and type 2 diabetes.

Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes. The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia. For more information, see “Important Safety Information” below.

The data from FIGARO-BM, an exploratory human biomarker study, provide findings which support the mechanism of action of Kerendia in blocking MR overactivation, thought to contribute to inflammation and fibrosis. Left untreated, inflammation and fibrosis can lead to damage in the kidneys and heart. 

“The biomarker findings from FIGARO-BM are an important moment for Bayer,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and head of Research and Development. “In addition to existing preclinical data, we now have data from human biomarkers that support finerenone’s mechanism of action in blocking MR overactivation which can lead to inflammation and fibrosis.”

The FIGARO-BM study aims to elucidate the mode-of-action (MOA) of finerenone. More than 2,900 plasma biomarkers derived from biosamples from 945 patients who were treated with either placebo or finerenone for at least 36 months in the Phase III study FIGARO-DKD were analyzed. 

Future studies are needed to validate these findings.

*Inclusion in Pharma Fridays does not suggest an endorsement by Endocrine News or the Endocrine Society.

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