DRUG CANDIDATES
RK-01 (TriGlytza®)
RK-01 (TriGlytza®) has a novel, first-in-class mechanism of action that broadly prevents progressive deterioration of pancreatic beta cell function and reduces the risk of development of insulin resistance in patients with Type 2 Diabetes Mellitus (T2DM).
TriGlytza® can be used as a stand-alone therapy or as an adjunct to improve efficacy and optimise the effects of Metformin – the current first-line gold standard treatment for T2DM.
TriGlytza® has received FDA approval to conduct a Phase II clinical trial in T2DM patients
RESILIENCE – REStoration of InfLammation-trIggered bEta-cell failure and decrease in insulin resistaNCE.
TriGlytza® Key Features:
• Beta-cell centric dual-combination therapy
• Adjunctive therapy to current blockbuster drugs
• Addresses pancreatic beta cell deterioration
• Improves existing therapy effectiveness
• Established safety profile
Target Patients:
• T2DM treatment-naive (preserve beta-cells)
• T2DM treatment-ineffective (restore function)
• T2DM treatment failures (enhance effectiveness of T2DM therapies)
• T2DM patients with comorbidities and/or diabetes complications
• N = 122 adult patients
• Multi-site trial in Australia and the US
• Patients with T2DM currently being treated with Metformin OR treatment naïve
• 29-week treatment period
• Primary Endpoint: TriGlytza® is superior to Metformin monotherapy in improving glycaemic, inflammatory, and atherogenic biomarkers of T2DM
RK-01 RESILIENCE STUDY
FDA IND#136121 clinicaltrials.gov ID:NCT03686657
Pipeline
Myopharm is developing a novel precision medicine approach for multiple diabetes, diabetes-related, and systemic inflammatory indications.
Myopharm has a pipeline of indications designed to address extensive metabolic indications within an approved IND.
We were incredibly honoured that the American Diabetes Association(ADA) featured Myopharm Limited in the Thought Leadership Film Series, a part of ADA’s 84th Scientific Sessions program in June 2024.
In the invitation letter, it was written:
We are interested in profiling Myopharm’s pioneering work to revolutionize the treatment landscape for Type 2 diabetes, including your work on TriGlytza®. Despite the extensive array of treatments currently available, none specifically address the root cause of the disease with a focus on preserving and enhancing the function of pancreatic beta cells, a critical unmet need in the diabetic community. Given that your work introduces a novel ‘Beta-cell centric’ therapeutic strategy, aiming to maintain or restore beta-cell function while mitigating insulin resistance, we believe your work has the potential to make an incredibly valuable addition.