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 entitled
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 inflammation indications.
Myopharm has a pipeline of indications designed to address an extensive metabolic patent portfolio.
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.