Medicalgorithmics has been selected by CRO company Simbec-Orion as a provider of remote diagnostic solutions for a clinical trial commissioned by biotechnology company Molecure. The clinical trial, which will involve approximately 90 patients at research centers in Europe and the USA, will utilize the PocketECG IV device and the cloud-based PC Client solution.
“We are delighted that a renowned international CRO company has recognized the value of the diagnostic quality and flexibility of our cardiac safety monitoring solutions. This further demonstrates that our technology is not only useful in the everyday diagnosis of patients, but also in clinical trials involving potentially new drugs,” says Magdalena Ślusarczyk, Clinical Service and Product Implementation Director at Medicalgorithmics and adds, “It is worth noting that, for the first time in clinical trials, patients will be examined with the use of the latest version of our PocketECG IV device, which will be used for cardiac monitoring and recording the response to the inhibitor. Participation in clinical trials aligns with our new development strategy and paves the way for our involvement in future clinical trials conducted by Polish and foreign biotechnology entities,” concludes Magdalena Ślusarczyk.
Biotechnology company Molecure is preparing to initiate a Phase II proof of concept clinical trial to determine the clinical efficacy and safety of the chitinase inhibitor OATD-01 in patients with active pulmonary sarcoidosis. The OATD-01 molecule, which completed Phase I clinical trials in 2020, is a dual chitinase inhibitor. Chitinases play a crucial role in the inflammatory and fibrotic processes observed in sarcoidosis, among others. The OATD-01 compound is the world’s first potential drug that utilizes chitinase blocking mechanism.
The Phase II clinical trial aims to assess the clinical efficacy, pharmacokinetics, pharmacodynamics and safety of the chitinase inhibitor OATD-01 in patients with active pulmonary sarcoidosis. It will be a Phase II clinical trial with a fixed dose of the compound administered. The trial will involve approximately 90 patients at research centers in Europe and the United States. Molecure expects that the trial will commence and the first patient will be enrolled in Q4 2023. Patients participating in the study will be monitored by Medicalgorithmics’ technology for approximately 6 weeks to detect any potential cardiac arrhythmias.
Medicalgorithmics has once again been selected to participate in international clinical trials this year. In April, a Swedish biopharmaceutical company AnaCardio, chose Medicalgorithmics as a cardiac safety monitoring equipment provider (PocketECG III) in the GOAL-HF1 clinical trial. This is a double randomized and double-blind Ib/IIa dose escalation and cohort expansion clinical trial in patients with heart failure and reduced left ventricular ejection fraction (HFrEF).