ResoTher Pharma today announced that the company has received approval to initiate human clinical development with RTP-026, the company’s lead peptide drug candidate.
The phase I trial will be conducted at a clinical site in Liege, Belgium where intravenous infusion of escalating doses of RTP-026 will be administered to healthy volunteers. The primary objective of the trial is to evaluate the safety, tolerability and pharmacokinetics of RTP-026 in humans with the aim to establish recommended doses for further studies in patients (i.e. Phase 2 studies). The effects on biomarkers and cardiac safety will also be assessed. The trial is expected to conclude in Q3 2022.
ResoTher Pharma’s CEO, Lone M Veng said “We are pleased to be embarking on clinical development with RTP-026. This represents an important milestone for the company, as we now move into human trials and thereby closer to studies in patients. In recent years, our understanding of the way inflammation contributes to cardiovascular disease has greatly expanded and we are excited that we will be contributing to the growing knowledge in this field as we move forward into clinical development”.
Thomas Jonassen, MD, the company’s founder and Chief Medical Officer added: “We have high hopes for RTP-026 as a new and effective treatment for patients with myocardial infarction. RTP-026 represents a new and innovative way to modulate the inflammatory response that is generated in the heart during the recovery phase of a myocardial infarction. Especially in the subset of patients, showing high inflammatory activity, there is a need for novel treatments to reduce the risk for reinfarction and other major cardiovascular events.