Phase 3 Trial of CXCL-8 Inhibitor Ladarixin Launched for New-Onset Type 1 Diabetes: Aims to Preserve Pancreatic β-Cell Function and Slow Disease Progression

January 17, 2021 /Bio ValleyBIOON/ -- Italy's leading biopharmaceutical company, Dompe, recently announced the evaluation of the novel oral small-molecule drug ladarixin for the treatment of new-onset type 1DiabetesPhase 3 Study on the Efficacy and Safety in Adolescent and Adult Patients with Type 1 Diabetes (T1D)Clinical TrialThe first patient has been enrolled.

This is a randomized, multicenter, double-blind, placebo-controlled Phase 3 trial enrolling adolescent and adult patients with newly diagnosed type 1 diabetes (T1D) who have lower residual β-cell function. The primary objective is to evaluate the efficacy of maintaining β-cell function by inhibiting the biological activity of CXCL-8 (IL-8). Currently, the trial is being conducted in the United States.Clinical TrialsPatient recruitment has been initiated at the sites, with the study scheduled to commence in the first half of 2021. Recruitment at European trial sites is expected to continue through 2022.

Ladarixin Phase 3Clinical TrialsThe initiation followed the results of the Phase 2 trial (NCT02814838), which were presented at the 2020 AmericanDiabetesAssociation (ADA) Online ScienceConferencepublished online and appeared in the international medical journal Diabetes in June 2020. In the Phase 2 study, no clinically relevant safety findings were detected between the two study groups. Furthermore, in the Phase 2 study,A Novel Approach to Inhibiting CXCL-8 (IL-8) Demonstrates Promising Efficacy in Preserving Pancreatic β-Cells and Delaying Disease Progression in Patients with Newly Diagnosed Type 1 DiabetesIn the study, ladarixin was well tolerated.

T1D is a chronicAutoimmunitydiabetes, over time, leads to the loss of immune-mediated functional pancreatic β-cell mass, resulting in symptomaticDiabetesand lifelong insulin dependence. Currently available treatments focus on glycemic control and do not address the high unmet medical need to delay disease progression by preserving β-cell function.。

CXCL-8, also known as IL-8, is a pro-inflammatory chemokine involved in innate immune responses and serves as a key mediator in various immune and metabolic diseases, including type 1 diabetes (T1D). Modulating or inhibiting CXCL-8 activity by blocking its cellular receptors, CXCR1/2, may be considered a target for developing innovative therapies aimed at slowing the progression of T1D.

Ladarixin is an investigational oral small molecule that functions as a non-competitive dual allosteric inhibitor of the CXCL8 (IL-8) receptors CXCR1 and CXCR2. By blocking CXCR1/2 receptors, ladarixin can prevent inflammation and immune system-mediated destruction of β cells in the pancreatic islets, which is a hallmark of type 1 diabetes (T1D). CXCR1/2 inhibition has been shown to prevent and reverse T1D in mice. Currently, ladarixin has not been approved for use in any country. (Bioon.com)

Original Source: Dompé Announces First Patient Enrolled in Phase 3 Trial of Ladarixin, an Oral Investigational CXCR1/2 Inhibitor, in New-Onset Type 1 Diabetes (T1D)