Topas, therapeutics company, initiates Phase IIa Trial for Celiac Disease Treatment
Trial to assess symptom severity and immune tolerance after exposure to gluten.
Topas Therapeutics has commenced a Phase IIa clinical trial for TPM502, a potential treatment for individuals with celiac disease, an autoimmune condition.
The study, involving 42 adults diagnosed with celiac disease, will be placebo-controlled, double-blind, and randomized. It aims to evaluate the safety, tolerability, and pharmacodynamic effects of two TPM502 administrations in dose-escalating cohorts.
The trial will specifically assess symptom severity and immune tolerance following exposure to gluten.
Cristina de Min, Chief Medical Officer at Topas Therapeutics, stated, “The Phase IIa study aims to determine TPM502’s ability to promote immune toleration in celiac disease patients and confirm the safety profile of TPCs. It also underscores the potential of the Topas platform in developing innovative therapeutics for T-cell-mediated diseases. The progress of TPM502 marks a significant step forward in advancing our immune tolerance-based clinical pipeline, emphasizing our commitment to offering new treatments for patients with limited pharmaceutical options.”
TPM502 employs Topas Therapeutics’ nanotechnology, Topas Particle Conjugates, featuring a proprietary biocompatible polymer and conjugated disease-relevant antigens. It consists of nanoparticles carrying gluten-specific antigenic peptides, including major gluten epitopes for HLA-DQ2.5 found in most celiac disease patients.
The decision to launch the Phase IIa study is based on positive clinical data from the Phase I study of TPM203 in pemphigus vulgaris patients.
To strengthen its executive management team for mid-stage clinical development, the company has welcomed Mireia Gómez-Angelats as Chief Business Officer and Christian Schröter as Chief Operating Officer, bringing international pharmaceutical expertise onboard.
Published 25 May 2023 — based on information reported by ClinicalTrialsArena