Topas Therapeutics Initiates Phase 2a Clinical Trial for TPM502 in Celiac Disease; Appoints Chief Business Officer and Chief Operating Officer

Topas Therapeutics, a clinical-stage biotech company developing novel antigen-specific immune tolerance therapies to treat autoimmune disorders, announced today the launch of a Phase 2a clinical study (NCT05660109) evaluating the safety, tolerability and pharmacodynamics of TPM502 in patients with celiac disease.

Engineered leveraging the company’s Topas Particle Conjugates (TPCs) nanotechnology, TPM502 is a mixture of nanoparticles carrying gluten-specific antigenic peptides comprising the major gluten epitopes for HLA-DQ2.5 present in the majority of celiac disease patients. The company has received approval to initiate TPM502’s clinical development in a Phase 2a study based on TPM502 preclinical data and clinical results from the Phase 1 study assessing Topas’ TPC TPM203 in patients with pemphigus vulgaris. Celiac disease is an autoimmune disorder affecting multiple millions of patients worldwide who suffer from symptoms ranging from mild digestive discomfort to severe, long-lasting complications.

“The Phase 2a study will determine the capacity of TPM502 to promote immune tolerization in celiac disease patients and will confirm the safety profile of TPCs. It will also further establish the potential of the Topas platform to generate novel therapeutics for the treatment of T-cell-mediated diseases,” commented Cristina de Min, MD, Chief Medical Officer of Topas Therapeutics. “The development of TPM502 is a significant step forward in the advancement of our immune tolerance-based clinical pipeline and illustrates our mission to bring novel disease-modifying treatments to patients with limited pharmacological options.”

The multi-center, double-blind, randomized, placebo-controlled Phase 2a trial will include 42 adult patients diagnosed with celiac disease and will evaluate the safety, tolerability and pharmacodynamic effects of 2 administrations of TPM502 in dose-escalating cohorts. Immune tolerance and symptom severity will be assessed following exposure to gluten. For more information on the Ph2a, please visit clinicaltrials.gov.

The company also announced two appointments to its executive management team. Mireia Gómez-Angelats, PhD, has joined as Chief Business Officer and Christian Schröter, PhD, as Chief Operating Officer, adding significant international pharmaceutical experience to Topas’ leadership as the company moves to mid-stage clinical development. Topas most recently announced the addition of Cristina de Min, MD, who joined the company as Chief Medical Officer.

Erich F. Greiner, Executive Chairman at Topas Therapeutics commented: “Topas is moving at a fast pace with the initiation of its second clinical study. We look forward to adding Christian and Mireia´s expertise to the executive team. They each bring two decades of experience in the pharmaceutical industry, which will be invaluable as Topas advances its platform into clinical development.”

Prior to joining Topas Therapeutics, Dr. Christian Schröter worked at Merck Group for more than 20 years, in multiple countries and at increasing levels of responsibility. He was notably Head of Strategy, Global Healthcare Operations, and Senior Director, Pharma Business Integration. He obtained his PhD in immunology at the University of Tübingen.

Dr. Gómez-Angelats brings a track record of pharmaceutical experience from the US and Europe in roles with increasing responsibilities in business development and R&D at Novartis, Bristol Myers Squibb, Johnson & Johnson and Almirall. Mireia holds a PhD in biochemistry and molecular biology from the University of Barcelona.