- First programme from the Topas platform to enter clinical testing
- TPM203 is one of several proprietary programmes being developed by Topas
- Pemphigus vulgaris is an orphan indication that currently has no cure
Hamburg, Germany, 18 December 2019
Evotec spin-off Topas Therapeutics GmbH (“Topas”), a Hamburg, Germany-based private platform company leveraging the natural tolerance induction capabilities of the liver, today announced that the first patient has been enrolled in a first-in-human Phase 1 trial evaluating TPM203 in patients with pemphigus vulgaris ("PV"), an orphan autoimmune disease. TPM203 is Topas' most advanced programme and the first one from the Company's proprietary Topas Particle Conjugates ("TPC") platform technology to enter the clinic.
"The initiation of the first clinical study with our lead product candidate is an exciting and at the same time value-generating step forward for Topas," said Timm Jessen, PhD, Chief Executive Officer. "Pemphigus vulgaris is a well characterised disease with extensive knowledge on the most related autoimmune antigen and biomarkers available. It provides a very good setting to demonstrate the successful translation of our Topas Particle Conjugates platform into the clinic. While treatments do exist for this painful condition, there currently is no cure, and we look forward to advancing TPM203 with the goal of helping patients with this debilitating disease."
The Phase 1 trial is an open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of TPM203, as well as to explore early signs of effectiveness for TPM203 to induce antigen-specific immune tolerance in this patient population. The study has a single-ascending dose phase, followed by a multiple dose phase. The trial is planned to treat 24 patients and will be conducted at approximately seven sites in Germany; the coordinating investigator is Prof. Michael Hertl from the Dept. of Dermatology and Allergology at University Medical Center Marburg.
For to the full press release by Topas Therapeutics, please follow this link.