Delenex Therapeutics AG has announced new clinical data of its lead program DLX105. DLX105 is a PENTRA®Body targeting TNFα for the treatment of inflammatory skin and autoimmune disorders.
In a double-blind, parallel-group, placebo-controlled phase 2 study involving 24 healthy volunteers, the pharmacokinetics of three dose levels of i.v. DLX105 were studied. A high volume of distribution was observed indicating effective and fast tissue distribution making it a promising candidate to treat patients with flaring inflammatory diseases. A total of 6 patients with flaring Behçet’s disease were subsequently enrolled in an open-label study.
Each patient received a single dose of 10 mg/kg DLX105 i.v.. Rapid resolution of cutaneous and mucosal eruptions typical for flaring Behçet’s disease was observed. Within a week post injection of DLX105 signs and symptoms of the preceding flare had almost completely disappeared confirming the rapid and efficient therapeutic activity of a single injection of DLX105 in those inflamed lesions. The clinical response was evident up to 4 weeks post treatment.
“The fast and almost complete resolution of erythemata nodosa following a single infusion of DLX105 in one of our patients was particularly remarkable. The patient suffered from those difficult-to-treat skin nodules for already 5 years and all previous systemic therapies were ineffective,” said Theodoros Xenitidis, MD, University of Tübingen and investigator in this study. Also Ina Kötter, MD, investigator from Hamburg, confirmed substantial improvement of clinical symptoms of her treated patients.
“As the applied single dose of DLX105 showed clinical activity up to 4 weeks, we have good evidence to believe that high biological activity associated with excellent tissue penetration into the inflamed lesions makes a difference to these patients. In addition, treatment was well tolerated,” commented Thomas Jung, MD, Chief Medical Officer at Delenex. “The data add substantial evidence to our proof-of-concept demonstrating the value of small and highly potent PENTRA®Bodies for inflamed skin and autoimmune disorders,” adds Thomas Hecht, MD, Executive Chairman of Delenex.