Phase 3 Trial to Begin for Terguride in Diffuse Cutaneous Scleroderma

The German pharmaceutical company Medac, in August, will begin Phase 3 of a clinical trial to access the therapeutic potential of terguride, a disease-modifying drug for the treatment of diffuse cutaneous systemic sclerosis.

Terguride is a serotonin receptor blocker, acting at two particular serotonin receptors called 5-HT2A and 5-HT2B. Medac is convinced that stopping the nerve signaling in serotonin neurons will block the progression of fibrotic tissue development and blood vessel remodeling in organs affected by diffuse cutaneous systemic sclerosis.

The antifibrotic effects of terguride were recently discovered and since proven in a pilot study of diffuse cutaneous systemic sclerosis patients.

The drug also affects dopamine and α2-adrenergic receptors. Previous studies have shown that the compound is well tolerated. It is already approved in Japan and the Czech Republic for use in conditions linked to excessive production of the hormone prolactin.

The trial, “TERGuride plus symptomatic therapy In subjects with diffuse cutaneous Systemic Sclerosis,” (TERGISS), will test the safety and efficacy of terguride compared to placebo. Fifty study centers across 10 countries will participate.

Patients will receive oral terguride or placebo for 52 weeks in a double-blind, randomized fashion, and fibrotic tissue damage of the skin and other organs will be evaluated using the modified Rodnan Skin Score.

Drugs currently in use for systemic sclerosis focus on managing symptoms present in affected organs, without impacting the chronic progression of the disease.

Because  long-term clinical data for systemic sclerosis is scarce, a follow-up open-label trial will then be staged for another 52 weeks to better assess long-term effects of terguride on fibrotic symptoms.

In a press release provided to Scleroderma News, TERGISS principal investigator, Dr. Oliver Distler of the University Hospital Zurich, said no licensed medicine shown to have a genuine effect on the disease progression of diffuse cutaneous systemic sclerosis – yet.

“We hope that the TERGISS trial will demonstrate that terguride possesses this disease-modulating efficacy. The available data appear to indicate that terguride could fulfill an unmet medical need,” Distler said.