An open-label extension of a Phase II study has shown that the experimental drug lenabasum is fairly safe and tolerable in patients who have diffuse cutaneous systemic sclerosis. The full article can be read here, at EurekAlert.

Diffuse cutaneous systemic sclerosis (dcSSc) is a type of systemic sclerosis, which is itself a form of scleroderma. Scleroderma is a rare condition that causes hardening and thickening of the skin and in some cases blood vessels and internal organs. It is caused by the body’s immune system attacking connective tissue that causes it to scar and thicken. Systemic sclerosis is a severe form of scleroderma that often affects blood vessels and organs as well as the skin. The subtype dcSSc is estimated to affect approximately one in 25,000 adults, and around four out of every five patients are female. Since this form of the disease often affects organs, the risks of serious and life-threatening complications are high for people with dcSSc.

The experimental drug lenabasum is being developed as another treatment option for people with dcSSc. A Phase II study investigating the drug was continued into an open-label extension (OLE). OLE studies allow patients to continue taking the drug for a longer period of time, and patients are given information about the medication they are taking (as compared to a blind study in which participants don’t know whether they are taking the medication or a placebo). Data from the thirty-six patients who took part in both the original Phase II trial and the OLE have now been announced.

The results indicate that lenabasum can benefit patients with dcSSc, and that the drug is acceptably safe. The 25 patients who continued OLE for a year showed, on average, an improvement of 56% on their ARC CRISS score (a test used to assess systemic sclerosis). These patients also showed improvements based on multiple other assessments. Information on the safety of lenabasum was also collected; out of the 36 patients in the OLE, seven suffered adverse events, none of which were severe. Three of the participants discontinued the trial, two due to adverse events. Dr Spiera, principle investigator, said,

“our results are very encouraging.”

Lenabasum in an experimental drug that works as a selective cannabinoid receptor type 2 agonist. This means that it is believed to influence a specific receptor to reduce inflammation and fibrosis, based on animal models.

What are your thoughts on this study? Share your stories, thoughts, and hopes with the Patient Worthy community!