Corbus Pharmaceuticals is sharing a host of data on anabasum (JBT-101) for the treatment of diffuse cutaneous scleroderma at the ongoing American College of Rheumatology (“ACR”) 2017 Annual Meeting in San Diego.
Researchers presented data from an earlier Phase 2 trial of the cannabinoid-derived drug, along with a study proving its ability to resolve skin inflammation, according to a press release.
Corbus, which earlier presented preliminary results from that study, has since expanded on the data. Robert F. Spiera of New York’s Hospital for Special Surgery, will show that anabasum caused no serious, severe or unexpected adverse effect in the study, which included 42 patients with diffuse cutaneous systemic sclerosis (dcSSc).
The medication appeared to be linked to dizziness and fatigue, though it did improve several measures of disease severity, including the modified Rodnan Skin Score (mRSS).
“Anabasum had acceptable safety and tolerability in this Phase 2 trial in dcSSc and demonstrated consistent evidence of clinical benefit,” researchers wrote.
Spiera presented data Nov. 5 from an open-label long-term extension study, which recruited most of the patients who completed the Phase 2 trial. Safety analyses showed adverse events were mostly mild or moderate and unrelated to treatment, also in the long run.
Importantly, the study showed that in the median 50 days between the studies, patients remained stable. Once they started anabasum treatment, they continued improving.
Viktor Martyanov fof the Geisel School of Medicine at Dartmouth University in Hanover, New Hampshire, presented data on gene activity analyses, performed on tissue samples from the Phase 2 trial.
Findings indicated that the treatment normalized activity in genes related to inflammation and fibrosis. But most patients who improved on anabasum treatment had abnormally high activity in inflammatory or fibrosis-promoting skin genes at the study’s beginning.
In contrast, those who improved on placebo had increased activity of normal-like genes at its start. This, researchers suggest, means they can use this information to identify patients most likely to improve spontaneously.
On another note, Ada Man of Canada’s University of Manitoba spoke on validating the Systemic Sclerosis Skin Symptoms Patient-Reported Outcome (SSPRO) — a tool for the measurement of health-related quality of life used in the Phase 2 trial.
The SSPRO measures outcomes related to skin involvement in scleroderma. The tool complements current measures of how patients with diffuse scleroderma perceive their situation.
Finally, a trial in healthy volunteers showed that anabasum triggered an anti-inflammatory response, leading to timely resolution of inflammation.
“Anabasum is a first-in-class therapy targeting four rare inflammatory-fibrotic diseases with clear unmet needs and significant morbidity and mortality, including systemic sclerosis,” Corbus CEO Yuval Cohen told Scleroderma News in a prepared statement. “It’s the first-ever non-immunosuppressive therapy in development for this rare inflammatory-fibrotic disease and has the potential to impact lives of the 90,000 individuals living with systemic sclerosis in the U.S. and EU, where no systemic sclerosis specific drugs have been approved.”
Besides systemic sclerosis, anabasum is also being developed as a therapy for cystic fibrosis, skin-predominant dermatomyositis and systemic lupus erythematosus.
“Anabasum has generated positive Phase 2 data in three of our indications thus far and we remain very encouraged as it continues to show promise as an effective therapy, demonstrating a clear signal of clinical benefit and a favorable safety profile in each of the completed and extension studies,” Cohen said. “We remain focused on the goal of bringing patients and physicians a safe and effective therapy that resolves inflammation to the market, first with our lead indication in systemic sclerosis, potentially as soon as 2021.”
Corbus expects to launch a Phase 3 trial on anabasum in diffuse cutaneous scleroderma patients by year’s end.