A key milestone has been achieved in the development of Inventiva’s IVA337, an anti-fibrotic drug for treating systemic sclerosis (SSc), with the enrollment of the 100th patient in the Phase 2b FASST trial.
The FASST trial (NCT02503644) has now 75% of subjects enrolled, and the company expects to complete enrollment by the end of 2017. The trial first results are expected in the second half of 2018.
“We are pleased that the FASST study is proceeding on schedule, underscoring the interest we are seeing from physicians and patients in IVA337,” Freìdeìric Cren, CEO and co-founder of Inventiva, said in a press release.
“To deliver on the recruitment timelines is of major importance for Inventiva. With the opening of additional sites in new countries, we are confident that enrollment will be finalized by the end of this year, delivering the first results in the second half of 2018,” said Pierre Broqua, CSO and co-founder.
The FASST study was approved by the European Medicines Agency (EMA). Its main objective is to evaluate the effects of IVA337 on the progression of SSc. This will be determined by assessing the changes in the modified Rodnan skin score, a parameter of disease progression accepted by both the EMA and the U.S. Food and Drug Administration (FDA).
“Systemic sclerosis is a fatal orphan disease with no approved treatment. Current treatment is directed mainly toward managing complications and providing symptomatic relief,” said Chris Denton, professor of experimental rheumatology at University College London and co-principal investigator of the FASST trial.
“IVA337 has a unique mechanism of action and has demonstrated evidence of a therapeutic benefit in prior studies,” Denton said. “It has the potential to be a true disease modifying agent and potentially highly effective treatment in this disease. I look forward to completing this important study and reporting results in 2018.”
Yannick Allanore, professor of rheumatology at Hôpital Cochin in Paris and the other co-principal investigator in the FASST trial, said the anti-fibrotic activity of IVA337 has been demonstrated in preclinical studies, “including recent experiments demonstrating anti-fibrotic activities in relevant models of lung and kidney fibrosis.”
“These studies reinforce the rationale of developing IVA337 in the SSc population. The FASST clinical trial will generate further insight into the beneficial effects of IVA337 in humans, and I look forward to the results next year,” he added.
IVA337 has been awarded orphan drug designation by both the EMA and the FDA for the treatment of systemic sclerosis, which ensures expedited regulatory activity and reduced fees, along with 10 years of commercial exclusivity.