-FASST Phase 2b Clinical Trial on Track to Complete Enrollment in 2nd Half of 2017
-Topline Results Anticipated in 2nd Half of 2018
Daix (France) April 10, 2017 – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today that it has achieved an important milestone in its development of IVA337 for the treatment of systemic sclerosis (SSc), by enrolling the 100th patient into the Phase IIb FASST trial. The trial, which began in December 2015, is now 75% enrolled. The Company is currently on track to complete enrollment in the second half of 2017, with topline results expected to be available 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," said Fre´de´ric Cren, CEO and co-founder of Inventiva. "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.
"Systemic sclerosis is a fatal orphan disease with no approved treatment. Current treatment is directed mainly toward managing complications and providing symptomatic relief," said Professor 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. 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"
"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," said Professor Yannick Allanore, Professor of Rheumatology at Ho^pital Cochin in Paris and co-Principal Investigator in the FASST trial. "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."
FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across eight European countries. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.
In November 2014, the European Medicines Agency (EMA) granted IVA 337 the orphan drug status for the treatment of systemic sclerosis. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and ten years of commercial exclusivity.
"Much in line with this Phase IIb study in which patient enrollment is progressing very well, we are pursuing the execution of our clinical development plan we announced during our initial public offering in February. We remain on schedule to report important clinical results from mid-2018 in our three main indications, which are NASH, MPS VI and systemic sclerosis," concluded Fre´de´ric Cren, Inventiva’s CEO and co-founder.
-Topline Results Anticipated in 2nd Half of 2018
Daix (France) April 10, 2017 – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today that it has achieved an important milestone in its development of IVA337 for the treatment of systemic sclerosis (SSc), by enrolling the 100th patient into the Phase IIb FASST trial. The trial, which began in December 2015, is now 75% enrolled. The Company is currently on track to complete enrollment in the second half of 2017, with topline results expected to be available 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," said Fre´de´ric Cren, CEO and co-founder of Inventiva. "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.
"Systemic sclerosis is a fatal orphan disease with no approved treatment. Current treatment is directed mainly toward managing complications and providing symptomatic relief," said Professor 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. 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"
"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," said Professor Yannick Allanore, Professor of Rheumatology at Ho^pital Cochin in Paris and co-Principal Investigator in the FASST trial. "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."
FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across eight European countries. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.
In November 2014, the European Medicines Agency (EMA) granted IVA 337 the orphan drug status for the treatment of systemic sclerosis. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and ten years of commercial exclusivity.
"Much in line with this Phase IIb study in which patient enrollment is progressing very well, we are pursuing the execution of our clinical development plan we announced during our initial public offering in February. We remain on schedule to report important clinical results from mid-2018 in our three main indications, which are NASH, MPS VI and systemic sclerosis," concluded Fre´de´ric Cren, Inventiva’s CEO and co-founder.
