kiny
Well-known member
Italian drug company GIULIANI sponsored trials of their drug in Italy on crohn's disease patients, wtih highly successful results in the first two trials they claimed. In a large phase III trial outside of Italy, it was completely ineffective and they were forced to stop development.
2015 https://www.nejm.org/doi/10.1056/NEJMoa1407250?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov
"In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease.
We found that study participants with Crohn's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo. "
2018 https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(17)36068-7
"Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn’s Disease
Endoscopic improvement was observed in 37% of participants with evaluable endoscopy results at week 12. At week 12, 32% (4 weeks), 35% (8 weeks), and 48% (12 weeks) of patients receiving GED-0301 were in remission. "
2019 https://insights.ovid.com/pubmed?pmid=31850931
"Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.
At study termination, proportions of patients achieving clinical remission at week 52 were similar among individual GED-0301 groups and placebo. More placebo vs GED-0301 patients achieved endoscopic response. Two deaths occurred (GED-0301 total group) due to small intestinal obstruction and pneumonia; neither was suspected by the investigator to be treatment-related.
GED-0301 did not demonstrate efficacy vs placebo in active CD. "
2020
"GED-0301 Unsuccessful Treating Active Crohn's Disease. GED-0301 (Mongersen) will not be prescribed to treat active Crohn's disease after negative results from a phase 3 clinical trial. "
2015 https://www.nejm.org/doi/10.1056/NEJMoa1407250?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov
"In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease.
We found that study participants with Crohn's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo. "
2018 https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(17)36068-7
"Effects of Mongersen (GED-0301) on Endoscopic and Clinical Outcomes in Patients With Active Crohn’s Disease
Endoscopic improvement was observed in 37% of participants with evaluable endoscopy results at week 12. At week 12, 32% (4 weeks), 35% (8 weeks), and 48% (12 weeks) of patients receiving GED-0301 were in remission. "
2019 https://insights.ovid.com/pubmed?pmid=31850931
"Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.
At study termination, proportions of patients achieving clinical remission at week 52 were similar among individual GED-0301 groups and placebo. More placebo vs GED-0301 patients achieved endoscopic response. Two deaths occurred (GED-0301 total group) due to small intestinal obstruction and pneumonia; neither was suspected by the investigator to be treatment-related.
GED-0301 did not demonstrate efficacy vs placebo in active CD. "
2020
"GED-0301 Unsuccessful Treating Active Crohn's Disease. GED-0301 (Mongersen) will not be prescribed to treat active Crohn's disease after negative results from a phase 3 clinical trial. "
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