Biogen Phase III choroideremia study did not meet primary endpoint
pharmafile | June 15, 2021 | News story | Manufacturing and Production | Biogen, choroideremia, phase III
Biogen has announced that its investigational gene therapy study for the potential treatment of choroideremia did not meet its primary endpoint.
The STAR study did not meet its primary endpoint of proportion of participants with a ≥15 letter improvement from baseline in best corrected visual acuity at Month 12, in the interventional group in comparison to the non-interventional control group, as measured by the early treatment of diabetic retinopathy study chart.
Additionally, the study did not demonstrate efficacy on key secondary endpoints. Safety results from the Phase III STAR study were consistent with previous studies.
Katherine Dawson, Head of the Therapeutics Development Unit at Biogen, said: “We extend our deepest gratitude to all those who contributed to the STAR study, including the participants, investigators, site staff, and the broader choroideremia community.
“While we are disappointed by the results of the STAR study, we are hopeful that the clinical insights gleaned from this study may help to shape therapeutic innovation for inherited retinal diseases including choroideremia, so that in the future there may be treatment options for the community affected by these debilitating disorders.”
Choroideremia is a rare, inherited retinal disease resulting in progressive vision loss, ultimately leading to blindness
At first, patients with choroideremia experience poor night vision and over time, slow, progressive visual loss that ultimately leads to blindness.
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