Biogen Announces Phase 2 PASSPORT Study Results: Further Development of Gosuranemab in PSP Will Not be Pursued

Biogen Announces Phase 2 PASSPORT Study Results:  Further Development of Gosuranemab in PSP Will Not be Pursued

Biogen today announced that they will discontinue further study of Gosuranemab as a potential therapy for PSP.  We know that this news is disappointing for our community, especially for the many of you who participated in the PASSPORT study.

The PSP Society of Canada, together with PSP Patient Groups from around the world, will continue to liaise with Biogen over the coming months to provide more information for patients and families as study results are analyzed and released.  We expect that a lay-person summary of the study results will be provided and we will share this with you as soon as it is available.

While this therapy did not prove to be an effective treatment for PSP, the value of a clinical trial in collecting data and building the overall body of scientific understanding of PSP is immeasurable.  We are encouraged by the continued research interest in tauopathies and hopeful that the knowledge gained from this study will help to advance this work.

Biogen has provided a statement to our PSP community, which we share below:

In response to your information request regarding Biogen’s study in progressive supranuclear palsy (PSP) called PASSPORT please find below a summary of the top-line study results.

Study Results

Biogen is disappointed to discontinue development of gosuranemab in PSP. The study results did not show any significant difference between people taking the investigational drug versus those taking the placebo as measured by the PSP Rating Scale (PSPRS), the primary measurement of the study. PSPRS measures the disability and severity of PSP.  The decision to discontinue development of gosuranemab in PSP was not based on safety concerns. Safety results of the PASSPORT study were generally consistent with previous studies of gosuranemab.

Background

PASSPORT, a Phase 2 clinical study, enrolled 490 people with PSP across 13 countries.  The study was 52-weeks long and aimed to learn about the safety and efficacy (if it works) of gosuranemab in people with PSP. It was a “double-blind” study which means that neither the participants nor their doctors knew whether the participants were on treatment or the placebo. The placebo looked like gosuranemab but had no active drug.

Biogen appreciates all those who participated in the study, their families and physicians. Detailed results of the PASSPORT study will be made available at a future scientific forum.

Any person with PSP or the caregiver of a person with PSP that has questions or concerns about the study should contact their healthcare professional.

The Biogen PSP Team

Study Results

Biogen is disappointed to discontinue development of gosuranemab in PSP. The study results did not show any significant difference between people taking the investigational drug versus those taking the placebo as measured by the PSP Rating Scale (PSPRS), the primary measurement of the study. PSPRS measures the disability and severity of PSP.  The decision to discontinue development of gosuranemab in PSP was not based on safety concerns. Safety results of the PASSPORT study were generally consistent with previous studies of gosuranemab.

Background

 PASSPORT, a Phase 2 clinical study, enrolled 490 people with PSP across 13 countries.  The study was 52-weeks long and aimed to learn about the safety and efficacy (if it works) of gosuranemab in people with PSP. It was a “double-blind” study which means that neither the participants nor their doctors knew whether the participants were on treatment or the placebo. The placebo looked like gosuranemab but had no active drug.

Biogen appreciates all those who participated in the study, their families and physicians. Detailed results of the PASSPORT study will be made available at a future scientific forum.

Any person with PSP or the caregiver of a person with PSP that has questions or concerns about the study should contact their healthcare professional.

The Biogen PSP Team