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DGAP-News: MorphoSys AG / Key word(s): Study
Planegg/Munich, Germany, March 14, 2018
Clinical Data Presentations at AAT in Alzheimer's Disease Support Investigating Gantenerumab in Higher Doses in New Pivotal Phase 3 Trials
- Three abstracts will be presented at the upcoming Alzheimer's and Parkinson's Disease conference AAT-AD/PDTM Focus Meeting 2018, thereof one as Late Breaking Abstract.
- Gantenerumab showed greater and consistent amyloid beta reduction in the brain after one year of treatment at higher doses in open label extension (OLE) clinical studies in patients with prodromal to mild Alzheimer's disease compared to lower dosing.
- Results from clinical OLE trials supported higher dosing up to 1200 mg in a slowup-titration regimen compared to doses of 105 mg and 225 mg previously tested in clinical studies.
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that clinical data supporting the application of gantenerumab in higher doses in new pivotal phase 3 studies for the treatment of Alzheimer's disease planned to start later this year will be presented at AAT-AD/PDTM. In the data presented, gantenerumab was evaluated with considerably higher doses in an open label extension (OLE) study part than previously tested.
A total of three different abstracts for gantenerumab including one Late Breaking Abstract were accepted for presentation at the upcoming Alzheimer's and Parkinson's Disease conference AAT-AD/PDTM Focus Meeting 2018, which is a new joint meeting between the International Geneva/Springfield Symposium on Advances in Alzheimer Therapy and AD/PDTM, to be held from March 15-18 in Torino, Italy. Gantenerumab is a monoclonal antibody directed against amyloid beta (Aβ) developed by Roche for the treatment of Alzheimer's disease that was generated by MorphoSys using its proprietary HuCAL technology.
"The effect of higher doses of gantenerumab on the reduction of amyloid beta in Alzheimer's patients is very encouraging to us", commented Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG.
In the abstract accepted for presentation during the Late Breaking session at the AAT-AD/PDTM, clinical data will be presented assessing clinical effects of higher doses of gantenerumab measured by amyloid beta reduction in the brain. 81 patients with prodromal to mild Alzheimer's disease were enrolled in the OLE study parts and received higher doses of up to 1200 mg gantenerumab subcutaneously every 4 weeks. The dose increase, from starting levels of 105 mg or 225 mg of gantenerumab to up to 1200 mg, was administered using different titration schemes with the goal of controlling potential safety findings due to the increased doses. 51 patients had a brain positron emission tomography (PET) scan to determine amyloid plaques at week 52. According to the data presented, patients who received higher doses of gantenerumab showed a greater and consistent amyloid reduction compared to patients having received lower dosing (105 mg or 225 mg). At week 52, approximately one third of the high-dose patients had amyloid levels below the threshold that classifies a patient as amyloid beta positive.
Review of the data in the OLE studies did not reveal any new or unexpected safety findings of the higher doses for this patient population. As reported previously (Andjelkovic et al., 2017, CTAD abstract), increased doses of gantenerumab led to an increase of ARIA (amyloid-related imaging abnormalities), which, however, remained manageable with the implemented dosing titration scheme. In the higher doses of up to 1200 mg, severity and seriousness of adverse events was comparable to the lower doses (105 mg or 225 mg) applied in the previous studies.
Abstract / Oral presentation- Optimizing the Gantenerumab Phase 3 Dosing Regimen Through PK/PD Modeling and Clinical Trial Simulations
Abstract / Oral presentation- The Effect of Speed of Injection on Pain, Tolerability, Safety and Pharmacokinetics Following SC Administration of Gantenerumab
HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys Group.
MorphoSys forward looking statements
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Document title: Press Release
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