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.
PLANEGG/MUNICH, GERMANY /ACCESSWIRE / March 14, 2018 / MorphoSys AG (XETRA: MOR); (FSE: MOR); Prime Standard Segment, TecDAX; (OTC PINK: 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. Eighty-one (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. Fifty-one (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.
Details of the presentations about gantenerumab at the AAT-AD/PDTM 2018
Abstract / Oral (Late Breaker) - Analysis of Factors and Methodologic Considerations Affecting Plaque Reduction Measures via PET in the Gantenerumab Open-Label Extension Studies
Symposium LB1 - Clinical trials in AD, PD, and progressive supranuclear palsy
Date: Thursday, March 15, 2018
Time: 10:40 AM - 11:00 AM CET
Place: Sala 500
Presenter: Greg Klein
Abstract / Oral presentation- Optimizing the Gantenerumab Phase 3 Dosing Regimen Through PK/PD Modeling and Clinical Trial Simulations
Symposium 13 - Anti-amyloid Immunotherapies
Date: Friday, March 16, 2018
Time: 4:05 PM - 4:25 PM CET
Place: Sala 500
Presenter: Carsten Hofmann
Abstract / Oral presentation- The Effect of Speed of Injection on Pain, Tolerability, Safety and Pharmacokinetics Following SC Administration of Gantenerumab
Symposium 13 - Anti-amyloid Immunotherapies
Date: Friday, March 16, 2018
Time: 4:25 PM - 4:45 PM CET
Place: Sala 500
Presenter: Agnes Porton
About MorphoSys
MorphoSys is a late-stage biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on our proprietary technology platforms and leadership in the field of therapeutic antibodies, we, together with our partners, have participated in the development of more than 100 therapeutic product candidates currently in R&D, 28 of which in clinical development. Our broad pipeline spans two business segments: Proprietary Development, in which we invest in and develop product candidates, and Partnered Discovery, in which we generate product candidates for our partners in the pharmaceutical and biotechnology industries against targets identified by our partners. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.
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.
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MorphoSys AG
Jochen Orlowski
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Alexandra Goller
Associate Director Corporate Communications & IR
Tel: +49 (0) 89 / 899 27-404
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SOURCE: MorphoSys AG