Potential Parkinson’s Therapy ABBV-0805 Enters Phase 1 Testing in Healthy Volunteers

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by Alice Melão |

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AbbVie has launched a Phase 1 trial in the United States to assess the safety and tolerability of an investigational antibody targeting alpha-synuclein called ABBV-0805 in healthy volunteers.

This study comes after the U.S. Food and Drug Administration approved an investigational new drug application for ABBV-0805 in February.

Findings of this initial Phase 1 trial will provide critical information for the design and progression of future clinical studies on this antibody as a potential disease-modifying treatment for patients with Parkinson’s disease.

Formerly known as BAN0805, ABBV-0805 was initially engineered and developed by BioArctic. It is a monoclonal antibody designed to specifically bind and destroy toxic aggregates of alpha-synuclein protein, which are known to contribute to the development of Parkinson’s disease.

In preclinical studies, this investigational antibody effectively decreased the levels of alpha-synuclein clumps by 65% compared with placebo. In addition, treatment with ABBV-0805 also delayed disease progression, reduced Parkinson’s-associated motor symptoms, and improved overall survival in a mouse model of Parkinson’s disease.

BioArctic and AbbVie established a strategic collaboration agreement in 2016 for the further development and future marketing rights on BioArctic’s portfolio of antibodies directed against alpha-synuclein.

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More recently, in December 2018, AbbVie exercised its option to acquire full rights over ABBV-0805. The company is now responsible for the clinical program and regulatory approval of the new antibody as a treatment for Parkinson’s and other potential indications.

“It is gratifying that our partner AbbVie has started the first clinical trial, a Phase 1 study, with ABBV-0805,” Gunilla Osswald, PhD, CEO of BioArctic, said in a press release. “We are now looking forward to ABBV-0805 moving forward in the clinical program and developing into a therapy with the potential to provide meaningful advances for patients with Parkinson’s disease.”

BioArctic will continue to develop other potential therapies targeting misfolded and abnormal proteins linked to Parkinson’s disease in the continued collaboration with AbbVie.

“I am looking forward to continuing the successful partnership with the ambition to deliver a new innovative disease modifying treatment to improve the quality of life for the large number of patients with Parkinson’s disease,” Osswald said in a previous press release.

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