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The SPARK study analyzed the efficacy of the anti-α-syn monoclonal nuclear protein (syn) monoclonal antibody cimpanemab reducing injury and disability in Parkinson's patients compared to a placebo, with the main endpoint being an improvement in the total score of MDS-UPDRS.
hope the drug will successfully compete with Roche and Prothena's syn therapy prasinezumab.
the development of cipanemab has been halted because the treatment "does not achieve proof-of-concept" and does not provide benefits to patients in the study.
s decision was made in February 2021 and is based on the results of a study as of December 31, 2020," Mr. Yan said in a statement.
We have identified approximately $75.4 million in impairment charges for the drug's development in the fourth quarter of 2020, reducing the fair value of the intangible assets associated with the product development process (IPR and D) to zero.
, we will apply what we have learned to future research on Parkinson's disease.
added: "The value of the drug-related or adjuvant debt has been adjusted, which has resulted in a financial gain of $51 million in the fourth quarter of 2020."
" was obtained in 2016 from biotech company Neurimmune and then entered early research into Parkinson's disease.
2018, Yan Jian outlined the design of phase 2 clinical study SPARK and said the study was the most advanced project in the company's Research Drug Pipeline for Parkinson's disease at the time.
but with the abandonment of cipanemab, Yan Jian will continue to shift its focus to its Alzheimer's drug aducanumab.
the drug, developed in cooperation with Japan's Eisai, has been mired in controversy since it entered late-stage research, and in late January the U.S. Food and Drug Administration (FDA) extended the review period of the Aducanumab Bio-License Application (BLA).
FDA had expected a decision on the drug's listing application on March 7, but that decision was delayed until June 7 to weigh the data further.
source: Biogen Ditches Parkinson's Drug After Phase II Study Fails to Show Benefit
