segunda-feira , 4 julho 2022
Capa » International News » Cassava’s simufilam still has further hurdles to face in securing a solid position in the Alzheimer’s disease market

Cassava’s simufilam still has further hurdles to face in securing a solid position in the Alzheimer’s disease market

says GlobalData

Cassava Sciences recently announced that the Food and Drug Administration (FDA) had denied a Citizen Petition and associated supplements filed by investors questioning the credibility of positive data from the company’s Phase IIb trial (NCT04079803) of late-stage Alzheimer’s disease (AD) asset, simufilam. Despite this win for the company, simufilam still has further hurdles to face in securing a solid position in the AD market, says GlobalData, a leading data and analytics company.

In August 2021, the Citizen Petition was filed by an attorney on behalf of a few investors who doubted the veracity of reported results from Cassava’s Phase IIb trial of simufilam; in particular, the company was accused of manipulating the figures of the Western blot data. Therefore, the investors asked the FDA to halt the planned Phase III trials of the drug in AD.

Sarah Elsayed, Neurology Analyst at GlobalData, comments: “The FDA denying the Citizen Petition was a relief for Cassava and immediately boosted the company’s shares, which provided a much-needed upturn after extreme fluctuations over the past year. Moreover, Cassava is now moving forward with two pivotal Phase III trials, RETHINK-ALZ (NCT04994483) and REFOCUS-ALZ (NCT05026177), which further assess the safety and efficacy of simufilam in the treatment of mild and moderate AD. GlobalData estimates that simufilam will launch in the US in Q2 2026 if positive results are achieved in Phase III trials.”

The anticipated competition from numerous late-stage pipeline candidates, coupled with Cassava’s small size and lean commercial capabilities to penetrate the market, will likely limit the uptake of simufilam. As such, the entry of simufilam will have a modest impact on the AD market, and the drug will reach sales of $553.7 million in the US by 2030, according to GlobalData’s report, ‘Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2028’.

Elsayed continues: “Although the allegations of data manipulation have been disproven for now, concerns remain that this type of controversy will have lasting impacts on the company’s image and limit the drug’s performance in the market. This view is supported by a US key opinion leader (KOL) previously interviewed by GlobalData, who mentioned that they mainly knew about simufilam in the context of the data-misreporting debate.”

Compounded with increased scrutiny of therapies targeting amyloid, due to the ongoing controversy surrounding Biogen and Eisai’s anti-amyloid monoclonal antibody (mAb), Aduhelm (aducanumab), Cassava will need to be strategic in its marketing plans going forward.

Elsayed adds: “The company will also need to contend with strong competition from other late-stage pipeline candidates including anti-amyloid beta mAbs such as Roche’s gantenerumab and Lilly’s donanemab, in addition to other oral agents such as Alzheon’s ALZ-801 (valiltramiprosate), which also targets amyloid. As such, it may be crucial for the company to seek partnerships and licensing deals with more established companies to support its promotional and manufacturing activities before the full market potential of simufilam can be reaped.”

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