Cassava’s Positive New Alzheimer’s Data Meets Lukewarm Reception
Cassava Sciences, which fell on controversial times just a few weeks ago, announced top-line results Wednesday from a 12-month interim analysis of its Alzheimer’s drug candidate simufilam.
Cassava reported that the first 50 study participants in the open-label study experienced improved cognition scores to the tune of 3.2 points on average from baseline on a 70-point ADAS-Cog scale. This was up from a 3-point improvement at the 9-month analysis, Cassava said. An additional 20% of participants held (almost) steady, declining at less than 5 points at an average of 2.5 points. In comparison, an independent, published meta-analysis of patients with mild to moderate Alzheimer’s showed an average decline of 5.5 points over 12 months. The participants in Cassava’s study also had mild to moderate Alzheimer’s disease. Simufilam was found to be well-tolerated.
“I feel energized and encouraged by the clinical data,” said Cassava President and CEO Remi Barbier. “We look forward to the initiation of a randomized, double-blind, placebo-controlled pivotal phase III clinical program with simufilam in people with Alzheimer’s disease.”
The company stated that this six-month pivotal Phase III trial remains on track to begin in Q4 of 2021. With these results, Cassava’s stock was expected to soar. However, the stock dipped by 1%. The open-label nature of the study—where the patients know they are receiving the drug—could have played into this. While no placebo was used in this study, Cassava plans to use one in the aforementioned Phase III study.
Investors could also still have been smarting from allegations levied in August by Labaton Sucharow that some of Cassava’s results appeared to show signs of data manipulation.
“This report raises concerns about the quality and integrity of the laboratory-based studies surrounding this drug candidate,” wrote Jordan Thomas, partner and chair of Labaton Sucharow’s whistleblower representation practice. “The volume of problematic material uncovered in publicly available sources indicates a thorough audit would likely unveil significant additional scientific misconduct and data manipulation.”
Thomas added that “the methodology allegedly used in these experiments defies logic” and requested that the U.S. Food and Drug Administration (FDA) halts Cassava’s clinical trials.
Among Thomas’s top issues were what he called Cassava’s “extensive use of Western blot analysis” in its research and biomarker data.
In response, Cassava pointed to plasma p-tau data it claimed was generated by Lynn A. Brunelle of diagnostics company Quanterix Corp., which is presented at the 2021 Alzheimer’s Association International Conference. Quanterix quickly denied that it was directly involved in generating this data.
At the time of the complaint, Barbier told BioSpace that he had “never heard of a Citizen’s Petition for a pre-phase III drug, especially on a drug candidate that appears to be as safe as simufilam.”
In its statement yesterday, Cassava emphasized the impartiality of the 12-month interim analysis, stating that the changes in the ADAS-Cog scores were independently analyzed by two consulting biostatisticians.
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