Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company developing product candidates for Alzheimer’s disease, today announced significant program progress and expected milestones for 2021.
“We started 2021 with tremendous momentum, led by results of a 6-month interim analysis from an open-label study of simufilam, our drug candidate for Alzheimer’s disease,” said Remi Barbier, President & CEO. “I believe the rest of the year may be equally exciting.”
Cassava Sciences’ strategic focus for 2021 is to advance simufilam in a Phase 3 clinical program in Alzheimer’s disease, to expand drug manufacturing capabilities in support of the clinical program, and to continue to lead the Company to deliver the full potential of its product portfolio.
Cassava Sciences’ 2021 Scientific and Clinical OutlookCassava Sciences’ product portfolio includes a small molecule drug for the treatment of Alzheimer’s disease, called simufilam, and an investigational blood-based diagnostic to detect and monitor the progression of Alzheimer’s disease, called SavaDx.
Expected progress and key milestones in 2021 across Cassava Sciences’ product portfolio are summarized below.
- Based on recent positive clinical results and inbound demand from clinical sites, patients, and their caregivers, Cassava Sciences plans to expand the size of the ongoing open-label study of simufilam. The target enrollment will be increased by up to 50 additional patients with mild-to-moderate Alzheimer’s disease, for a total target enrollment of up to 150 patients.
- Cassava Sciences has enrolled approximately 80 patients in the open-label study to date. To accommodate increased enrollment, the Company plans to open new clinical sites across the U.S. and Canada.
- Cassava Sciences expects to announce results of a second interim analysis of the ongoing open-label study when approximately 50 patients complete 12 months of drug treatment. This second interim analysis is expected to include clinical data around long-term safety, cognition and Alzheimer’s-related behavior.
- Cassava Sciences plans to initiate a 6-month, double-blind, randomized, placebo-controlled study in patients with Alzheimer’s disease who complete at least one year of open-label treatment with simufilam. This is a Cognition Maintenance Study (CMS), in which patients who complete one year of open-label treatment will subsequently be randomized (1:1) to simufilam or placebo for six months. The CMS is designed to compare simufilam’s effects on cognition and behavior in patients who continue with drug treatment versus those who discontinue drug treatment. For ethical and other reasons, patients who successfully complete the six-month CMS will have the option to receive open-label simufilam.
- Cassava Sciences’ clinical and regulatory strategy for simufilam is progressing as planned. In January 2021, the Company concluded a successful End-of-phase 2 (EOP2) meeting with the U.S Food and Drug Administration (FDA). The purpose of the EOP2 was to gain general agreement around a Phase 3 program to treat Alzheimer’s disease dementia.
- As a result of the EOP2 meeting, Cassava Sciences believes its clinical program for simufilam is green-lighted to commence a large, Phase 3 clinical program in patients with Alzheimer’s disease, pending official FDA meeting minutes of the EOP2 meeting.
- Cassava Sciences plans to initiate a Phase 3 program of simufilam in Alzheimer’s disease in the second half of 2021.
- Cassava Sciences’ Phase 3 program for simufilam consists of two large, double-blind, randomized, placebo-controlled studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. The Company expects to announce details of its Phase 3 program in Q1 2021, pending official FDA meeting minutes of the EOP2 meeting.
- Cassava Sciences’ first Phase 3 study will evaluate disease-modifying effects in Alzheimer’s disease patients over 18 months. The goal of this study is to show a slower rate of decline in cognition and daily function in patients treated with simufilam, compared to patients treated with placebo.
- Cassava Sciences’ second Phase 3 study will evaluate symptomatic improvement in Alzheimer’s disease patients over 6 months. The goal of this study is to show improvement in cognition and daily function in patients treated with simufilam, compared to patients treated with placebo.
- Cassava Sciences believes its manufacturing strategy is on-track to ensure sufficient drug supply for a Phase 3 program, including both drug substance (i.e., active ingredient) and drug product (i.e., oral tablets).
- Cassava Sciences expects to conclude a long-term, commercial drug supply agreement for simufilam with a contract manufacturing organization. The goal is to ensure the integrity of the drug supply chain on a worldwide basis, in compliance with FDA standards.
- Cassava Sciences expects to initiate a validation study with SavaDx, its investigational diagnostic for the detection of Alzheimer’s disease.
- Cassava Sciences is in discussions with scientific and clinical advisors about potentially expanding therapeutic indications for simufilam outside of Alzheimer’s disease, but still within neurodegenerative conditions.
Other Expected Milestones and Announcements for 2021
- Cassava Sciences expects to announce publication of Phase 2b results in a peer-reviewed technical journal.
- Net cash use for full-year 2021 is expected to be in the range of $20 to $25 million, depending on enrollment rates in its clinical programs and other factors. On December 31, 2020, unaudited cash and cash equivalents were approximately $93 million.