Cassava Sciences Discontinues Creating Simufilam For Alzheimer’s After One other Section 3 Trial Flop – Cassava Sciences (NASDAQ:SAVA)

Cassava Sciences Inc. SAVA on Tuesday shared topline outcomes from the Section 3 REFOCUS-ALZ examine of simufilam in mild-to-moderate Alzheimer’s illness.

REFOCUS-ALZ randomized roughly 1,125 individuals using the identical eligibility standards as RETHINK-ALZ.

Topline information point out that REFOCUS-ALZ didn’t meet every of the prespecified co-primary, secondary and exploratory biomarker endpoints.

Additionally Learn: Cassava Sciences Alzheimer’s Drug Fails To Hit Main Purpose In Pivotal Research, Pharma Halts Late-Stage Research

The co-primary endpoints had been the change in cognition and performance from baseline to the top of the double-blind therapy interval at week 76, assessed by the ADAS-COG12 and ADCS-ADL scales, evaluating simufilam to placebo.

On ADAS-COG12 (cognitive scale, the place decrease numbers imply much less cognitive impairment), scores rose by 4.97 and 5.26 factors within the two simufilam cohorts and by 4.70 factors within the placebo group.

Equally, on ADCS-ADL (each day residing the place the next quantity represents much less purposeful impairment), scores fell by 6.27 and 6.43 factors on simufilam arms and by 5.32 factors on placebo. 

REFOCUS-ALZ was discontinued in November following the report {that a} prior 52-week Section 3 examine, RETHINK-ALZ, didn’t meet its co-primary endpoints.

A big portion of topics enrolled in REFOCUS-ALZ accomplished their closing examine go to previous to the termination of the trial. Simufilam continued to display an total favorable security profile.

“We’re upset that the outcomes of REFOCUS-ALZ and RETHINK-ALZ confirmed no therapy profit for sufferers with mild-to-moderate Alzheimer’s illness. These outcomes had been unambiguous,” stated Cassava Chief Government Rick Barry.

“Cassava will discontinue all efforts to develop simufilam for Alzheimer’s illness and we anticipate to section out this system by the top of Q2 2025,” Barry continued.

In February, Cassava Sciences entered into an settlement with Yale College for a license to mental property rights, together with an unique license to an issued US methodology of therapy patent for simufilam as a possible therapy for seizures associated to uncommon neurodevelopmental issues, together with tuberous sclerosis complicated.

Worth Motion: SAVA inventory is down 22.1% at $2.18 on the final examine Tuesday.

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