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Details:
Evonik to supply commercial quantities of simufilam, a drug candidate for the treatment of Alzheimer’s disease. Simufilam is a novel drug, discovered at Cassava Sciences, that targets both neuroinflammation and neurodegeneration.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cassava Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 09, 2021
Details:
PTI-125 (simufilam) is a novel small molecule drug candidate that binds to altered filamin A protein in the brain and restores its normal shape and function. It is being evaluated for the treatment ofAlzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2024
Details:
PTI-125 (simufilam) is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. It binds to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2023
Details:
PTI-125 (simufilam) is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. It binds to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2023
Details:
PTI-125 (simufilam) is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. It binds to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2023
Details:
PTI-125 (simufilam) is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. It binds to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2023
Details:
PTI-125 (simufilam) is a novel drug candidate designed to treat and slow the progression of Alzheimer’s disease. It binds to an altered conformation of the filamin A protein (FLNA) that is present in the brain of the Alzheimer’s patient and is critical to the toxicity of Aβ42.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2023
Details:
PTI-125 (simufilam) is Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Currently being developed for alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Oncology Product Name: PTI-125
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2023
Details:
PTI-125 (simufilam) is a small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Currently being investigated for alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
Details:
PTI-125 (simufilam) is Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Currently being developed for alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
PTI-125 (simufilam) is a small molecule (oral) drug candidate that restores the normal shape and function of altered filamin a (flna) protein in the brain. it is currently being investigated as a potential treatment for alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2023
Details:
PTI-125 (simufilam) is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2022
Details:
Cassava Sciences intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of simufilam, the Company’s lead drug candidate for the treatment of Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 22, 2022
Details:
Cassava Sciences intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of PTI-125 (simufilam), the Company’s lead drug candidate for the treatment of Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 18, 2022
Details:
PTI-125 (Simufilam) is Cassava Sciences’ proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
New clinical website provides rethinkALZ and refocusALZ studies intended to provide access, visibility and information on Cassava Sciences’ Phase 3 safety and efficacy studies of oral simufilam in people with Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 23, 2021
Details:
Cassava Sciences is developing simufilam in accordance with high ethical standards and sound scientific principles. The second Phase 3 study, called REFOCUS-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2021
Details:
Simufilam (formerly known as PTI-125) is an investigational and proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain to treat Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA) protein in the brain for treatment of Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2021
Details:
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain used in patients with mild-to-moderate Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
These SPA agreements document that FDA has reviewed and agreed upon the key design features of Cassava Sciences’ Phase 3 study protocols of simufilam for the treatment of patients with Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2021
Details:
Additionally, simufilam 100 mg and 50 mg reduced plasma levels of p-tau181 by 17% (p=0.01) and 15% (p=0.02) respectively, versus placebo. Plasma p-tau181 is a biomarker that is known to be elevated in Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2021
Details:
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that restores the normal shape and function of altered filamin A (FLNA), a scaffolding protein, in the brain.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
Premier Research International as its clinical research organization (CRO) to help conduct the Phase 3 clinical program of simufilam for Alzheimer’s disease. Consistent with previous guidance, Cassava Sciences plans to initiate Phase 3 program in the second half of 2021.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
This research grant is intended to fund clinical readiness activities in support of Cassava Sciences’ upcoming Phase 3 program with simufilam, its drug candidate for Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $2.7 million Upfront Cash: Undisclosed
Deal Type: Funding May 12, 2021
Details:
Cassava Sciences intends to use the net proceeds, if any, from this offering for working capital and general corporate purposes, including development of simufilam, the Company’s lead drug candidate for the treatment of Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 10, 2021
Details:
In a clinical study funded by the National Institutes of Health and conducted by Cassava Sciences, six months of simufilam treatment improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2021
Details:
In Q2 2020, Cassava Sciences completed a double-blind, randomized, placebo-controlled study of PTI-125 in patients with mild-to-moderate Alzheimer’s disease (N=64).
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: PTI-125
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020
Details:
Cassava Sciences believes high variability in levels of biomarkers over 28 days in placebo-treated patients, and other possible factors, may drive a reassessment of overall results for its Phase 2b randomized, placebo-controlled study of PTI-125 in Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
This study did not meet its primary endpoint. The pre-specified primary endpoint was a statistically significant effect of PTI-125 versus placebo on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments from baseline to Day 28.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
Grant will support an on-going clinical evaluation of lead investigational drug PTI-125 in alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $2.5 million Upfront Cash: Undisclosed
Deal Type: Funding April 23, 2020
Details:
A total of 64 patients were enrolled in a randomized, double-blind, placebo-controlled, Phase 2b study of PTI-125, Cassava Sciences’ investigational drug to treat Alzheimer’s disease.
Lead Product(s): Simufilam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2020
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