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[{"company":"GemVax & KAEL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Promising Phase II Results Underpin GemVax Decision to Apply for Expanded Access IND for GV1001 in Alzheimer's Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Peptide","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Peptide","graph2":"GemVax & KAEL"},{"company":"GemVax & KAEL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GemVax & Kael Reports Further Positive Data from GV1001 Phase II Alzheimer's Disease Trial","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Peptide","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Peptide","graph2":"GemVax & KAEL"},{"company":"GemVax & KAEL","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GemVax's Highly Promising Phase II Alzheimer's Disease Clinical Trial Results Published in Prestigious Alzheimer's Research & Therapy' journal","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Peptide","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Peptide","graph2":"GemVax & KAEL"},{"company":"Bio-Pharm Solutions","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bio-Pharm Solutions Expands from Epilepsy to Neurodegenerative Diseases Aiming for IPO","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Bio-Pharm Solutions"},{"company":"AriBio","sponsor":"SK Chemicals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AriBio Announces Completion of Enrollment in Phase 2 Alzheimer\u2019s Study with AR1001","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AriBio"},{"company":"AriBio","sponsor":"Cleveland Clinic","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"The Potential of PDE5 Inhibitors, Such as AriBio\u2019s AR1001, the Lead Clinical Candidate for Alzheimer\u2019s Disease, Confirmed in a Recent Independent Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AriBio"},{"company":"AriBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AriBio Co., Ltd. Announces the Successful Completion of Their End of Phase 2 Meeting With the USFDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"SOUTH KOREA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AriBio"}]

AriBio

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AriBio Co., Ltd. Announces the Successful Completion of Their End of Phase 2 Meeting With the USFDA

Details:

Pre-clinical studies have confirmed neuroprotective effects of AR1001 via inhibiting neuron apoptosis and restoring synaptic plasticity, also has demonstrated notable effects against amyloid plaques and tau proteins via autophagy activation.

Lead Product(s): Methylbenzylamine

Therapeutic Area: Neurology Product Name: AR1001

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2022

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AriBio

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The Potential of PDE5 Inhibitors, Such as AriBio’s AR1001, the Lead Clinical Candidate for Alzheimer’s Disease, Confirmed in a Recent Independent Study

Details:

Positive Phase II trial reported for AR1001, the results confirmed the possibility of developing a unique oral disease-modifying treatment for AD that improves cognitive function. The Company will complete Phase III clinical trials of AR1001 within the next 3-4 years.

Lead Product(s): Methylbenzylamine

Therapeutic Area: Neurology Product Name: AR1001

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Cleveland Clinic

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 20, 2021

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GemVax & KAEL

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GemVax's Highly Promising Phase II Alzheimer's Disease Clinical Trial Results Published in Prestigious Alzheimer's Research & Therapy' journal

Details:

The paper is titled 'Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer's already receiving donepezil and contains an analysis of the overall data from the Phase II clinical trial for Alzheimer's disease conducted in Korea.

Lead Product(s): Tertomotide

Therapeutic Area: Neurology Product Name: GV1001

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 30, 2021

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GemVax & KAEL

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GemVax & Kael Reports Further Positive Data from GV1001 Phase II Alzheimer's Disease Trial

Details:

GemVax's GV1001 Phase II trial evaluated the safety and efficacy of subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients with moderate-to-severe Alzheimer's disease already receiving donepezil for more than three months, at 12 medical institutions.

Lead Product(s): Tertomotide

Therapeutic Area: Neurology Product Name: GV1001

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 23, 2020

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GemVax & KAEL

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Promising Phase II Results Underpin GemVax Decision to Apply for Expanded Access IND for GV1001 in Alzheimer's Disease

Details:

The pivotal decision is based on an encouraging recent analysis of results from a Phase II trial of GV1001, completed last year in Korea and if granted would apply to a second Phase IIb trial in the US now planned for early 2021.

Lead Product(s): Tertomotide

Therapeutic Area: Neurology Product Name: GV1001

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 06, 2020

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AriBio

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AriBio Announces Completion of Enrollment in Phase 2 Alzheimer’s Study with AR1001

Details:

AriBio completed enrollment in a Phase 2 study of AR1001, a first in class, orally dosed investigational drug for mild to moderate Alzheimer’s disease.

Lead Product(s): Methylbenzylamine

Therapeutic Area: Neurology Product Name: AR1001

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: SK Chemicals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

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Bio-Pharm Solutions

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Bio-Pharm Solutions Expands from Epilepsy to Neurodegenerative Diseases Aiming for IPO

Details:

The oral medication for Infantile spasms (IS) is in phase 2 clinical trials in Korea and the US, and the IV medication for Status epilepticus (SE) is in phase 1 clinical trials in the US.

Lead Product(s): JBPOS0101

Therapeutic Area: Neurology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 26, 2020

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