[{"orgOrder":0,"company":"Prilenia therapeutics","sponsor":"Morningside Venture","pharmaFlowCategory":"D","amount":"$62.5 million","upfrontCash":"Undisclosed","newsHeadline":"Prilenia Therapeutics Raises $62.5M to Fund Late Stage Trials In HD and ALS","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Prilenia therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia Enrolls First Patients Into its PROOF-HD Phase 3 Clinical Trial for Huntington\u2019s Disease in the United States","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prilenia Plans to Submit Marketing Authorization Application (MAA) in the EU for Pridopidine in Huntington\u2019s Disease","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"ISRAEL","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II\/ Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Prilenia therapeutics
TV-7820 (pridopidine) is an oral, highly selective and potent investigational S1R agonist, which is being evaluated as a potential treatment for Huntington’s disease.
Pridopidine is an investigational oral, small molecule, highly selective and potent Sigma-1 Receptor (S1R) agonist which is being evaluated as a potential treatment for ALS and Huntington’s disease (HD).
Pridopidine is an oral, highly selective S1R agonist which stimulates multiple cellular pathways, including autophagy, which are essential to neuronal function and survival, and may lead to neuroprotective effects.
Pridopidine is an oral, highly selective S1R agonist which stimulates multiple cellular pathways, including autophagy, which are essential to neuronal function and survival, and may lead to neuroprotective effects.
Fast Track accelerate the registration process for pridopidine by providing the ability to file a rolling NDA and qualify for priority review, and administered orally acts as a highly selective and potent Sigma-1 Receptor agonist is for HD and ALS.
The proceeds will be used to prepare for potential registration and commercialization of its lead drug candidate, pridopidine, for patients with Huntington’s Disease (HD) and Amyotrophic Lateral Sclerosis (ALS).
Pridopidine is currently being assessed in the HEALEY ALS Platform Trial in the U.S., the first for ALS. The pridopidine regimen enrolled its first participant in January 2021 and is on track to generate results in H2 2022.
The trial is investigating Prilenia’s lead candidate, pridopidine, for treatment of Huntington’s Disease. The study reached 25% in May 2021 and enrolled a further 25% in only six weeks, with now over 240 registered early-stage HD patients.
Pridopidine is a potent and selective Sigma-1 receptor (S1R) agonist, currently being assessed in the HEALEY ALS Platform trial in the US; a multi-center, multi-regimen clinical study evaluating the safety and efficacy of investigational products for the treatment of ALS.
The study is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of pridopidine 45 mg bid in patients with early-stage HD. PROOF-HD, a Phase 3 clinical trial in Huntington’s Disease (HD), is currently recruiting in Europe.
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