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Details:

SLS-005 (trehalose), a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy. It is being evaluated for the treatment of amyotrophic lateral sclerosis.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 19, 2024

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Novos vital is a groundbreaking supplement chew scientifically formulated with an ingredient blend shown to support and optimize essential organ functions that decline with age.


Lead Product(s): Trehalose API,Nattokinase,Rutin

Therapeutic Area: Cardiology/Vascular Diseases Product Name: Novos Vital

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 21, 2024

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SLS-005 (trehalose) is a low molecular weight disaccharide that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression.


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 25, 2022

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Details:

SLS-005 (trehalose injection), is low molecular weight disaccharide that crosses BBB and is thought to stabilize proteins and activate autophagy through activation of Transcription Factor EB, a key factor in lysosomal and autophagy gene expression.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 18, 2022

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Details:

SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 08, 2022

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In in-vivo studies of ALS, trehalose has been shown to increase the clearance of TDP-43, decrease SOD1 and SQSM1/p62 aggregates and monomers, delay the progression of the disease, preserve ventral horn motor neurons and increase muscle fiber size.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

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 November 10, 2021

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Details:

SLS-005 (Trehalose) is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier, stabilizes proteins and, importantly, activates autophagy used for treatment of amyotrophic lateral sclerosis (ALS).


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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 27, 2021

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Details:

Seelos Therapeutics has received a positive opinion on European Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

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 April 20, 2021

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Details:

Janssen will provide drug supply for the clinical trials and Extended Access Program, and right of reference to data within the Zavesca New Drug Application (NDA) to support the development of BBDF-101.


Lead Product(s): Miglustat,Trehalose API

Therapeutic Area: Genetic Disease Product Name: BBDF 101

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Beyond Batten Disease Foundation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 02, 2021

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Details:

Seelos Therapeutics has received a Notice of Allowance from the Japanese Patent Office covering SLS-005 titled: "Treatment of Protein Aggregation Myopathic and Neurodegenerative Diseases by Parenteral Administration of Trehalose".


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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 22, 2021

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Seelos has been granted Orphan Drug Designation for SLS-005 in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) from U.S. FDA. Seelos' Phase IIb/III trial plans to enroll 160 patients with either familial or sporadic ALS in a double-blind placebo-controlled trial.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

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 November 19, 2020

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This online conference will bring together participants from all over the world including academics, clinicians and professors, managements of public and private biotechnology companies, as well as families with children affected by these diseases.


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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 November 09, 2020

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The allowed claims cover a method of using trehalose (SLS-005) to treat several neurodegenerative conditions including spinocerebellar ataxia, spinal and bulbar muscular atrophy, dentatomral-pailidoluyssan atrophy, Pick's disease, corticobasaldegeneration (CBD) etc.


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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 10, 2020

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Seelos Therapeutics has been granted Orphan Drug Designation (ODD) for SLS-005 in mucopolysaccharidosis type III (MPS III), Sanfilippo syndrome, from the European Medicines Agency (EMA).


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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 25, 2020

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Details:

In in-vivo studies of ALS, trehalose has been shown to increase clearance of TDP-43, decrease SOD1 and SQSM1/p62 aggregates and monomers, delay the progression of the disease, preserve ventral horn motor neurons and increase muscle fiber size.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: SLS-005

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 10, 2020

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Details:

Seelos Therapeutics has received a positive opinion on European Orphan Drug Designation for SLS-005 in Sanfilippo syndrome from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease Product Name: SLS-005

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, 2020

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Details:

Seelos has been granted Rare Pediatric Disease Designation (RPDD) for SLS-005 in Sanfilippo syndrome from the U.S. Food and Drug Administration (FDA).


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease 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

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Details:

The allowed claims cover the composition of matter and method of use for trehalose (SLS-005) for treating diseases or disorders which include Spinal and bulbar muscular atrophy (SBMA) and other.


Lead Product(s): Trehalose API

Therapeutic Area: Neurology Product Name: Undisclosed

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 04, 2020

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SLS-005 was previously granted Orphan Drug Designation from the FDA and EMA for Spinocerebellar Ataxia Type 3 and Oculopharyngeal Muscular Dystrophy as well as Fast Track designation for OPMD.


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease 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 April 30, 2020

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Details:

Seelos seeks scientific advice and protocol assistance for a European clinical study of SLS-005 in patients with Sanfillipo syndrome type A and B from EMA.


Lead Product(s): Trehalose API

Therapeutic Area: Genetic Disease 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 22, 2020

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