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SPI-1005 is a new drug that contains ebselen, a selenorganic compound that mimics and induces glutathione peroxidase activity and is effective in reducing neuroinflammation across the CNS and PNS. It is being developed for meniere’s disease involving hearing loss, etc.
Lead Product(s): Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPI-1005
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 03, 2023
Details:
SPI-1005 is investigational drug that contains ebselen, a small molecule that is new chemical entity, under FDA classification. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase activity and represents novel class of anti-inflammatory.
Lead Product(s): Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPI-1005
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 28, 2022
Details:
SPI-1005 (ebselen) is a novel class of anti-inflammatory compound with Glutathione Peroxidase (GPx) activity and has been tested in more than 450 patients in six completed randomized controlled trials and in four ongoing studies in the US and UK.
Lead Product(s): Ebselen
Therapeutic Area: Infections and Infectious Diseases Product Name: SPI-1005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Center for Advancing Translational Sciences
Deal Size: $4.2 million Upfront Cash: Undisclosed
Deal Type: Funding May 11, 2022
Details:
SPI-1005 is an oral capsule containing ebselen, a small molecule with novel anti-inflammatory properties being developed for several neurotologic, neuropsychiatric, and respiratory indications.
Lead Product(s): Ebselen
Therapeutic Area: Infections and Infectious Diseases Product Name: SPI-1005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Center for Advancing Translational Sciences
Deal Size: $3.1 million Upfront Cash: Undisclosed
Deal Type: Funding April 06, 2021
Details:
SPI-1005 is an investigational new drug that contains ebselen, a novel small molecule that mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney.
Lead Product(s): Ebselen
Therapeutic Area: Infections and Infectious Diseases Product Name: SPI-1005
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 31, 2020
Details:
In the initial safety and exploratory efficacy studies, two different oral doses of SPI-1005 (400 and 800 mg, twice daily) will be tested and compared to placebo over a 30-day period of follow-up.
Lead Product(s): Ebselen
Therapeutic Area: Infections and Infectious Diseases Product Name: SPI-1005
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 30, 2020
Details:
SPI's clinical data from two completed multi-center, randomized, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) showed that oral delivery of SPI-1005 for 21 or 28 days improved sensorineural hearing loss and tinnitus in patients affected by MD.
Lead Product(s): Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed
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 June 08, 2020
Details:
The study shows important preliminary evidence of therapeutic activity for SPI-1005 in bipolar disorder. SPI-1005 treated patients had a 11.8-point reduction in Young Mania Rating Scale scores.
Lead Product(s): Ebselen
Therapeutic Area: Psychiatry/Psychology 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 04, 2020
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