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The combined company will advance innovative pipeline of Natural Killer T modulating therapies for the treatment of inflammatory, fibrotic and autoimmune diseases, including GRI-0621, an inhibitor of type 1 NKT cells.
Lead Product(s): GRI-0621
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: GRI-0621
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: GRI Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger April 21, 2023
Details:
GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human NKT I cells. In in vitro studies and after 28 days dosing in the study GRI-0621-201, oral dosing of GRI-0621 has been shown to inhibit NKT I cells in patients.
Lead Product(s): GRI-0621
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: GRI-0621
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: GRI Bio
Deal Size: $25.0 million Upfront Cash: $15.0 million
Deal Type: Merger December 13, 2022
Details:
Pharmacokinetic analysis showed that ADAIR (dextroamphetamine) intranasally demonstrated blunted pharmacokinetic profile compared to crushed and snorted dextroamphetamine including Cmax,Tmax, and AUC, especially during early time points up to 1, 2, and 4 hours after dosing.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
ADAIR (dextroamphetamine), investigational new drug; a novel, patented formulation designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high".
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
Study did not meet primary endpoint of significant reduction in Emax Drug Liking for ADAIR (dextroamphetamine) vs reference dextroamphetamine, although a trend in favor of ADAIR was observed (p=0.16).
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2021
Details:
Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.
Lead Product(s): Amphetamine
Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
Company to begin enrolling phase 1 clinical trial for first immune tolerance product, KAN-101, in first quarter of 2020.
Lead Product(s): Amphetamine
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2020
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