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Details:
Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Botanix Pharma
Deal Size: $8.2 million Upfront Cash: $8.2 million
Deal Type: Agreement July 21, 2023
Details:
FRTX-02 is a potential dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor that aims to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases.
Lead Product(s): FRTX-02
Therapeutic Area: Dermatology Product Name: FRTX-02
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 07, 2023
Details:
FRTX-02 is a highly selective, and orally bioavailable potential first-in-class dual specificity tyrosine-phosphorylation-regulated kinase 1A inhibitor that is currently being evaluated in Phase 1 clinical trial for atopic dermatitis and rheumatoid arthritis.
Lead Product(s): FRTX-02
Therapeutic Area: Dermatology Product Name: FRTX-02
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 11, 2023
Details:
FRTX-02 is potent, highly selective, and orally bioavailable potential first-in-class DYRK1A inhibitor that aims to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases.
Lead Product(s): FRTX-02
Therapeutic Area: Dermatology Product Name: FRTX-02
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 September 13, 2022
Details:
BBI-02 is a highly selective and orally bioavailable DYRK1A (dual specificity tyrosine-phosphorylation-regulated kinase 1A) inhibitor that has demonstrated promising results in various preclinical models, including atopic dermatitis and rheumatoid arthritis.
Lead Product(s): BBI-02
Therapeutic Area: Dermatology Product Name: BBI-02
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 19, 2022
Details:
The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
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 October 07, 2021
Details:
Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
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 April 27, 2021
Details:
The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
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 April 23, 2021
Details:
First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Ecclock
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 December 07, 2020
Details:
The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
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 October 06, 2020
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