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Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
PEGASUS is a global, randomized, double-blind, placebo-controlled, pivotal, Phase 3 clinical trial enrolling approximately 120 participants to evaluate rilzabrutinib versus placebo, using a background treatment of tapering doses of corticosteroids (CS).
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Lead Product(s): SAR442168
Therapeutic Area: Immunology Product Name: SAR442168
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: $3,680.0 million Upfront Cash: $3,680
Deal Type: Acquisition August 17, 2020
Details:
The acquisition expands and accelerates development of Sanofi's BTK inhibitors consisting ‘168, rilzabrutinib and PRN473 Topical, across multiple indications.
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Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2020
Details:
The significance of this Phase 2 Part B trial is that rilzabrutinib, a reversible covalent oral BTK inhibitor, demonstrated a 40 percent complete remission (CR) rate after 24 weeks of treatment while the median corticosteroid (CS) dose was reduced to 6 mg.
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Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2020
Details:
Dr. Dedee Murrell from University of New South Wales will present data from Phase 2 Part B pemphigus trial drug rilzabrutinib, Principia’s leading Bruton’s tyrosine kinase inhibitor.
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Lead Product(s): Risankizumab
Therapeutic Area: Immunology Product Name: Skyrizi
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2021
Details:
In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved the primary endpoint of ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo.
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Lead Product(s): Upadacitinib
Therapeutic Area: Immunology Product Name: Rinvoq
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
Across pivotal clinical trial programs, RINVOQ (15 mg, once daily) demonstrated efficacy across multiple measures of disease activity in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a safety profile consistent with that seen in rheumatoid arthritis.
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Lead Product(s): Upadacitinib
Therapeutic Area: Immunology Product Name: Rinvoq
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
Details:
The applications to the FDA and EMA are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which RINVOQ demonstrated significant improvements in signs and symptoms in patients with active ankylosing spondylitis.
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Lead Product(s): Upadacitinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
Submissions supported by two Phase 3 studies in which RINVOQ demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo.
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Lead Product(s): Sparsentan
Therapeutic Area: Immunology Product Name: RE-021
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 13, 2021
Details:
Sparsentan is an investigational product candidate currently being evaluated for the treatment of IgAN, as well as focal segmental glomerulosclerosis in pivotal Phase 3 clinical trials that are expected to report topline data from interim proteinuria assessments in 2021.
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