Immunology | Phase III Developments | UNITED STATES

Principia Biopharma

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

Principia Announces Positive Data from its Phase 2 Part B Trial in Pemphigus

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.

Gilead Sciences

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

New Analyses of Phase 2 EQUATOR Clinical Program Support Durable Efficacy of Filgotinib in Psoriatic Arthritis

Lead Product(s): Filgotinib

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 05, 2020

Details:

Phase 2 EQUATOR study and the EQUATOR-2 open-label extension study demonstrate filgotinib’s durable efficacy and consistent safety profile in people with active PsA, and showed rapid and sustained reductions in inflammatory biomarkers in patients with moderate to severe PsA.

Gilead Sciences

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis

Lead Product(s): Filgotinib

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 04, 2020

Details:

The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations.

Janssen Pharmaceutical

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

New First-in-Class Phase 3 TREMFYA® (guselkumab) Data Demonstrate Improvement in Psoriatic Arthritis Joint and Skin Symptoms at Week 52

Lead Product(s): Guselkumab

Therapeutic Area: Immunology Product Name: Undisclosed

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 June 03, 2020

Details:

Findings from the DISCOVER-1 and DISCOVER-2 studies presented at the 2020 European League Against Rheumatism E-Congress. These are the first one-year Phase 3 results evaluating p19 subunit-specific IL-23 inhibition in active psoriatic arthritis.

Eli Lilly

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

Lilly Shares New Data for Olumiant® in Rheumatoid Arthritis and Systemic Lupus Erythematosus

Lead Product(s): Baricitinib

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 03, 2020

Details:

Highlights from Olumiant data being presented at the virtual meeting include new long-term data in patients living with rheumatoid arthritis (RA) as well as data from an investigational trial in patients with systemic lupus erythematosus (SLE).

ChemoCentryx

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

ChemoCentryx Phase III ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis Presented at EULAR and ERA-EDTA Congresses

Lead Product(s): Avacopan,Rituximab,Cyclophosphamide

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 03, 2020

Details:

Pivotal trial demonstrated avacopan’s statistical superiority in sustaining remission at 52 weeks over the glucocorticoid-containing standard-of-care therapy.

Ocugen

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

Ocugen to Discontinue Phase 3 oGVHD Trial

Lead Product(s): Brimonidine Tartrate

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:

The decision to stop the trial is based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion.

AbbVie Inc

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthrit...

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.

Talaris Therapeutics

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

Update on Talaris’ Phase 2 Study of FCR001 in Living Donor Kidney Transplant Recipients to be Presented at ATC Virtual Congress

Lead Product(s): FCR001

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

Details:

Data reinforce potential of FCR001 to induce long-lasting immune tolerance to donated organ.

X4 Pharmaceuticals

Upgrade this company profile, update & customize all content// Ask PharmaCompass, click HERE

United States

Post An Enquiry

Virtual Booth

AFSSI Connexions 2020

Participation Not Confirmed

Update your events

X4 Pharmaceuticals Announces Data from Phase 2 Open-Label Extension Trial of Mavorixafor in WHIM Syndrome as Published in EHA Abstract

Lead Product(s): Mavorixafor

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 14, 2020

Details:

Data reveal reductions in annual infections and warts, and sustained dose-dependent increases in neutrophil counts.

Find

Find Immunology Drugs in Phase III Clinical Development in UNITED STATES

United States

Product Type

Companies

Principia Biopharma

Principia Announces Positive Data from its Phase 2 Part B Trial in Pemphigus

Gilead Sciences

New Analyses of Phase 2 EQUATOR Clinical Program Support Durable Efficacy of Filgotinib in Psoriatic Arthritis

Gilead Sciences

Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis

Janssen Pharmaceutical

New First-in-Class Phase 3 TREMFYA® (guselkumab) Data Demonstrate Improvement in Psoriatic Arthritis Joint and Skin Symptoms at Week 52

Eli Lilly

Lilly Shares New Data for Olumiant® in Rheumatoid Arthritis and Systemic Lupus Erythematosus

ChemoCentryx

ChemoCentryx Phase III ADVOCATE Trial of Avacopan in ANCA-Associated Vasculitis Presented at EULAR and ERA-EDTA Congresses

Ocugen

Ocugen to Discontinue Phase 3 oGVHD Trial

AbbVie Inc

AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthrit...

Talaris Therapeutics

Update on Talaris’ Phase 2 Study of FCR001 in Living Donor Kidney Transplant Recipients to be Presented at ATC Virtual Congress

X4 Pharmaceuticals

X4 Pharmaceuticals Announces Data from Phase 2 Open-Label Extension Trial of Mavorixafor in WHIM Syndrome as Published in EHA Abstract