Weekly Top News – Psoriasis – June 17, 2019

June 17, 2019

benvitimod (GSK2894512) / Roivant
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002) (clinicaltrials.gov) – Jun 12, 2019 – P3; N=500; Recruiting; Sponsor: Dermavant Sciences GmbH


Taltz (ixekizumab) / Eli Lilly
Lilly to present 5-year sustained efficacy and safety results for Taltz (ixekizumab) in patients with plaque psoriasis at the World Congress of Dermatology (Eli Lilly Press Release) – Jun 11, 2019 – “Eli Lilly and Company…announced today the company will present positive, five-year Phase 3 data for Taltz® (ixekizumab). Patients with moderate- to severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes…will be presented at the World Congress of Dermatology (WCD) in Milan, Italy on June 11….Four-year data from UNCOVER-3 will also be presented at the WCD….Later this year, Lilly plans to announce the results from IXORA-R, a clinical trial designed to evaluate superiority between Taltz and Tremfya® (guselkumab) in adult patients with moderate- to severe plaque psoriasis.”


Cosentyx (secukinumab) / Novartis
FUTURE 2: Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis (clinicaltrials.gov) – Jun 12, 2019 – P3; N=399; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial primary completion date: May 2014 –> Jan 2019


Tremfya (guselkumab) / J&J
Janssen reports top-line phase 3 results for Tremfya (guselkumab) in adults with active psoriatic arthritis(Businesswire) – Jun 14, 2019 – P3, N=383, DISCOVER-1 (NCT03162796); P3, N=741; DISCOVER-2 (NCT03158285); Sponsor: Janssen Research & Development; “The Janssen Pharmaceutical…today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies…in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent…Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.”


Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) vs. Humira (adalimumab) in a head-to-head (SPIRIT-H2H) superiority study in patients with active psoriatic arthritis at the European Congress of Rheumatology (Eli Lilly Press Release) – Jun 14, 2019 – P4, N=566; SPIRIT-H2H (NCT03151551); Sponsor: Eli Lilly and Company; Eli Lilly and Company…announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15….The primary endpoint of the study was superiority for Taltz compared to Humira…achieved a reduction by at least 50 percent in disease activity as defined by the American College of Rheumatology (ACR50) and complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI 100)….No new safety signals were detected.”


Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
New two-year data at the 24th World Congress of Dermatology shows Skyrizi (risankizumab) maintains complete skin clearance (AbbVie Press Release) – Jun 11, 2019 – P3, N=507; IMMHance (NCT02672852); Sponsor: Abbvie; “AbbVie…today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94….These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan….No new safety findings observed at two years (104 weeks)…”


Cosentyx (secukinumab) / Novartis
Novartis Cosentyx first to show efficacy in all key manifestations of psoriatic arthritis (GlobeNewswire) – Jun 12, 2019 – P3b, N=502; MAXIMISE(NCT02721966); Sponsor: Novartis Pharmaceuticals; “Novartis…announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials…These data…will be presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.”


pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – Jun 10, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.


Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces late-breaking phase 2 data showing potential of Ilumya (tildrakizumab-asmn) to improve joint and skin symptoms of psoriatic arthritis (PRNewswire) – Jun 14, 2019 – “Sun Pharmaceutical…today announced interim results from a Phase 2 study of…ILUMYA (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (abstract #LB-0002). The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study….We are now exploring a possible Phase 3 trial for psoriatic arthritis with regulatory authorities.”


Cosentyx (secukinumab) / Novartis
Cosentyx provides long lasting inhibition of radiographic progression in psoriatic arthritis, new Novartis data show (GlobeNewswire) – Jun 12, 2019 – P3, N=998; FUTURE 5 (NCT02404350); Sponsor: Novartis Pharmaceuticals; “Novartis…announced today new data from the FUTURE 5 trial showing no radiographic progression (mTSS)

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