Weekly Top News – Psoriasis – March 30, 2020

March 30, 2020
Psoriasis

ANB019 / AnaptysBioANB019: “Both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy”; Generalized pustular psoriasis (Cowen & Co. 40th Annual Health Care Conference 2020, AnaptysBio) - Mar 24, 2020 - “Patients demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113” [Screenshot]

Taltz (ixekizumab) / Eli LillyTaltz approved for pediatric patients with moderate to severe plaque psoriasis (eMPR) - Mar 27, 2020 - "The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy....The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (IXORA-Peds) that evaluated the efficacy and safety of ixekizumab in 171 patients aged 6 to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy."

AVT02 (adalimumab biosimilar) / Alvotech, CiplaAlvotech and DKSH partner on adalimumab in Asia (Generics Bulletin - Informa) - Mar 26, 2020 - "Alvotech has partnered with DKSH to bring its high-concentration Humira rival to Asia. The Alvogen sister company plans to file the adalimumab biosimilar with the EMA and FDA in the second half of 2020."

vunakizumab (SHR-1314) / Jiangsu Hengrui MedicineA Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults (clinicaltrials.gov) - Mar 23, 2020 - P2; N=120; Suspended; Sponsor: Jiangsu HengRui Medicine Co., Ltd.; Trial completion date: Jun 2021 --> Dec 2020; Not yet recruiting --> Suspended; Trial primary completion date: Mar 2021 --> Jun 2020

BMS-986165 / BMSEpidemic ‘secondary’ impact: Clinical trials and CDMO industry pressing the pause button [Google translation] (Sina Corp) - Mar 26, 2020 - "In the face of the epidemic, clinical trials can also respond in some ways, but the biggest risk may be that patients cannot follow up, and a large number of clinical trials are being threatened by the epidemic, and the delay has become a reality....At least five of these blockbusters were affected, including...Bristol-Myers Squibb's BMS-986165 (Tyk2)....On March 23, Galapago's founder and CEO Onno van de Stolpe also said that he would "suspend clinical trials of filgo to protect patient safety."

Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimIMMpact2: A Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (clinicaltrials.gov) - Mar 27, 2020 - P3; N=444; Active, not recruiting; Sponsor: AbbVie; Trial primary completion date: Jun 2020 --> Jan 2021