Weekly Top News – Psoriasis – May 11, 2020

May 11, 2020

Otezla (apremilast) / Amgen
Amgen announces positive top-line results from Otezla (apremilast) phase 3 ADVANCE study in mild-to-moderate plaque psoriasis (BioSpace) – May 6, 2020 – P3, N=595; ADVANCE (NCT03721172); Sponsor: Amgen; “Amgen (NASDAQ:AMGN) today announced positive top-line results from the ADVANCE trial, a phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla (apremilast) in adults with mild-to-moderate plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a statistically significant improvement, compared with placebo, in the primary endpoint of the static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16….Detailed results will be submitted for presentation at an upcoming medical meeting.”


BMS-986165 / BMS
Bristol-Myers Squibb Co (BMY) Q1 2020 earnings call transcript (The Motley Fool) – May 7, 2020 – “Phase III trials both 046, 047 completed enrollment. So at this time, we are looking at follow-up of these patients, collection of the data and screening activity, so that we can approach the database lock. There is no reason to believe that there will be any delays. We’re looking toward — at the end of the year for readout of the first study 046 and first quarter of next year for 047 for the psoriasis program.”


EDP1815 / Evelo Biosci
Evelo Biosciences reports first quarter financial results and business highlights (GlobeNewswire) – May 11, 2020 – “Selected enteric capsule formulation of EDP1815 for Phase 2 dose ranging trial in psoriasis; trial initiation now expected in 3Q 2020, with interim data in mid-2021….This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks….Evelo also announced interim data from cohorts of individuals with either mild to moderate psoriasis…who were treated with the newer, alternate formulation of EDP1815 in the ongoing Phase 1b studies. Meaningful clinical responses were not observed in either cohort. Based on these data, Evelo is discontinuing development of the alternate formulation.”


IMU-935 / Immunic
Immunic, Inc. reports first quarter 2020 financial results and highlights recent activity (PRNewswire) – May 8, 2020 – “The current, single ascending dose part of the ongoing phase 1 trial of IMU-935, being conducted in Australia, is planned to be followed by a multiple ascending dose (MAD) portion in healthy volunteers and a safety evaluation in patients with mild-to-moderate psoriasis as a third part of this phase 1 trial. Based on the temporary pausing of trials in healthy volunteers imposed by Ethics Committees in Australia due to COVID-19, the MAD portion of the trial is expected to start in the second half of 2020.”

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