Weekly Top News – IBD – May 18, 2020

brazikumab (AMG 139) / AstraZeneca
AstraZeneca recovery of global rights to brazikumab (MEDI2070) from Allergan completed (AstraZeneca Press Release) – May 11, 2020 – “AstraZeneca has completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. AstraZeneca and Allergan have terminated their previous license agreement and all rights to brazikumab have therefore now returned to AstraZeneca….Under the termination agreement, Allergan will fund up to an agreed amount, estimated to be the total costs expected to be incurred by AstraZeneca until completion of the development of brazikumab for Crohn’s disease (CD) and ulcerative colitis (UC), including the development of a companion diagnostic.”


brazikumab (AMG 139) / AstraZeneca
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrialsregister.eu) – May 12, 2020 – P3; N=1000; Sponsor: Allergan Limited


AK101 / Akesobio
Akeso gets approval for AK101 investigational New Drug Application in China (Reuters) – May 15, 2020 – “Announces approval for AK101 Investigational New Drug Application for ulcerative colitis in China”


PL8177 / Palatin Technologies
Palatin Technologies, Inc. reports third quarter fiscal year 2020 financial results and recent business highlights (PRNewswire) – May 12, 2020 – “A Phase 2 proof-of-concept clinical study with an oral formulation of PL8177 in ulcerative colitis patients is now targeted to start in the first half of calendar year 2021, with data readout in the first half of calendar year 2022.”


Stelara (ustekinumab) / J&J
SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (clinicaltrials.gov) – May 14, 2020 – P3b; N=386; Active, not recruiting; Sponsor: Janssen Scientific Affairs, LLC; Trial primary completion date: Apr 2020 –> Dec 2020


LC51-0255 / LG Chem
LG Chem Life Sciences Innovation Center announces data from phase I study of its ulcerative colitis treatment LC51-0255 (Businesswire) – May 14, 2020 – “P1,N=110; NCT03174613; Sponsor: LG Chem; Positive topline results of oral LC51-0255 presented at virtual Digestive Disease Week (DDW) 2020 as ePoster…was well-tolerated in healthy subjects using once-daily oral administration for up to 21 days….We are delighted to be moving LC51-0255 into Phase II this year.”


Stelara (ustekinumab) / J&J
PROUST: A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab (clinicaltrials.gov) – May 14, 2020 – P=N/A; N=221; Completed; Sponsor: Janssen Cilag S.A.S.; Active, not recruiting –> Completed


KB295 / Kaleido
Kaleido Biosciences provides corporate update and reports first quarter 2020 financial results (GlobeNewswire, Kaleido Biosciences) – May 14, 2020 – “Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021.”

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