Weekly Top News – IBD – April 29, 2019

mirikizumab (LY3074828) / Eli Lilly

VIVID-1: A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Apr 24, 2019 – P3; N=1100; Not yet recruiting; Sponsor: Eli Lilly and Company
Clinical • New P3 trial

 

amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health

Salix enters into exclusive license agreement with Mitsubishi Tanabe Pharma to develop and commercialize late stage investigational S1P modulator for the treatment of inflammatory bowel disease (PRNewswire) – Apr 25, 2019 – “Salix Pharmaceuticals…announced today that its affiliate has entered into an exclusive licensing agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) (TSE: 4508) to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate (S1P) receptor that plays a role in autoimmune diseases, such as Inflammatory Bowel Disease (IBD) and ulcerative colitis.”
Licensing / partnership

 

Alofisel (darvadstrocel) / Takeda

Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”
Commercial • Pricing

 

Entyvio (vedolizumab) / Takeda

DEVELOPMENT AND VALIDATION OF A CLINICAL SCORING TOOL FOR PREDICTING TREATMENT OUTCOMES WITH VEDOLIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS (DDW 2019) – Apr 24, 2019 – Abstract #334; Pres time: May 19, 2019; 10:15 AM – 10:30 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Humira (adalimumab) / Eisai, AbbVie

Drug Induced Renal Granulomatous Disease – poor outcone of a rare clinical condition (NKF-CSM 2019) – Apr 23, 2019 – Abstract #166; “…We report such a case of granulomatous interstitial nephritis in a patient with Crohn’s disease after being treated with Adalimumab for 8 months…She was treated with prednisone 1 mg/kg/day, however renal function continued to decline and dialysis was initiated as inpatient…Renal recovery following such insults have been historically mixed, even with appropriate use of steroids. As such, TNF-α inhibitors should be used with caution with frequent monitoring of kidney function.”
Clinical

 

Entyvio (vedolizumab) / Takeda

VEDOLIZUMAB TARGETS LYMPHOID AGGREGATES IN THE GASTROINTESTINAL TRACT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE, REFLECTED BY A DRAMATIC DROP IN GUT-HOMING PLASMABLASTS IN CIRCULATION (DDW 2019) – Apr 24, 2019 – Abstract #335; Pres time: May 19, 2019; 10:30 AM – 10:45 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J

EARLY INFLIXIMAB PHARMACOKINETICS AND WEEK ONE CLINICAL RESPONSE IN PEDIATRIC ACUTE SEVERE ULCERATIVE COLITIS: THE ARCH STUDY (DDW 2019) – Apr 24, 2019 – Abstract #235; Pres time: May 19, 2019; 08:25 AM – 08:35 AM; Location: Room: 31BC – San Diego Convention Center; No abstract available.
Clinical • PK/PD data

 

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