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Weekly Top News – IBD – August 12, 2019

August 12, 2019

Stelara (ustekinumab) / J&J
Ustekinumab Improved Work Productivity in Patients With Moderate to Severe Ulcerative Colitis: Results From the Phase 3 UNIFI Induction and Maintenance Studies (ACG 2019) – Aug 8, 2019 – Abstract #P1393; Pres time: Oct 28, 2019; 10:30 AM – 04:15 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline, patients had a mean percent work time missed ranging from 17.7% to 19.3%, impairment while working from 39.1% to 45.3%, overall work impairment from 43.7% to 49.1%, and activity impairment from 51.8% to 52.8%. At Wk8, patients who received UST IV had significantly greater improvement in WPAI domains and daily productivity VAS compared with PBO (Table). In the maintenance study, UST-treated patients generally maintained or numerically improved WPAI scores, while scores for patients in the PBO group worsened.”

 

Stelara (ustekinumab) / J&J
Effects of Ustekinumab Maintenance Therapy on Endoscopic Improvement and Histologic Improvement in the UNIFI Phase 3 Study in Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #56; Pres time: Oct 30, 2019; 08:40 AM – 08:50 AM; Location: Stars at Night Ballroom – B2; “At maintenance Week 44, EI was achieved in 28.6%, 43.6%, and 51.1% of pts treated with placebo, UST q12w (p=0.002 vs placebo), and UST q8w (p< 0.001), respectively. HI was achieved at Week 44 in 32.9%, 54.0%, and 59.3% of pts treated with placebo, UST q12w, and UST q8w, respectively (p< 0.001 for both q12w and q8w). MH was achieved at Week 44 in 24.1%, 38.8%, and 45.9% of pts treated with placebo, UST q12w (p=0.002), and UST q8w (p,0.001), respectively.”

 

Stelara (ustekinumab) / J&J
Molecular Response to Ustekinumab in Moderate-to-Severe Ulcerative Colitis by Serum Protein and Colon Transcriptomic Analysis: Results From the UNIFI Phase 3 Maintenance Study (ACG 2019) – Aug 8, 2019 – Abstract #P0454; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At Wk44 after the start of maintenance therapy, expression of colonic genes dysregulated in UC was altered towards normal levels in all treatment groups, with the greatest improvements among those receiving UST and those in clinical remission (p< 0.05 for Wk44 versus start of maintenance). No dose effect was observed between q8w and q12w UST doses, and no significant improvements in disease signature occurred in non-responders to placebo or UST. UST maintenance therapy magnified the normalization of serum proteins following UST induction; among pts receiving q8w UST who were in remission at Wk44, the proteins IFNγ, IL-17A, MMP3, and SAA reached concentrations comparable to those seen in healthy controls.”

 

Stelara (ustekinumab) / J&J
Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #P0505; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups.”

 

Entyvio SC (vedolizumab SC) / Takeda
Takeda submits New Drug Application for a subcutaneous formulation of vedolizumab for patients with moderately to severely active ulcerative colitis in Japan (Takeda Press Release) – Aug 8, 2019 – “Takeda…announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.”

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports second quarter 2019 financial results (PRNewswire) – Aug 7, 2019 – “Protagonist and Janssen are jointly conducting the development of PTG-200 through completion of a Phase 2 proof-of-concept study in Crohn’s disease. Protagonist and Janssen Biotech completed the filing of a U.S. Investigational New Drug (IND) application to support the global Phase 2 clinical study with initiation expected in the fourth quarter of 2019.”

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