Eli Lilly and Company (NYSE:LLY) announced that its interleukin-23 subunit p19 inhibitor mirikizumab achieved its primary endpoint of clinical remission at 52 weeks in the Phase 3 LUCENT-2 study. Lilly says mirikizumab is the first anti-IL23p19 to demonstrate maintenance of clinical remission in a Phase 3 ulcerative colitis study. Janssen (NYSE:JNJ) has ongoing clinical trials…
Rinvoq meets primary and important secondary endpoints in Phase 3 Crohn’s disease study
AbbVie (NYSE:ABBV) has released positive top-line results from U-EXCEED, which showed that Rinvoq (upadacitinib) hit both primary endpoints of clinical remission and endoscopic response at week 12 of a Phase 3 induction study focused on patients with Crohn’s disease. Upadacitinib is a selective and reversible JAK inhibitor first FDA approved in 2019 for treating adults with…
Janssen shares positive Phase 2 Tremfya data in Crohn’s
Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD). The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the…
Janssen shares new positive Stelara data for Crohn’s disease and ulcerative colitis
Janssen (NYSE:JNJ) has released new positive data for Stelara (ustekinumab) as first-line therapy in ulcerative colitis (UC) and treatment persistence in Crohn’s disease (CD). The data indicated that the monoclonal antibody Stelara was “the best choice” as a “first-line therapy in bio-naive patients with moderately to severely active ulcerative colitis and Crohn’s disease,” said Dr.…
Janssen presents new safety data for Stelara in older patients
Janssen’s Stelara (ustekinumab) was associated with a rate of safety events similar to that of placebo during the control phase of a range of clinical trials. The Johnson & Johnson (NYSE:JNJ) subsidiary shared the data related to adults 60 and older at the virtual United European Gastroenterology Week (UEGW). The study pooled safety data from…
Assembly Bio discontinues development of hepatitis drug ABI-H2158
Assembly Biosciences (NSDQ:ASMB) is halting the development of the hepatitis drug ABI-H2158 (2158) after observing elevated alanine aminotransferase (ALT) in participants in a Phase 2 trial. High ALT levels can indicate liver damage. “Patient safety is always our priority, which is why we have elected to discontinue the development of 2158,” said Dr. John McHutchison,…
Why Lamassu Pharma is developing a novel pancreatitis treatment
Acute pancreatitis, involving a sudden inflammation of the pancreas, is a major unmet need in gastroenterology. Severe cases can land patients in the ICU for weeks or months, while treatment options are relegated to support. The condition causes approximately 330,000 hospital admissions annually, according to a 2018 study. Some 20,000 people in the U.S. die from…
Scientists identify new strategy for treating inflammatory bowel diseases
Scientists at the Ben-Gurion University of the Negev (BGU) in Israel and Yonsei University in Seoul have identified a potential strategy to treat inflammatory bowel diseases (IBD). The method involves using peptides to reduce the effects of succinate, a proinflammatory molecule that gut bacteria release. The breakthrough could lead to a companion tool to diagnose and treat…
Stelara shows promise for long-term management of ulcerative colitis
Janssen’s (NYSE:JNJ) Stelara supported corticosteroid-free remission in about half of ulcerative colitis patients in a 152-week long-term extension UNIFI study. At the end of the nearly three-year study, 55.2% of volunteers were in symptomatic remission. Of those patients, 96.4% were corticosteroid-free at week 152. Janssen, which is part of Johnson & Johnson, presented the data…
New treatment tackles functional dyspepsia: Medical food
New treatments are emerging daily for countless conditions and diseases—pills and injectables being the foremost of these. But there is also another category of treatments that has been causing a stir in the healthcare market: medical food. According to the FDA, medical food is “intended for the specific dietary management of a disease or condition…