Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.

In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.

After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.  

Mirikizumab efficacy in LUCENT-3


Read more
  • 0

Janssen’s pathway strategy for immune-mediated inflammatory disease shows promise in gastroenterology

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease.

Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet need for patients living with immune-mediated diseases,” said Dr. Jan Wehkamp, Janssen’s vice president, gastroenterology disease area leader.

And thus, a drug like Janssen’s Tremfya (guselkumab), which is now indicated to treat moderate-to-severe plaque psoriasis and psoriatic arthritis in adults, could find use in gastroenterological conditions such as Crohn’s disease (CD) or ulcerative colitis (UC).

Tremfya selectively blocks the p19 subunit of interleukin (IL)-23.

Read more

  • 0

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. Jan Wehkamp, vice president, gastroenterology disease area leader, Janssen Research & Development, in an interview.

In a separate analysis, Stelara led to more persistent therapeutic effects than Humira (adalimumab) at 12 months in bio-naive CD patients. Janssen gathered the CD data from de-identified health insurance claims.

Janssen presented the data, based on new modeling and real-world evidence analyses, at the American College of Gastroenterology Annual Scientific Meeting (ACG).

First-line Stelara patients with moderately to severely active UC tended to have a…

Read more
  • 0

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 13 clinical trials across approved indications, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The analysis included data for up to five years.

“This particular analysis builds on the complete data we have on the safety of Stelara over thousands of patients and literally dozens of clinical trials over 20 years now,” said Dr. Andrew Greenspan, vice president of medical affairs at Janssen Immunology.

The analysis is also noteworthy in its focus on patients 60 and older, Greenspan said.

“Often, we limit patients who are older from the clinical trials, and that’s not …

Read more
  • 0

Theravance cuts 75% of staff after ampreloxetine failure

Theravance Biopharma (NSDQ:TBPH) has announced today that it is laying off 75%, or roughly 270, of its employees.

The South San Francisco, California–based company employed 359 people in 2020, according to its most recent annual report.

The company plans on making the bulk of the cuts in November, with more to follow in early 2022.

Theravance also revealed that a Phase 3 study of the orepinephrine reuptake inhibitor ampreloxetine did not meet its primary endpoint of improving treating neurogenic orthostatic hypotension (OH). Specifically, the trial focused on a symptom assessment based on the Orthostatic Hypotension Questionnaire, which evaluates symptoms such as dizziness, weakness, fatigue and difficulty concentrating.

“These are not the results we had hoped to achieve, especially given the clear unmet need for patients suffering from symptomatic nOH and the positive top-line four-week results from the Phase 2 study announced in 2018. We will co…

Read more
  • 0

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 inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.

The gut levels of succinate are considerably higher in macrophages of IBD patients, according to BGU professor Ehud Ohana. Furthermore, IBD patients have altered succinate-metabolizing bacteria that likely results in inflammation-inducing succinate surges. The international research team reported slowing succinate absorption by deploying peptide sequences that mimic the binding site within succinate binding enzymes.

The researchers developed a method of targeting and chelating surplus succinate in IBD patients. To do …

Read more
  • 0

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 today at the Congress of the European Crohn’s and Colitis Organisation (ECCO).

Stelara (ustekinumab) enabled more than half of the patients in the trial to achieve remission without the need for steroids. That fact is one of the most critical findings in the recent data, said Dr. Jan Wehkamp, VP and gastroenterology disease area leader at Janssen.

While the human body naturally produces steroids, long-term use of corticosteroids leads to significant side effects in most people. They can lead to everything from high blood pressure, elevated blood sugar, glaucoma and other prob…

Read more
  • 0