Gossamer Bio Announces Topline Results for Phase 2 Trials of Oral GB001 in Asthma and Chronic Rhinosinusitis

– Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups –

– Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group –

– TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints –

– Gossamer to hold webcast to discuss trial results at 8:00 am EDT –

Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

“While we did not achieve statistical significance on the primary endpoint in the LEDA Study, we are encouraged by the consistent results observed for all three doses of once-daily, oral GB001 therapy across the primary and secondary endpoints,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. “We believe these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program.”

“The results of the robust LEDA Study are meaningful and help us to further understand the DP2 pathway in asthma,” said Bruce Levy, M.D., Chief, Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School. “I believe GB001 as an oral treatment has the potential to serve the high unmet need of patients with uncontrolled severe asthma.”

LEDA Phase 2b Trial Design

The LEDA trial enrolled 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma and assessed the effect of oral GB001 add-on therapy to standard of care over 24 weeks, comparing three dose groups of once-daily, oral GB001 (20 mg, n=120; 40 mg, n=118; and 60 mg, n=122) to placebo (n=120).

The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. A patient was considered to have experienced asthma worsening if they met any of the five components by Week 24. This endpoint has previously been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.

LEDA Primary and Secondary Endpoint Results

The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for the GB001 20 mg, 40 mg, and 60 mg groups, respectively. In addition, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo

Study Probes Links in Asthma, Food Sensitivity and Irritable Bowel Syndrome | Health News

By Robert Preidt, HealthDay Reporter


MONDAY, Oct. 12, 2020 (HealthDay News) — Teens who had asthma and food hypersensitivity when they were younger are at increased risk of irritable bowel syndrome (IBS), researchers report.

For the study, the investigators examined the health of 2,770 children from birth to age 16. Kids with IBS at age 16 were more likely to have had asthma at age 12 (about 11% versus 7%).

In addition, the researchers found that 16-year-olds with IBS were more likely to have had food hypersensitivity at age 12 (41% versus 29%).

Asthma, food hypersensitivity and eczema (a condition that makes your skin red and itchy) were all associated with an increased risk of concurrent IBS at age 16, the findings showed.

“The associations found in this large study suggest there’s a shared pathophysiology between common allergy-related diseases and adolescent irritable bowel syndrome,” said study leader Jessica Sjölund, of the Institute of Medicine at the University of Gothenburg, in Sweden.

Sjölund noted that previous studies on allergy-related diseases and IBS have been contradictory.

These new findings could lead to development of new treatments for adolescent IBS, targeting processes of low-grade inflammation seen in the allergy-related diseases, she said.

The study findings were scheduled for presentation Monday at a United European Gastroenterology virtual meeting. Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.

IBS affects more than one in 10 people and is the most common functional gastrointestinal disorder, the study authors noted in a meeting news release. It can cause abdominal cramps, bloating, diarrhea and constipation, and can be extremely disabling for patients.

Hans Törnblom is a leading IBS expert in Europe who was involved in the research. He said, “Even though functional gastrointestinal disorders are common, many patients are, unfortunately, negatively stigmatized and labeled. The fact that many IBS sufferers do not seek medical advice should be of great concern.”

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more on IBS.

Copyright © 2020 HealthDay. All rights reserved.

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Common Allergy and Asthma Medication Can Cause Suicidal Thoughts in Children, FDA Says

Rick Friedman/Corbis via Getty

An FDA announcement regarding a new warning for a common allergy and asthma medication with serious mental health side effects went under the radar earlier this year due to the global coronavirus crisis.

On March 4th, just before the COVID-19 outbreak was declared a pandemic, the FDA said they would start requiring a boxed warning — their most serious — for the drug montelukast, which is also marketed under the brand name Singulair.

“We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the FDA wrote. “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed.”

The prescription medicine, which was first approved by the FDA in 1998, is used to prevent asthma attacks in adults and children as well as to help control symptoms of asthma and allergic rhinitis, also known as hay fever.

Other mood-related side effects may include aggressive behavior, anxiousness, depression, memory loss, disorientation, disturbance in attention, insomnia and dream abnormalities, stuttering, hallucinations, obsessive compulsive symptoms, suicidal thinking and suicide.

RELATED: WHO Suspends Hydroxychloroquine Trials After Reports of High Death Rates in COVID-19 Patients

The FDA has determined that the prescription “should not be the first choice treatment” particularly for patients with mild symptoms, noting that “many other safe and effective allergy medicines are widely available.”

Healthcare providers are being advised to alert all patients receiving the prescription about the potential serious side effects. Patients should also be told to immediately stop use of the drug and seek professional help if any adverse mental health symptoms occur.

The FDA went on to note that although most “neuropsychiatric events” occurred while patients were still using the drug, some have reported persisting symptoms after stopping montelukast treatment.

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For more than a decade, concerns have been raised about the drug.

A 15-year-old boy in the United States committed suicide in 2008, about a month after he began taking Singular, according to WNYT-TV. Although at the time, his mother said she did not make a connection between her son’s death and the medication, that began to change after a relative found reports of similar cases.

“Children are dying. They’re dying and they’re mentally being tortured for years before people figure out that this is their asthma drug,” she told the outlet last year, while speaking about her work trying to get the FDA to issue a boxed warning.

In Australia, concerned parents have also spoken out against the drug, including Mary Hozen, whose daughter Sarah had been taking

Asthma and Allergy Foundation of America (AAFA) and IMPACT DC Partner on Bridging Health Disparities Gap

AAFA, IMPACT DC team up with a focus on expanding nationwide community health programming

Image courtesy IMPACT DC
Image courtesy IMPACT DC
Image courtesy IMPACT DC

Washington D.C., Oct. 08, 2020 (GLOBE NEWSWIRE) — In the United States, the burden of asthma falls disproportionately on poor, low-wealth, and minority populations. Decades of research and public health data show stark disparities in asthma prevalence, mortality and health care utilization along socioeconomic, racial, and ethnic lines with Black, Hispanic and Indigenous Americans under the heaviest burden. This was once again demonstrated in the comprehensive report Asthma Disparities in America: A Roadmap to Reducing Burden on Racial and Ethnic Minorities issued by the Asthma and Allergy Foundation of America (AAFA).

The problem can’t be solved alone. That’s why AAFA and the Improving Pediatric Asthma Care in the District of Columbia (IMPACT DC) Asthma Clinic at Children’s National Hospital are coming together to lead a national collaborative dedicated to reducing asthma disparities by strengthening self-sustaining, community-based asthma management. The goal is to implement a new, national model that will reduce emergency room visits, cut death rates, lower school and work absences, bring down health care spending, and improve quality of life within the next ten years.

“Community programs have proven to be an effective intervention tool for improving health outcomes in local communities,” said Kenneth Mendez, president and CEO of AAFA. “Unfortunately, systemic barriers get in the way of the growth of these programs on a national scale. Our partnership with IMPACT DC helps advance our mission of prioritizing policies and programs to improve asthma health for Americans most at risk while dismantling systems that fuel harmful disparities. Making a real and lasting difference is an achievable goal when groups and individuals with a shared, critical interest come together. Partnering to find sustainable solutions will help lead to a vast reduction in asthma disparities and help promote health parity overall. When we narrow gaps in asthma care and outcomes for underserved groups of people, we truly advance care and management for everyone with asthma.”

“Despite novel treatments and guideline-based care, asthma remains a significant public health problem, disproportionately affecting minorities and socioeconomically disadvantaged children. Asthma health disparities are often due to the effects of poverty and substandard housing, with environmental triggers as a major contributor. At IMPACT DC, we partner with local housing organizations and the government to improve poor indoor air quality due to mold and other hazards,” said Dr. Shilpa Patel, medical director at IMPACT DC and attending physician in the division of emergency medicine at Children’s National Hospital. “Coordinating world-class care at Children’s National Hospital, with our incredible community partners, has allowed us to improve the lives of the most at-risk children with asthma.  We hope to leverage AAFA’s national platform to bring together programs in other cities so that we can learn from each other and create a best-practice model to address pediatric asthma health disparities at the national level.”

AAFA and IMPACT DC will bring leading experts together to share best