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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

(HealthDay)

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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Plan Ahead to Keep Halloween Safe for Kids With Asthma, Allergies | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

TUESDAY, Oct. 6, 2020 (HealthDay News) — This Halloween may be especially challenging for parents of children with asthma and allergies, as they also have to guard against COVID-19.

“Every year we send out tips on how to keep your kids with allergies and asthma symptom-free as they celebrate one of their favorite holidays,” said allergist Dr. J. Allen Meadows, president of the American College of Allergy, Asthma and Immunology (ACAAI).

“This year, along with our usual guidance, we want to point people to the [U.S. Centers for Disease Control and Prevention] and their recommendations for avoiding COVID-19,” Meadows said in a college news release.

As you plan for the holiday, consider these tips from the ACAAI:

If kids are attending events, outdoor activities are always best. Children must wear a mask and maintain social distance. There are Halloween-themed cloth masks that help protect against COVID-19, so kids should be encouraged to choose a costume that works with a protective mask.

An ordinary costume mask is not a substitute for a mask meant to protect against the coronavirus. The CDC says a costume mask should not be worn over a cloth mask if the costume mask makes it hard to breathe.

Try to have Halloween activities around your home, where you can control the environment and the allergens. For example, you can make sure all treats are allergen-free if your child suffers from a food allergy.

Ideas for at-home fun include pumpkin carving, having a costume parade over Zoom, or a scavenger hunt in the house or yard with family members.

If your child does go trick-or-treating, the CDC recommends a one-way approach where individual goodie bags are lined up for families to grab at the end of a driveway or edge of a yard.

If you’re preparing goodie bags, make sure to wash your hands with soap and water for at least 20 seconds before and after preparing the bags. If your child goes trick-or-treating, check their bag for any candy that might contain food allergens.

If your child with allergies or asthma is attending a Halloween event or going one-way trick or treating, make sure they have their supplies with them.

Children with asthma should carry their inhaler because kicking up moldy leaves can cause asthma symptoms. If a child has a food allergy, they shouldn’t leave home without their epinephrine auto injector, in case they sneak a treat that contains a possible allergen.

Copyright © 2020 HealthDay. All rights reserved.

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