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Beyond Celiac Chosen by 9 Meters Biopharma as Exclusive Patient Organization to Recruit for First-Ever Phase 3 Clinical Trial

Premier Patient Recruiter for Celiac Disease Research, Beyond Celiac Taps Extensive Network to Advance Study

Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3
Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 3

Philadelphia, PA, Oct. 14, 2020 (GLOBE NEWSWIRE) — Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has been chosen by 9 Meters Biopharma, Inc. (Nasdaq: NMTR) as the exclusive patient organization to recruit for the first-ever Phase 3-stage clinical trial therapeutic for treatment of celiac disease. Beyond Celiac will use its unrivaled connection to the celiac disease community and its powerful online patient database to recruit participants for the study of larazotide acetate, which aims to address leaky gut in celiac disease.

“We really listen to our community’s wants and needs. Because of our extensive connection to the people and commitment to connecting researchers with our community, Beyond Celiac has become the partner of choice for leading biotechnology and pharmaceutical companies such as 9 Meters,” said Beyond Celiac CEO Alice Bast. “This is the furthest a celiac disease clinical trial has gone, and it’s an exciting opportunity for our organization to play a vital role in fulfilling its promise.”

9 Meters Biopharma is evaluating larazotide acetate for celiac disease patients who continue to experience gastrointestinal symptoms while following a gluten-free diet. Designed to tighten junctions between intestinal cells, larazotide acetate would act like shoelaces to help restore leaky junctions to a normal state and would be used in addition to the gluten-free diet. It is being tested at more than 100 clinical sites, with a goal of 525 study participants. Results are expected by the end of 2021.

By partnering with Beyond Celiac for recruitment, 9 Meters Biopharma now has access to the power of Go Beyond Celiac, a secure online patient database with thousands of users who share their celiac disease stories and experiences with researchers and seek to become involved in studies.

“Our conservative estimate is that our celiac disease program is at least two years ahead of everyone else’s,” said John Temperato, president and CEO of 9 Meters Biopharma. “Beyond Celiac is going to help us across the finish line in developing the effective treatments that celiac patients deserve.”

Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer.

 

About Beyond Celiac

Founded in 2003,

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

Michigan Medicine begins recruitment for phase 3 of Janssen COVID-19 vaccine trial

ANN ARBOR, Mich. (WXYZ) — The University of Michigan announced Monday that Michigan Medicine has begun recruiting for phase 3 of the Janssen COVID-19 clinical trial.

The trial, known as the ENSEMBLE study, will evaluate a vaccine for the prevention of COVID-19 as part of a double-blind phase 3 clinical trial.

U-M is one of several sites across the world supporting the trial, which hopes to enroll up to 60,000 people worldwide.

“Michigan Medicine is committed to supporting the continued study of the investigational Janssen vaccine and other vaccine candidates. These trials are crucial to moving us toward an effective vaccine,” says Marschall Runge, M.D., Ph.D., Dean, U-M Medical School, Executive Vice President, Medical Affairs and CEO, Michigan Medicine.

This is the second trial being done on COVID-19 vaccines at U-M. They are also doing an AstraZeneca trial.

Enrollment is open for both trials now, and you can apply to be part of it by visiting uofmhealth.org/covid19-vaccine

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Michigan Medicine, Janssen now recruiting for phase 3 COVID-19 vaccine trial

ANN ARBOR – Michigan Medicine and Janssen, a division of Johnson & Johnson, are now recruiting for a double-blind phase III COVID-19 vaccine clinical trial.

Known as the ENSEMBLE study, the trial will test an investigational vaccine to prevent COVID-19.

The University of Michigan is one of several test sites around the globe supporting the trial, which aims to enroll up to 60,000 volunteers. Researchers hope to enlist a diverse group of participants in the latest trial as part of Operation Warp Speed, a U.S. Department of Health and Human Services public/private partnership.

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“Michigan Medicine is committed to supporting the continued study of the investigational Janssen vaccine and other vaccine candidates. These trials are crucial to moving us toward an effective vaccine,” Marschall Runge, M.D., Ph.D., Dean, U-M Medical School, Executive Vice President, Medical Affairs and CEO, Michigan Medicine said in a statement.

The Janssen study is the second COVID-19 trial to be recruiting at U-M, along with the AstraZeneca trial. Once enrollment opens for the trials, interested participants who meet qualifying criteria will be considered.

For more information about the study, visit https://www.uofmhealth.org/covid19-vaccine or email [email protected]

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Kuur Therapeutics Announces Publication of Interim Phase 1 Data for CAR-NKT Cell Therapy KUR-501 in Nature Medicine

Kuur Therapeutics, a leader in the development of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies, today announced the publication in Nature Medicine of interim findings from its ongoing phase 1 GINAKIT2 clinical trial collaboration with Baylor College of Medicine and Texas Children’s Hospital, in high risk relapsed refractory (R/R) patients with neuroblastoma, a form of childhood cancer.

The interim results demonstrated that expressing the CAR with interlukin-15 (IL-15), a natural protein that supports NKT survival, enhanced the tumor-fighting capabilities and in vivo persistence of autologous NKT cells. Two of three patients studied showed tumor reduction following CAR-NKT infusion: one classified as stable disease and the other as a partial response. Imaging revealed a dramatic reduction in the size and metabolic activity of bone metastases in the patient with the partial response. CAR-NKT cells demonstrated a favorable safety profile and localized to the site of the neuroblastoma tumors.

Kuur is the first company to test CAR-NKT cell therapy in patients. The company’s revolutionary platform engineers CARs on invariant NKT cells, a subset of T lymphocytes. NKT cells represent the next generation of CAR therapy, because this innovative approach harnesses the innate tumor-homing properties of NKT cells, a specialized type of lymphocyte that eliminates tumor-supportive macrophages, activates anti-tumor NK, dendritic and CD8 T cells, and does not induce graft versus host disease when used in an allogeneic setting.

“These results validate the biology of CAR-NKT cells in that they home to tumor and marrow, expand and have tumor killing properties. They also demonstrate safety and enhanced tumor homing capabilities, offering distinct advantages over other cell types for the treatment of solid and hematological tumors,” said Kurt C. Gunter, MD, CMO of Kuur. “Using our novel engineering platform, we have manufactured CAR-NKT cells with high purity and added IL-15 to the CAR construct, which further increases in vivo persistence and anti-tumor activity. We look forward to continuing our research with the experts in cellular and gene therapy at Baylor as we aim to leverage the CAR-NKT cell approach to create more precise and effective therapies for cancer patients, including allogeneic therapies.”

The results published were derived from the three heavily pre-treated, R/R metastatic neuroblastoma patients in dose level 1 (3×106 CAR-NKTs/m2) of the GINAKIT2 clinical study. These data were originally presented at the 23rd Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in May 2020. The trial is currently enrolling at the fourth and highest dose level.

About KUR-501

KUR-501 is an autologous product in which natural killer T (NKT) cells are engineered with a chimeric antigen receptor (CAR) targeting GD2, which is expressed on almost all neuroblastoma tumors. KUR-501 is also designed to address key limitations of current CAR immune cell therapies by secreting the cytokine IL-15, which has been shown in nonclinical studies to increase the persistence of CAR-NKT cells and improve their efficacy within the immunosuppressive tumor microenvironment. KUR-501 is being tested in the phase 1

Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis

— Filgotinib 200mg Achieved Endoscopic, Histologic and Six-Month Corticosteroid-Free Remission at Week 58 with a Consistent Safety Profile —

— Study Enrolled Biologic-Naïve and Biologic-Experienced Patients, a High Proportion of Whom Were Highly Refractory —

Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis (UC). The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58. In addition, significantly more patients achieved six-month corticosteroid-free remission. The full results were presented today at the 2020 United European Gastroenterology Week (UEGW) Virtual Meeting (Abstracts #LB19 and #LB20).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005470/en/

UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum. An increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2 million people around the world. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep and fatigue.

“There remains a tremendous need for treatments that can achieve meaningful and sustained clinical outcomes in ulcerative colitis,” said Laurent Peyrin-Biroulet, MD, PhD, Gastroenterology Department at Lorraine University in France, and presenting investigator of the SELECTION maintenance study. “These study results showed that filgotinib reduced bleeding and stool frequency while also achieving remission across a range of measures, including endoscopy and histology, in an oral formulation.”

The SELECTION study included biologic-naïve patients, for whom prior conventional therapy had failed, as well as biologic-experienced patients – a high proportion of whom had been non-responders to at least two different lines of prior biologics. In total, 43 percent of patients in the biologic-experienced cohort had failed treatment with both a TNF inhibitor and vedolizumab. The study allowed the enrollment of patients who were taking steroids, and/or immunomodulators, including methotrexate, mercaptopurine (6-MP) or azathioprine, as they would in real-world clinical practice.

Efficacy Data of Filgotinib in Induction and Maintenance

Overall, 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active UC were randomized and treated in the SELECTION study. Among biologic-naïve patients treated with filgotinib 200 mg, a significantly higher proportion of patients achieved clinical remission at Week 10 compared with placebo (26.1% vs. 15.3%, p=0.0157). Additionally, a significantly higher proportion of biologic-naïve patients treated with filgotinib 200 mg versus placebo achieved Mayo Clinic Score (MCS) remission (24.5% vs. 12.4%, p=0.0053), endoscopic remission (12.2% vs. 3.6%, p=0.0047) and histologic remission (35.1% vs. 16.1%, p<0.0001). A significantly higher proportion of biologic-experienced patients treated with filgotinib 200mg achieved clinical remission at Week 10 compared with placebo (11.5% vs. 4.2%, p=0.0103).

Patients treated with filgotinib who achieved clinical response or

South Korea’s Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

By Sangmi Cha

SEOUL (Reuters) – South Korean drugmaker Celltrion Inc <068270.KS> said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion’s senior executive vice president, told Reuters.

Celltrion began commercial production of the drug in September – likely to amount to around 1 million doses – in anticipation of demand in both domestic and overseas markets.

In July, Celltrion separately launched overseas human trials of its treatment in Britain.

(Reporting by Sangmi Cha; Editing by Kenneth Maxwell)

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Online fitness stars bank on virtual gyms being more than just a phase

Melas’ move into the world of hybrid in-person and digital fitness is an example of a broader trend, which sees Australians now saying will continue virtual workouts having tried them throughout the pandemic.

New research from fitness class scheduling and booking app Mindbody has found that, while most prefer in-person fitness classes over opening their laptops to get the endorphins flowing, over half (51 per cent) anticipate continuing virtual workouts once a week, and 37 per cent expect to keep working out virtually two to three times weekly.

New features

Earlier this year, Mindbody itself added on-demand and livestream features for use by the 5000 Australian gyms, yoga and dance studios, and other fitness operators that use its software.

Its study found that yoga (32 per cent) was the most popular class to do from home, while pilates (28 per cent) and strength training (26 per cent) had been the classes most Australians had returned to in-person during the July period when restrictions eased in most of Australia.

Mindbody’s 2020 New Normal survey was taken by 702 people across Australia about their pre-COVID-19 and current fitness habits. It was conducted between August 11 and August 20, with respondents aged from 18 to 65.

Mindbody Asia-Pacific vice president and managing director Hema Prakash says more Australians will now expect both the studio and virtual fitness experience to be available post-COVID.

“We’re saying to everyone this hybrid model is not a new normal, it’s going to be your absolute normal,” she says.

Mindbody’s customers – gym owners and fitness operators – are on average reporting revenues down around 25 per cent on the previous year due to COVID-19.

Prakash says the businesses faring best were doing so because of extensive customer surveys and having already built up a strong sense of community.

Sydney-based Pilates instructor Bianca Melas has attracted a loyal base of clients to her online platform. 

“If you are a business person that accidentally came into this world of wellness, and you’ve relied on luck, you may not survive this next six months. If you didn’t build the community aspect of your brand and business, it’s going to be super hard to start from scratch again right now,” Ms Prakash said.

In April, around 800 of Mindbody’s then 3000-strong global workforce were laid off or furloughed. The company has since re-hired some as pre-COVID fitness spending levels have rebounded.

In fact, the Mindbody New Normal survey found that the majority of respondents planned to spend the same amount or more on fitness compared to pre-COVID.

In NSW, 87 per cent of respondents felt this way, in Victoria, that figure was 75 per cent, in Queensland, that figure was 89 per cent, and in Western Australian, that figure was 80 per cent.

Melas says her shift to hosting virtual classes had required her to pay attention to details, like virtual room aesthetics and compiling accompanying Spotify music playlists. She says the snappy 30-minute classes have resonated well with clients.

She launched

First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine

The Alliance’s anti-COVID-19 Hyperimmune Globulin (CoVIg-19) medicine is under evaluation as part of the trial and may become one of the earliest treatments for hospitalized individuals at risk for serious complications of COVID-19

The CoVIg-19 Plasma Alliance urges anyone who has recovered from COVID-19 to consider donating plasma. To learn more, please visit TheFightIsInUs.org. 

OSAKA, Japan and KING OF PRUSSIA, Pa., Oct. 8, 2020 /PRNewswire/ — The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, today confirmed that patients are now being enrolled in the Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) Phase 3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial will evaluate the safety, tolerability and efficacy of an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine for treating hospitalized adults at risk for serious complications of COVID-19 disease. If successful, the Alliance’s H-Ig may become one of the earliest treatment options for hospitalized COVID-19 patients.

The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.
The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.

This global multi-center, double-blind, placebo-controlled, randomized trial will enroll 500 adult patients at up to 58 sites in the United States, Mexico and 16 other countries on five continents  (utilizing the NIH’s global INSIGHT Network), who have been hospitalized for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure. Patients will receive remdesivir as standard of care, allowing the safety and efficacy of H-Ig to be evaluated when given along with remdesivir treatment. The investigational H-Ig materials for the trial will be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as by two other companies. 

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance. “This study will help us understand how CoVIg-19 could potentially become an important therapeutic option. To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”

“When we created the CoVIg-19 Plasma Alliance in April, the goal was to partner to accelerate our timelines so that we could develop and deliver a reliable and sustainable treatment option for people suffering the impact of COVID-19 and to support countries around the world in their efforts to fight the current pandemic,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of

Lamont Considers Phase 3 Opt-Out For Coronavirus Outbreak Towns

CONNECTICUT — Gov. Ned Lamont is now considering giving towns with a high volume of coronavirus cases discretion to stay at the second reopening phase.

“I think we are thinking about this on a town-by-town basis and perhaps giving those towns some discretion not to move to phase three, to stay at phase two,” Lamont said at a news conference.

Connecticut’s third reopening phase started Thursday. It increases indoor restaurant and personal service capacity from 50 to 75 percent. It also increases capacity at private social commercial gatherings like weddings as well as religious services, graduation ceremonies, outdoor entertainment and indoor performing arts.

The discretion to stay or roll back to phase two would be given if a town reached 15 coronavirus cases per 100,000 residents over a two-week rolling average. The state average is closer to seven per 100,000.

The eastern part of the state and particularly New London County is beginning to see a rise in cases. Norwich and New London have more than 25 cases per 100,000 residents over a two-week average. Windham and Preston have between 15 and 24 cases per 100,000 residents. Those figures don’t include nursing homes, assisted living or correctional facilities.

The nature of the pandemic has changed since March and April where large swaths of the state were experiencing outbreaks, Lamont said. Many coronavirus outbreaks are being fueled by small private social gatherings where people get lax with mask use and social distancing.

Danbury’s outbreak that dated back to late August has been cooling off. Danbury’s outbreak occurred in one section of the city and mainly stayed there, said Department of Public Health Commissioner Dr. Deidre Gifford. Norwich and New London’s outbreaks aren’t as localized, she said.

The state’s rapid response testing team will help bring additional testing capacity to communities hit with coronavirus outbreaks. The team was active in Norwich last weekend and is partnering with the Ledge Light Health District in New London to bring additional testing to the area.

See also: CT Coronavirus Spread Different Now Than March: White House’s Dr. Deborah Birx

This article originally appeared on the Across Connecticut Patch

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