PharmaFocus Today – Page 337 – media

Sanofi’s amlitelimab shows promise in phase 2b atopic dermatitis trial

Sanofi has announced positive results from a phase 2b trial of amlitelimab in adults with moderate-to-severe cases of atopic dermatitis, one of the most common inflammatory skin diseases. Typically referred to as eczema, atopic dermatitis affects an estimated 16.5 million adults in the US, with nearly 40% affected by moderate-to-severe cases. The disease causes itchy, red, swollen and cracked skin, usually affecting the folds of the arms, back of the knees, hands, feet, face and neck. Sanofi’s amlitelimab is an investigational anti-OX40-ligand monoclonal antibody that is designed to rebalance the immune system by blocking inappropriate activation and proliferation of pro-inflammatory effector T cells and promoting expansion of anti-inflammatory regulatory T cells. The company says the candidate “has the potential to be a first-in-class treatment for a range of immune-mediated diseases and inflammatory disorders”, including moderate-to-severe atopic dermatitis and asthma. The dose-ranging STREAM-AD study has been evaluating amlitelimab in adult patients ...
- Source: drugdu
- 206
- June 30, 2023
Cellusion shares pipeline update for eye disease stem cell therapy

Cellusion plans to begin a Phase I/II trial for its bullous keratopathy candidate CSL-001 in 2024, says CEO Shin Hatou. After this, the company will begin a US Phase I/II study for the therapy in 2025, notes Hatou. The Tokyo, Japan-headquartered company aims to submit an investigational new drug (IND) application to the US Food and Drug Administration (FDA) in 2025. Hatou says the company may look to increase funding in the next few years either through further financing rounds or a possible initial public offering. Cellusion would be interested in continuing to work with its current investors and remains open to new investment opportunities to achieve this, he adds. Takuya Kaneko, Cellusion’s chief financial officer (CFO), says that the company aims to launch sales of CSL-001 in Japan by 2027. He says the company is looking for an alliance partner to support the product’s development in the US and ...
- Source: drugdu
- 103
- June 30, 2023
AbbVie, Genmab’s Epkinly shows promise in follicular lymphoma. Will FDA get on board?

Merely a month into an FDA approval, AbbVie and Genmab’s bispecific drug Epkinly has chalked up a positive readout that might enable an expansion in blood cancer, although the exact regulatory path remains unclear. Epkinly significantly beat back tumors in 82% of patients with relapsed or refractory follicular lymphoma in a phase 1/2 trial, the companies said Tuesday. The patients had received a minimum two—and a median three—prior lines of systemic therapy. The median duration of response hasn’t been reached in Epkinly’s study, and investigators are still following patients. The companies also didn’t disclose the complete response rate. Full results from the study will be shared at a future medical meeting. Epkinly snagged an FDA approval for previously treated diffuse large B-cell lymphoma (DLCLC) in May, and AbbVie and Genmab said they will talk to regulators about next steps in FL, an indolent form of lymphoma. If approved in the ...
- Source: drugdu
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- June 30, 2023
FDA Warms Up to Ipsen’s Post-Hoc Analysis for Rare Disease Drug Ahead of Adcomm

By Tristan Manalac https://www.biospace.com/ Despite a risk of bias and false positives, the FDA appears to be open to considering Ipsen’s post-hoc analysis of a Phase III study to support the approval of its investigational therapy palovarotene, proposed for the ultra-rare disease fibrodysplasia ossificans progressive. Ipsen is seeking approval for a once-a-day, 5-mg dose of palovarotene, along with a flare-up regimen consisting of a 20-mg once-daily schedule for the first four weeks followed by 10-mg once-daily for eight weeks, according to the company’s briefing document posted ahead of an Endocrinologic Drugs Advisory Committee meeting scheduled Wednesday. To support its regulatory bid, Ipsen provided data from one Phase II study with multiple open-label extension phases and a single-arm, open-label Phase III study, which used an external natural history control. However, according to the FDA’s briefing material, palovarotene failed its Phase III study, which “crossed the prespecified futility boundary at the second ...
- Source: drugdu
- 113
- June 29, 2023
Sanofi’s $1.4B Bet Pays Off with Promising Phase II Eczema Data

By Tristan Manalac https://www.biospace.com/ Pictured: Atopic dermatitis patient scratches their arm/iStock The company announced Tuesday that topline data from the Phase IIb STREAM-AD trial showed that Sanofi’s investigational antibody amlitelimab met the study’s primary outcome and strongly eased symptoms in patients with moderate-to-severe atopic dermatitis. After 16 weeks of treatment, patients in the amlitelimab group saw significant improvements in their average Eczema Area and Severity Index (EASI) scores compared to placebo. Amlitelimab retained its statistical edge over the placebo across all four studied doses. Sanofi’s candidate also cleared the study’s key secondary endpoints, including biomarker measurements, which suggested that amlitelimab had therapeutic effects on both type 2 and non-type 2 inflammatory pathways, according to the company’s news release. Improvements in primary and secondary measures persisted through 24 weeks of follow-up. These Phase IIb results support amlitelimab’s mechanism of action and indicate that “targeting OX40-Ligand has the potential to provide a ...
- Source: drugdu
- 165
- June 29, 2023
‘Aging’ immune cell levels could predict how well we respond to vaccines

Cambridge scientists have identified a signature in the blood that could help predict how well an individual will respond to vaccines. The discovery, published today in Nature Communications, may explain why, even among vulnerable patient groups, some individuals have better responses to vaccines than others. During the COVID-19 pandemic, it has become clear that some patients are better protected by vaccination than others. Many studies have shown that SARS-CoV-2 vaccines are less effective in people with weakened immune systems, but also that this effect is not uniform. Vaccination involves priming the immune system to look for—and get rid of—invading pathogens, such as viruses and bacteria. In part, this involves stimulating the production of antibodies uniquely programmed to identify a particular invader. These antibodies are themselves produced by a type of immune cell known as a B cell. One specific subset of B cells is known as age-associated B cells (ABCs). ...
- Source: drugdu
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- June 29, 2023
That essential morning coffee may be a placebo

For many people, the day doesn’t start until their coffee mug is empty. Coffee is often thought to make you feel more alert, so people drink it to wake themselves up and improve their efficiency. Portuguese scientists studied coffee-drinkers to understand whether that wakefulness effect is dependent on the properties of caffeine, or whether it’s about the experience of drinking coffee. “There is a common expectation that coffee increases alertness and psychomotor functioning,” said Prof Nuno Sousa of the University of Minho, corresponding author of the study in Frontiers in Behavioral Neuroscience and Field Chief Editor of the journal. “When you get to understand better the mechanisms underlying a biological phenomenon, you open pathways for exploring the factors that may modulate it and even the potential benefits of that mechanism.” A caffeine kickstart The scientists recruited people who drank a minimum of one cup of coffee per day and asked ...
- Source: drugdu
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- June 29, 2023
Illumina plans layoffs, closure of San Diego facility in push to save $100M a year

Dive Brief Illumina is laying off staff and closing a facility in San Diego as part of its push to cut its annual spending by $100 million, according to a regulatory filing. The layoffs, which STAT reports will affect 10% of R&D staff, come weeks after Francis deSouza resigned as CEO in the wake of a proxy battle with activist investor Carl Icahn. As well as exiting the San Diego site, Illumina is “evaluating its options” for another California campus in Foster City. The layoffs reportedly affect those two California sites, plus facilities in Wisconsin, Singapore and the United Kingdom. Dive Insight In April, Illumina outlined plans to reduce spending by $100 million this year. The goal was to improve margins and free up cash to invest in high-growth areas. Now, the company has revealed what the plan will mean for its workforce. Layoffs began last week and additional workforce ...
- Source: drugdu
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- June 29, 2023
Light or moderate alcohol consumption does not protect against endocrine conditions

People who have just one or two drinks per day are not protected against endocrine conditions such as obesity and type 2 diabetes, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Alcohol consumption is a significant public health concern because it is related to many medical conditions such as diabetes, obesity, liver conditions and heart disease. While it is widely accepted that excessive alcohol consumption causes a wide range of health issues, whether modest alcohol consumption has beneficial health effects remains controversial. Tianyuan Lu, (Ph.D., McGill University in Québec, Canada) said, “Some research has indicated that moderate drinkers may be less likely to develop obesity or diabetes compared to non-drinkers and heavy drinkers. However, our study shows that even light-to-moderate alcohol consumption (no more than one standard drink per day) does not protect against obesity and type 2 diabetes in the general ...
- Source: drugdu
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- June 29, 2023
Pfizer’s Litfulo approved by FDA as first treatment for adolescents with severe alopecia areata

Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata. Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body. The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata. Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options ...
- Source: drugdu
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- June 29, 2023

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