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Bayer’s BlueRock Reports Positive Early Data for Parkinson’s Stem Cell Therapy

By Heather McKenzie https://www.biospace.com/ Bayer logo on a building under blue sky/Getty Images, Kena Betancur/VIEWpress/Corbis Bayer subsidiary BlueRock Therapeutics has taken another next step in its bid to bring a potentially curative therapy to Parkinson’s disease patients. Wednesday, the companies reported that bemdaneprocel, a stem cell therapy, was well tolerated with no major side effects in a Phase I study. Topline data from the trial of 12 patients also showed feasibility of transplantation and evidence that the cells survived and engrafted in the brain after one year, satisfying the study’s secondary endpoints. Full data will be presented in August at the 2023 International Congress on Parkinson’s Disease and Movement Disorders in Copenhagen. The therapy, also known as BRT-DA01, is the first to show positive results in a Phase I study for Parkinson’s, according to Bayer. Bemdaneprocel consists of dopamine-producing neurons derived from pluripotent stem cells. In Parkinson’s disease, patients lose ...
- Source: drugdu
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- June 30, 2023
Vitamin D supplements may reduce risk of serious cardiovascular events in older people

Vitamin D supplements may reduce the risk of major cardiovascular events such as heart attacks among people aged over 60, finds a clinical trial published by The BMJ. The researchers stress that the absolute risk difference was small, but say this is the largest trial of its kind to date, and further evaluation is warranted, particularly in people taking statins or other cardiovascular disease drugs. Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels and is one of the main causes of death globally. CVD events such as heart attacks and strokes are set to increase as populations continue to age and chronic diseases become more common. Observational studies have consistently shown a link between vitamin D levels and CVD risk, but randomized controlled trials have found no evidence that vitamin D supplements prevent cardiovascular events, possibly due to differences in trial design that ...
- Source: drugdu
- 196
- June 30, 2023
Living near green space makes you 2.5 years younger

City parks and green spaces help counter heat, boost biodiversity, and instill a sense of calm in the urban jungle. They also help slow biological aging, with people who have access to green spaces found to be on average 2.5 years biologically younger than those who do not, according to a new study published Wednesday in Science Advances. “Living near more greenness can help you be younger than your actual age,” Kyeezu Kim, the study’s lead author and a postdoctoral scholar at Northwestern University’s Feinberg School of Medicine, told AFP. “We believe our findings have significant implications for urban planning in terms of expanding green infrastructure to promote public health and reduce health disparities.” Exposure to green spaces has previously been linked with better cardiovascular health and lower rates of mortality. It’s thought that more physical activity and social interactions are at play, but whether parks actually slowed down aging ...
- Source: drugdu
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- June 30, 2023
FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

Dive Brief: Regeneron Pharmaceuticals is facing a delay for a much-anticipated new version of its best-selling eye medicine after failing to win U.S. approval on Tuesday because of a manufacturing issue. The Food and Drug Administration issued a complete response letter for the high-dose version of Eylea, citing inspection findings at a third-party facility that fills vials of the medication. Regeneron said it’s working with the FDA and the third party to resolve the issues “as quickly as possible.” Importantly, the FDA did not cite any issues with the drug’s safety or efficacy and isn’t asking for new clinical trials. The agency also did not find any issues with the labeling or manufacturing of the actual drug substance, Regeneron said. Dive Insight: While the issue sounds relatively minor, any delay is significant for Regeneron, and the company’s shares tumbled around 11% during trading sessions on Tuesday and Wednesday. Eylea is ...
- Source: drugdu
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- June 30, 2023
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
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- 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
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- 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
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- 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
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- 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

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