Magnesium Deficiency

PepGen disclosed that two patients in the 10-mg/kg cohort had reported asymptomatic magnesium deficiency.\n While PepGen works to persuade the FDA to let it launch a phase 2 trial of its Duchenne muscular dystrophy (DMD) therapy in the U.S., the biotech has decided to pause the U.K. arm of the study.The CONNECT2-EDO51 trial, which is designed to test PepGen’s PGN-EDO51 exon-skipping therapy over 25 weeks in patients with DMD, was placed on hold by the FDA in December. The following month, PepGen disclosed that two patients in the 10-mg/kg cohort had reported asymptomatic magnesium deficiency, although their magnesium levels had since returned to baseline levels after receiving oral magnesium supplements.Now, PepGen has decided to pause the U.K. arm of the study while it considers any lessons from a separate phase 2 study, dubbed CONNECT1, that’s ongoing in Canada. The first two cohorts of the Canadian study have been fully enrolled, with a readout expected in the third quarter. Health Canada has previously been in touch with PepGen to ensure it addressed the regulator’s safety concerns. The company said today that it hasn’t observed any new safety issues in its trials.“With our 10 mg/kg cohort of CONNECT1 study fully enrolled and data expected later this year, we decided to pause CONNECT2 until we are able to review results from the 10 mg/kg cohort in patients with DMD,” PepGen CEO James McArthur, Ph.D., said in the March 4 release.“This will allow us to gather additional safety data, assess the impact of this dose of PGN-EDO51 on dystrophin levels, and potentially improve the design of CONNECT2,” McArthur continued.PepGen will also “rapidly advance” studies of its antisense oligonucleotide therapy PGN-EDODM1 in myotonic dystrophy type 1. A phase 1 trial of the therapy endured its own FDA hold back in 2023 but has since gone on to post what PepGen described last week as “encouraging initial clinical data.” 

MONDAY, Aug. 19, 2024 -- Low levels of magnesium with or without high homocysteine (Hcy), are associated with increased DNA damage, according to a study recently published in the European Journal of Nutrition . Varinderpal S. Dhillon, Ph.D., from the University of South Australia in Adelaide, and colleagues examined whether magnesium deficiency alone or in conjunction with Hcy induces DNA damage in vivo in a study involving 172 healthy middle-aged adults. Magnesium, Hcy, folate, and vitamin B 12 blood levels were measured. Three DNA damage biomarkers were examined in peripheral blood lymphocytes: micronuclei (MN), nucleoplasmic bridges (NPBs), and nuclear buds. The researchers observed significant inverse correlations between magnesium and Hcy. Magnesium was positively correlated with folate and vitamin B 12 . Significant inverse correlations were seen for magnesium with MN and NPBs. Compared with those with high magnesium and low Hcy, individuals with low magnesium and high Hcy exhibited a significantly higher frequency of MN and NPBs. An interactive effect was seen between these two factors in induced MN and NPBs. "The results we present regarding the DNA protection effects of magnesium could benefit clinicians and nutritionists in patient counselling regarding food supplementation; if properly implemented, [they] could impact the onset or progression of cancer and other noncommunicable disease," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

High Levels of Intracellular Magnesium Promote a Large Number of Weak Synaptic Configurations, Optimal for Encoding New Information and Learning WALNUT CREEK, CA. / ACCESSWIRE / May 30, 2024 / Neurocentria Inc., a privately held late-stage biotechnology company developing novel therapies for Alzheimer's disease, Attention Deficit Hyperactivity Disorder (ADHD), Major Depressive Disorder (MDD) and other neurodegenerative and neuropsychiatric disorders, has published a novel research paper identifying magnesium's key role in synaptic and cognition regulation. Magnesium, an essential mineral, plays a vital role in brain function and cognitive health, according to groundbreaking research published in Nature Communications. The study, conducted by neuroscientists from Neurocentria and Tsinghua University, provides novel insights into how magnesium levels in the brain control the organization and strength of synaptic connections between neurons. The findings show that high levels of intracellular magnesium promote a large number of weak synaptic configurations optimal for encoding new information and learning. Conversely, low magnesium levels lead to fewer but stronger synaptic configurations better suited for memory storage. Notably, aging brains tend to have synapses organized in this low-magnesium, strong-synaptic configuration, impairing the ability to learn and form new memories. "Our study not only deepens the understanding of magnesium's critical roles in normal brain function but also bolsters our belief that intracellular magnesium could be a revolutionary new drug target for treating neurological disorders," said Dr. Guosong Liu, Neurocentria's co-founder and CEO. Previous research highlighted magnesium's importance for brain function - specifically, cognition and emotional regulation. Half the world's population has a magnesium deficiency, which worsens with age. Maintaining normal or elevated brain magnesium levels may significantly slow age-related cognitive decline and potentially prevent or treat diseases impacting cognitive function. Neurocentria is developing NRCT-101SR, designed to promote magnesium delivery into the brain's synaptic terminals. NRCT-101SR has been shown to improve learning and memory and emotional regulation in multiple clinical trials conducted in older adults with mild cognitive impairment, Alzheimer's disease and other neurological and neuropsychiatric disorders. "We are currently conducting multiple late-stage clinical trials to test the benefits of elevating brain magnesium for treating ADHD, depression, and other conditions," added Dr. Liu. To learn more, visit neurocentria.com. About Neurocentria Neurocentria is a late-stage biotechnology company dedicated to discovering and developing novel treatments for neurodegenerative and neuropsychiatric disorders, including Alzheimer's disease, ADHD, and depression. Since 2004, Neurocentria's team has been innovating breakthrough therapies to address the pathophysiology of these disorders, prevent their progression or even reverse their course, reduce symptoms and improve performance and quality of life for those in need. Forward-Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. 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Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of our drug candidates, including NRCT-101SR, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for our programs to continue to develop; our ability to protect our intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect our products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital that will be necessary to complete the clinical trials that we have initiated or plan to initiate. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. For further information, contact Guy Bar-Klein at gbar-klein@neurocentria.com. Contact Information Guy Bar-Klein Executive Director of Research & Strategy gbar-klein@neurocentria.com +1 (925) 954-4868 Related Files Neurocentria - Nature comm News release - 30May2024 SOURCE: Neurocentria, Inc. View the original press release on newswire.com.