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Nanexa AB, a pioneering pharmaceutical company, has unveiled a significant advancement in the realm of drug delivery. The company recently revealed exciting results from its Phase 1 study, designated NEX-20-01, which underscored the controlled release of lenalidomide in varying doses over a span of up to 21 days.
Atomic Layer Deposition (ALD) is a cutting-edge technique used in medical and pharmaceutical applications, particularly in the development of Nanexa's PharmaShell® technology. ALD's precision in depositing thin layers of materials plays a vital role in creating the controlled-release shell of PharmaShell®. This nanoscale engineering ensures accurate drug delivery, regulating release rates and optimizing therapeutic effects. PharmaShell® benefits from ALD's versatility, enhancing drug efficacy, minimizing side effects, and allowing tailored treatment plans. ALD's role in crafting PharmaShell® exemplifies its impact in advancing drug delivery systems, revolutionizing pharmaceutical care.
The study, conducted with great precision and care, involved nine healthy volunteers who were administered either one or two subcutaneous single injections of the innovative NEX-20A formulation. This formulation encompassed doses ranging from 15 to 35 mg of lenalidomide, with a maximum cumulative dosage of 50 mg. The outcome was nothing short of remarkable, as the observed pharmacokinetic data from the human participants correlated excellently with the projected exposure calculated from preclinical studies.
Central to the accomplishment was the remarkable release mechanism employed by Nanexa, known as PharmaShell®. This ingenious approach ensured a controlled and gradual release of the drug into the participants' bodies, creating a plasma curve that spanned an impressive 21 days. A critical observation from the study was the initial low release of the total dosage within the first day. This gradual release strategy plays a pivotal role in maintaining optimal levels of the drug in the bloodstream throughout the treatment period.
Equally encouraging was the confirmation that the total exposure of lenalidomide in the plasma—measured as the area under the curve (AUC)—escalated proportionally with the administered dose. This finding aligns with the expectations and demonstrates the efficacy of the PharmaShell® system in achieving the desired therapeutic outcomes.
Nanexa's CEO, David Westberg, expressed his enthusiasm regarding this groundbreaking achievement. "This is an important achievement for Nanexa, to once again demonstrate that we can predict the release profile of PharmaShell® in humans based on preclinical data," he shared. Westberg also revealed the company's forward-looking plans, stating, "We are now continuing to optimize the formulation and are ready to plan for the next clinical study of NEX-20 in patients. In that study, where we plan to increase the dose, we want to ensure that we will continue to minimize local reactions, and we see good results from preclinical studies on how this can be done."
Safety, of course, remains a top priority in such endeavors. Nanexa is committed to compiling comprehensive safety and tolerability data, which will be meticulously assessed following the final follow-up visits for the last dose group in October. Encouragingly, the study thus far has reported limited and transient injection site reactions, with no unexpected severe or systemic side effects. This bodes well for the continued development and progress of the NEX-20 project.
Nanexa's accomplishments in the controlled release of lenalidomide mark a significant milestone not only for the company but also for the entire field of pharmaceuticals. The ability to meticulously regulate the release profile of drugs while simultaneously minimizing undesirable side effects holds great promise for revolutionizing patient care and treatment outcomes. As Nanexa continues to pave the way with its innovative approach, the future of pharmaceuticals looks more promising than ever.
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