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Large teaching hospital in the Netherlands relies on precision dosing platform for point-of-care decision support and immunology research SAN FRANCISCO, Dec. 13, 2022 /PRNewswire/ -- Today InsightRX, a precision dosing intelligence company, announced that Máxima Medical Center (MMC), a 600-bed teaching hospital in the Netherlands, is using its cloud-based precision dosing platform to support its clinical practice and immunology research. The center relies on the InsightRX Nova platform to support accurate therapeutic drug monitoring of the antibiotic drugs vancomycin and aminoglycoside for adults, children, and neonates. Through an innovative research partnership, InsightRX Nova also provides MMC with precision dosing support and analytics for the monoclonal antibodies infliximab and adalimumab, used in the treatment of Inflammatory Bowel Disease (IBD). InsightRX Nova relies on patient-specific data, pharmacokinetic/pharmacodynamic (PK/PD) models, and Bayesian forecasting to help clinicians make treatment decisions that reflect each patient's unique pharmacological profile. By using precision dosing on the InsightRX Nova platform to recommend optimal doses from just one blood sample, MMC's hospital pharmacists can rapidly achieve the correct therapeutic exposure for drugs like vancomycin, improving treatment efficacy and impacting patient safety. Inadequate dosages of vancomycin can be ineffective and lead to possible resistance, while excessive dosages can cause acute kidney injuries. "Ten years ago, many physicians still believed in the one-dose-fits-all principle. Now, the days of simply doubling the dose when patients prove nonresponsive to treatment are over," said Luc Derijks, PharmD, PhD, clinical pharmacologist at Máxima Medical Center. "We use InsightRX Nova to predict the optimal drug dose and drug interval for our patients treated with monoclonal antibodies for IBD, which is critical for improving outcomes, both in adults and in children." Founded in 2002, MMC is comprised of two hospitals in the cities of Eindhoven and Veldhoven in southern Netherlands. As a teaching facility, MMC supports 18 specialist residencies and conducts pharmacological research in various areas, with an emphasis on personalized medicine in immunology, especially IBD. In addition to its immunology research, the center's partnership with InsightRX also enables research on the immunosuppressants tacrolimus and methotrexate; the antibiotics flucloxacillin, piperacillin, and meropenem; sunitinib, a kinase inhibitor; voriconazole, an azole antifungal; and the anti-hemophilic Factor VIII. "Despite the complexity of its algorithms, InsightRX Nova is a very intuitive decision support tool, with an interface that's easy to master," said Derijks. "After residents spend time here, using the software to calculate the area under the curve and achieve target exposure, they return to their own hospitals inspired by what personalized medicine can do." In the near future, MMC plans to implement InsightRX Apollo Silver Analytics, a real-time analytics platform which allows organizations to investigate their own therapeutic drug monitoring data imported from InsightRX Nova. The MMC team will be able to compare the performance of various a priori and a posteriori PK/PD models within its own patient population to determine the optimal models to use for empiric dosing selection and level-guided dosing. "We look forward to a long partnership with Máxima Medical Center, which has embraced the benefits of both reactive and proactive therapeutic drug monitoring," said Sirj Goswami, CEO and co-founder of InsightRX. "We are fortunate to be working with such a strong international community of pharmacologists, researchers, and clinical residents to expand the impact of precision dosing on patients around the world." About InsightRX ‍InsightRX is a healthcare technology company that has developed a cloud-based platform for precision medicine and clinical analytics designed to individualize treatment at the point of care. The platform leverages patient-specific data, pharmacology models, and machine learning to understand each patient's unique pharmacological profile and can be integrated seamlessly within a clinical workflow. Media Contact Megan Moriarty Amendola Communications for InsightRX 913.515.7530 [email protected] SOURCE InsightRX

Smith Collection/Gado/Getty Images The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns. The drug is given in a single-dose as a 30-mintue intravenous infusion. This approval is specifically for the treatment of ABSSSI caused by certain susceptible Gram-positive bacteria in children, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This is not the only recent approval for this indication. In March 2021, the FDA approved Melinta Therapeutics’ Kimrysa for that indication, which became available this month. That is a one-hour, single-dose regimen approved for adults. ABSSSI affect about 14 million people in the U.S. annually, resulting in more than 3 million emergency room visits. They cause U.S. hospitals about $4 billion annually, with a 4-day average length of stay. ABSSSI are common, but can be life-threatening, particularly in children. The most common types of skin infections seen by pediatricians are cutaneous abscesses and cellulitis. In the U.S., ABSSSI causes 3 million pediatric visits to doctors or emergency rooms each year. “Serious infections in children can be difficult to treat and the impact of ABSSSI in children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. “This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.” The approval was built on data from a trial that evaluated Dalvance in pediatric patients from newborn to less than 18 years of age with ABSSSI, as well as three pharmacokinetic studies. In the clinical trial, the safety and efficacy were tested along with intravenous vancomycin for methicillin-resistant Gram-positive infections, or intravenous oxacillin or flucloxacillin for methicillin-susceptible Gram-positive infections. The analysis in the pediatric trial was on 183 patients with ABSSSI in the Modified Intent-to-Treat (mITT) population. That included all the patients who had been randomized to receive any dose of the drug who had ABSSSI caused by Gram-positive bacteria. They looked at an early clinical response at 48 to 72 hours based on a greater than or equal to 20% decrease in size of the lesions compared to baseline as well as on the need for rescue antibacterial therapy for children who were three months of age and older. In the study, 97.3% of patients in the Dalvance single-dose arm demonstrated an early clinical response, and 93.6% had an early clinical response in the two-dose arm, while 86.7% did in the comparator arm. The safety data in the children was similar to what was seen in adults. The drug is a second-generation, semi-synthetic lipoglycopeptide. It is made up of a lipophilic side-chain attached to an enhanced glycopeptide backbone. Dalvance is approved for adults with ABSSSI caused by susceptible Gram-positive bacterium, such as Staphylococcus aureus, including MRSA, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis. It was first approved for adults with skin infections in May 2014. At that time it was developed by Durata Therapeutics. Durata was acquired by Actavis in 2014 for $675 million. Actavis acquired Allergan in 2015 and changed the company name to Allergan. AbbVie completed its acquisition of Allergan in May 2020 in a deal worth about $63 billion.