Tacrolimus

SAN FRANCISCO, Dec. 3, 2024 /PRNewswire/ -- InsightRX – the leader in Bayesian model-informed precision dosing (MIPD) software – today announced it will attend the ASHP 2024 Midyear Clinical Meeting & Exhibition as both an exhibitor and presenter. The meeting is scheduled for Dec. 8-12 at the Ernest N. Morial Convention Center in New Orleans. ASHP 2024 is organized by the American Society of Health-System Pharmacists and will include vendor exhibits, educational sessions, poster presentations, and networking opportunities for pharmacy professionals. Representatives from the InsightRX team will be at booth 1340 in the exhibition hall (available on Monday Dec 9 and Tuesday Dec 10 from 11am - 3pm, and Wed Dec 11 from 11am - 2pm) to meet with visitors and discuss product updates, new features, and benefits of Bayesian MIPD adoption. Additionally, InsightRX Senior Director of Product & Customer Experience Jonathan Faldasz, PharmD, BCPS, will present a poster from the InsightRX team on Monday, Dec. 9, from 2-3:30 p.m. The title of the poster is Proposed Update to the Cockcroft-Gault Equation for Patients with Low Serum Creatinine: Results from a Massive Multi-Site Dataset. This study evaluated the accuracy of the Cockcroft-Gault equation–long regarded as the gold standard for estimating renal function–in patients with serum creatinine levels below 1 mg/dL. By analyzing data from nearly 100,000 patients, the InsightRX team identified significant inaccuracies in the equation's predictions for this population. In response, they developed a modified equation incorporating adjusted serum creatinine, which demonstrated greatly improved accuracy. The poster will detail these findings and their implications for clinical practice. Front and center will be demonstrations of a new feature to the Nova platform, InsightRX Gemini, designed to eliminate complexities of manual PK model selection. InsightRX Gemini automatically chooses the best-performing PK model for the patient, based on four common covariates, and was built analyzing approximately 400,000 vancomycin treatment courses contained in the Nova data lake. When compared to commonly available PK models (seen in "freeware" and various other applications), InsightRX Gemini: increases dosing accuracy for individual patients up to 47.2% increases precision by up to 25% decreases bias by up to 93% Overall, MIPD dosing activities have increased for a variety of therapeutic areas and hold promise for enhancing workflows and producing more accurate dosing and improved outcomes. In addition to vancomycin, InsightRX offers numerous other Drug Modules, which the team will also present at the exhibition. Several of these were highlighted in recent studies, thought leadership articles, and blog posts by the InsightRX team over the past year, including: Antifungals – Posaconazole is a pharmacotherapeutic pillar for prophylaxis and treatment of invasive fungal diseases. Dose individualization is critical to achieving adequate antifungal exposure associated with improved outcome. InsightRX validated an MIPD strategy for posaconazole for its fit-for-purpose, an important first step toward dosage optimization with the goal to improve antifungal treatment in clinical practice. Beta-lactams – Therapeutic drug monitoring (TDM) can improve PK/PD target attainment of beta-lactam levels and optimize dosing in vulnerable populations. There are still several barriers to widespread adoption of TDM of beta-lactams into routine clinical practice, however, beta-lactam TDM has great potential to improve patient care by optimizing antibiotic dosing, especially in high-risk populations. Solid organ transplant – Therapeutic drug monitoring is essential with tacrolimus, one of the key immunosuppressive agents used after solid organ transplant. Although most transplant centers rely on trough concentrations drawn immediately before the dose, evidence shows a poor correlation between tacrolimus trough concentrations and outcomes. A 2019 tacrolimus guidance document concludes that Bayesian estimation may be a better way to improve future tacrolimus TDM. Bone marrow transplant – Dose personalization improves patient outcomes for many drugs with a narrow therapeutic index and high inter-individuality variability, including busulfan. In a simulated study, InsightRX demonstrated that while area under the curve (AUC) estimates between the two methods showed good correlation, the maximum a posteriori Bayesian (MAP) approach led to higher target attainment for busulfan dosing. Anticoagulants – Heparin is a lifesaving mainstay of anticoagulation in patients at high risk of coagulation-related morbidity and mortality. Yet most hospitals struggle to keep their patients at a target heparin exposure, which can result in increased morbidity and mortality from both clotting and bleeding events. Several exciting advances in the use of MIPD for heparin would allow clinicians to better individualize therapy for each treatment course. Inflammatory bowel disease – Efficacy of infliximab in children with inflammatory bowel disease can be enhanced when serum concentrations are measured and further dosing is adjusted to achieve and maintain a target concentration. A recent collaborative study showed that a population pharmacokinetic model may help to predict an individual's infliximab dose requirement. "InsightRX has enjoyed a year of real growth and accomplishment and we're excited to meet with our colleagues at ASHP in New Orleans to discuss what we've learned and how we plan to continue improving dosing safety and accuracy," said Sirj Goswami, PhD, CEO and cofounder of InsightRX. "Model-informed precision dosing holds great promise for contributing to better clinical outcomes and operational efficiency." About InsightRX InsightRX is a healthcare technology company providing a cloud-based clinical decision support platform that applies quantitative pharmacology and AI to enhance therapeutic decision-making from phase I drug development to point of care. The company's platform provides an individualized, predictive understanding of a patient's response to treatment which enables an enhanced understanding of dose-effect response and toxicity for clinicians to improve medication effectiveness. Media Contact Michelle Noteboom Amendola Communications for InsightRX [email protected] SOURCE InsightRX WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Peer-reviewed article highlights potential treatment for OLP with focus on localized drug deliveryPITTSBURGH, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company dedicated to addressing serious diseases with significant unmet needs, today announced the publication of a peer-reviewed paper in CUREUS. Titled “Rationale for the Use of Topical Calcineurin Inhibitors in the Management of Oral Lichen Planus and Mucosal Inflammatory Diseases,” the paper focuses on non-steroid treatments for oral lichen planus (OLP), particularly topical calcineurin inhibitors (TCIs) such as tacrolimus. TCIs are non-steroidal medications used to treat inflammatory and autoimmune conditions by targeting the enzyme calcineurin, critical for T-cell activation and cytokine production. The publication also explores advanced drug delivery systems designed to address the challenges of treating chronic inflammatory conditions like OLP. The paper emphasizes the potential of Lipella’s investigational therapy, LP-310, a novel oral rinse formulation of LP-10 (tacrolimus) specifically designed to provide localized therapeutic effects for OLP while minimizing systemic exposure. LP-310 is currently being evaluated in a Phase 2a multicenter clinical trial focused on safety, tolerability, and efficacy in adult patients with symptomatic OLP. Dr. Michael Chancellor, Lipella’s Chief Medical Officer and author of the paper, commented, “Oral lichen planus is a chronic inflammatory condition that significantly impacts patients' quality of life. Traditional therapies, primarily topical corticosteroids, often lead to undesirable side effects with long-term use. Our research emphasizes the promise of TCIs, such as tacrolimus, as effective alternatives that may offer a steroid-sparing approach. This peer-reviewed paper represents an important next step in advancing a potential breakthrough treatment option for OLP, aiming to address the unmet needs of patients with this challenging condition.” The publication details the underlying mechanisms of OLP, the role of TCIs in treatment, and emerging therapies such as topical liposomal formulation of tacrolimus designed to optimize local drug delivery while reducing systemic exposure. About Oral Lichen Planus (OLP) Oral Lichen Planus (OLP) is a chronic inflammatory condition that affects the mucous membranes inside the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue and open sores, OLP impacts approximately 6 million Americans and currently has no FDA-approved therapies. About LP-310 LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address oral lichen planus. Designed to provide localized therapeutic effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition. A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants. Top-line data is anticipated by the end of 2024, with the trial expected to conclude by mid-2025. For more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591. About Lipella Pharmaceuticals Inc.Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. Forward-Looking StatementsThis press release includes certain "forward-looking statements." All statements, other than statements of historical fact, included in this press release regarding, among other things, our strategy, future operations, financial position, prospects, clinical trials, regulatory approvals, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. 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They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, risks related to the effective application of the use of proceeds from the private placement, general capital market risks, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. In addition, the information contained in this press release is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this press release as legal, tax and financial advisors as to legal and related matters concerning the matters described herein. CONTACTJonathan KaufmanChief Executive OfficerLipella Pharmaceuticals Inc. Info@Lipella.com 1-412-894-1853 PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com