Colistin Sulfate

RODEN, Netherlands, Jan. 18, 2024 /PRNewswire/ -- PureIMS, a pharmaceutical company focused on the development of innovative inhalation products, this week reported it has completed a comparative pharmacokinetic study with Levodopa Cyclops®. The study results show rapid pulmonary absorption of levodopa in absence of safety and tolerability issues. These properties make Levodopa Cyclops® a prime candidate to treat Parkinson's Disease patients in OFF episodes and, by that, fulfill an unmet medical need. The study suggests a high comparability with a marketed inhaled levodopa product, which opens the path towards an abbreviated registration. To manage OFF episodes in Parkinson's Disease and their inherent debilitating motoric consequences, a high absorption rate and rapid Cmax are essential PK parameters that determine how fast patients are relieved from these motor disturbances. Levodopa Cyclops® has now demonstrated to possess these PK properties. In addition to the ideal PK performance, Levodopa Cyclops® has unrivaled ease of use in that it requires only two easy steps before use and does not need to be cleaned. This drastically improves its usability over other products for the intended, motorically impaired patient population. Pharmacodynamics of Levodopa Cyclops® were demonstrated in a phase II study in PD patients experiencing OFF episodes. A significant and clinically meaningful improvement of MDS-UPDRS-part III motor scores was already observed after 15-20 minutes. Based on the data from this comparative study, PureIMS is now gearing up for an abbreviated registration path, which was determined in consultation with the FDA. Also for the European market PureIMS has worked out the clinical development trajectory. For both the US and EMA, PureIMS solicits partners for development and commercialization. Prof. Dr. Teus van Laar, neurologist and clinical pharmacologist, UMC Groningen and Member of PureIMS' scientific advisory board: "This randomized cross-over trial of Levodopa Cyclops® vs. Inbrija® in 26 healthy volunteers has shown that Levodopa Cyclops® is at least as good and safe as Inbrija®, showing a quicker absorption of levodopa during the first minutes. Levodopa Cyclops® will be a valuable medicine that enables fast and reliable relieve to patients with Parkinson's disease suffering from OFF periods" Jaap Wieling, PureIMS' CEO commented: "It has already been very stimulating to hear the feedback of Parkinson's patients about the unrivaled ease of use of Levodopa Cyclops® from the previous phase I, II and usability studies. The data from this Levodopa Cyclops® comparative study are a confirmation of the company's expectations of the great dispersion capabilities of Cyclops® DPI and the benefits for a range of systemic and pulmonary diseases. It brings us in the next stage of the company's life cycle, where we will bring a range of pipeline products to the market and where we co-develop inhalable products for systemic and pulmonary indications with our pharma and biotech partners." About PureIMS B.V. PureIMS, a Netherlands-based pharmaceutical company, owns exclusive worldwide license rights of Cyclops®, a high-dose dry-powder patient-centric inhaler for rapid and controlled drug delivery, easy-to-use, comfortable, pre-filled, and disposable, ensuring high-dose delivery and a fast onset of action. The inhaler is a superior alternative to a wide range of oral and parenteral dosage forms for pulmonary, systemic and rescue indications. Recently the company closed collaborative agreements for the application of Cyclops™ in the development of therapeutics for NTM and IPF, for pulmonary diagnostic purposes and for inhaled vaccination. In addition to partnering programs, PureIMS has a clinical stage in-house pipeline also open to outlicensing; lead programs are Cyclops™ inhalers for levodopa (PD), epinephrine (anaphylaxis) and colistin (CF and NCFB). PureIMS' first product Colistin Cyclops™ to treat P. aeruginosa infection in CF patients, is already provided to patients as an extemporaneously compounded product, and first steps are taken to initiate full development for marketing in the US and Europe. With Cyclops®, for which single-use and multi-use alternatives are available, PureIMS has also enthused pharma/biotech companies looking for innovative pulmonary delivery options to develop inhaled small and large molecule products for local and systemic indications in early-clinical endeavors. The Cyclops™ technology is also ideally suited for 'rescue applications' in areas with an acute unmet need. Levodopa Cyclops® and Epinephrine Cyclops® are an exponent of this class of products. For more information, please visit For further inquiries, please contact: Jaap Wieling, CEO PureIMS bv Ceintuurbaan Noord 152 9301NZ RODEN, The Netherlands +31620335602 [email protected] SOURCE PureIMS

Bactericidal activity demonstrated in vitro and in vivo against broad range of Gram-negative bacteria, including multidrug-resistant strains Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an asset purchase agreement with Spexis AG (SIX: SPEX) for a preclinical program of antibiotics from a novel class, targeting Gram-negative bacteria, including multidrug-resistant strains.1 Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: “The acquired antibiotics are of a novel class, targeting the lipopolysaccharide transport in Gram-negative bacteria, which have been highlighted by the World Health Organization as priority pathogens against which new antibiotics are urgently needed. The convincing potent and rapid bactericidal activity against bacteria such as Escherichia coli or Klebsiella pneumoniae, including multidrug-resistant species, and the activity in infection models, is very encouraging. We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.” The antibiotics were developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program and selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria. This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria. Activity has been shown in vitro and in vivo against Enterobacteriaceae such as E. coli and K. pneumoniae, including strains resistant to beta-lactams and colistin, an antibiotic regarded as last-resort therapy. The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).2 This underscores the potential of this novel class of antibiotics. CARB-X is a global non-profit partnership dedicated to supporting early-stage antibacterial research and development, to address the rising threat of drug-resistant bacteria. Basilea is acquiring all program compounds, know-how and intellectual property and is paying Spexis up to a total of CHF 2 million, which consists of an upfront payment, a payment related to the transfer of the assets to Basilea, and a potential final milestone payment related to the availability of near-term external funding for the further development of the program. In addition, Basilea assumes the rights and obligations of Spexis, including potential low single-digit percentage royalties on sales, under licensing agreements. The transaction is subject to the approval by the Western District Court of the Canton Basel-Landschaft. Infections by multidrug-resistant Gram-negative bacteria (GNB) are a major challenge for healthcare professionals. Due to an additional outer cell membrane compared to Gram-positive bacteria, it is more difficult for antibiotics to get into the cell. In addition, this outer membrane carries lipopolysaccharides/endotoxins which induce inflammation and play an important amplifying role in the pathogenesis of infections by GNB and are therefore considered an important virulence factor. Moreover, GNB can acquire resistance to several classes of antibiotics such as carbapenems, fluoroquinolones, tetracyclines and earlier-generation cephalosporins, making infections with GNBs particularly difficult to treat. In 2017, the World Health Organization published a list of 12 classes of priority bacterial pathogens that pose the greatest threat to human health, of which nine classes are Gram-negative.3 Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. References M. Schuster, E. Brabet, K. K. Oi et al. Peptidomimetic antibiotics disrupt the lipopolysaccharide transport bridge of drug-resistant Enterobacteriaceae. Science Advances 2023 (9), eadg3683 Research reported in this press release is supported by CARB-X. CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed (Accessed: January 14, 2024) The content above comes from the network. if any infringement, please contact us to modify.