Rifabutin

RedHill has been selected to provide a presentation to further elaborate on opaganib's potential to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day" -- Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and the treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA -- The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND's mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations -- With multiple U.S. government collaborations for chemical and MCMs and pandemic preparedness, opaganib is a novel, host-directed, potentially broad-acting, orally administered small molecule, clinical-stage drug with demonstrated safety and efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases, and chemical and nuclear/radioprotection indications TEL-AVIV, Israel and RALEIGH, N.C., Oct. 28, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company has been selected to further elaborate on opaganib's[1] potential in a presentation to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) "Host Directed Therapeutics Industry Day". The meeting is scheduled to take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA. The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-CBRND mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations. Based on reviews, feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and treatment of exposure to viruses, bacteria and toxins. "Opaganib is already the subject of multiple ongoing collaborations with several U.S. government agencies. However, selection for presentation at this important governmental investment event provides a significant opportunity to highlight the growing body of evidence in support of opaganib's potential as an oral, host-directed, broad-acting viral, chemical and nuclear countermeasure ," said Guy Goldberg, RedHill's Chief Business Officer. About Opaganib (ABC294640) Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA). Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms. Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications. Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the U.S. government and shall not be used for advertising or product endorsement purposes. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[2]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first -in -class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for chemical and medical countermeasure and pandemic preparedness use, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential of opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Category: R&D [1]Opaganib is an investigational new drug, not available for commercial distribution. [2]Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. 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Oct. 22, 2024 (GLOBE NEWSWIRE) -- RespiriNTM Programme allows BioVersys’ NTM project to access up to €2 million of non-dilutive funding BioVersys taps into key expertise of the established RespiriNTM consortium members and will lead development of its candidates through preclinical and clinical studies BioVersys’ NTM candidates are derived from the company’s proprietary Ansamycin Chemistry platform and are being developed to address difficult-to-treat Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB) infections BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant ("MDR") bacteria, announced today that it has joined the EU-funded RespiriNTM programme, an 8-year journey exploring multiple approaches to determine new targets for anti-mycobacterial compounds, define and optimize novel inhibitors and move these through the process of hit-to-lead up until the First-in-Human trials. BioVersys’ in-house non-tubercular mycobacteria (NTM) project will have access to up to approximately €2 million in non-dilutive funding from the original IMI2 RespiriNTM grant of approximately €5.7 million, and to key capabilities of established consortium partners to develop novel candidates to address NTM pulmonary disease (NTM-PD). NTM-PD is estimated to affect more than 86,000 people in the US according to the American Lung Association and antimicrobial resistance (AMR) is a major global health threat with currently available therapeutics becoming more and more obsolete due to AMR.1 This is of greatest concern when addressing NTM-PD, as chronic antibiotic treatments of 12-24 months required for these infections often lead to the development of antibiotic resistance. Due to the lack of effective treatment options, current cure rates for NTM-PD are as low as 30-50%.2 Particularly vulnerable to NTM-PD are people who suffer from structural airway diseases such as cystic fibrosis, COPD and bronchiectasis. BioVersys’ NTM program is derived from the company’s proprietary Ansamycin Chemistry platform. The BioVersys’ research team is developing a novel and highly potent broad-spectrum anti-NTM ansamycin, suitable for oral or inhalation therapy that is devoid of cross-resistance with other therapeutic classes. Since NTM-PD patients are often on multi-drug regimens, the company focuses on developing molecules that do not show any significant potential for drug-drug interactions. Meindert H. Lamers, Associate Professor, Leiden University Medical Center & RespiriNTM Project Coordinator: "Working together with BioVersys on the RespiriNTM project is a unique opportunity. Their powerful ansamycin class of inhibitors have the potential to provide an effective and highly needed treatment option for NTM infections, which fits perfectly with the aims of the RespiriNTM project. BioVersys’ strong drive to deliver a novel NTM antibiotic has invigorated the RespiriNTM project. Our collaboration to date has been very stimulating and I am very much looking forward to deepening our collaboration with BioVersys over the coming years." Dr. Sergio Lociuro, Chief Scientific Officer of BioVersys: “Following on from the recent successes of TRIC-TB, we are very pleased to have the opportunity to join a second IMI2 JU funded programme, which is tackling another area of high unmet medical need. RespiriNTM is a strong consortium of many expert partners with valuable experience in the field of antimicrobial resistance. We aim to develop our broad-spectrum NTM candidates into effective treatments against these difficult to treat pulmonary diseases to positively impact patients' lives.” Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB) cause several hundreds of thousands of infections worldwide each year. Unlike the well know related species M. tuberculosis, there are currently limited and poor treatment options to address these pathogens with significant levels of relapse and unacceptably high mortality rates, approaching 45%.3 Therefore, there is an urgent need for antibiotics that can treat the debilitating diseases that are caused by the Non-Tuberculous Mycobacteria (NTM), M. avium complex and M. abscessus. The RespiriNTM project aims to develop novel antibiotics that target the RNA transcription machinery that is required for protein production in the cell. Through this work we aim to develop desperately needed antibiotics that work against M. avium and M. abscessus that form an increasing threat to global health. RespiriNTM is part of the IMI AMR Accelerator Programme. Non-tuberculous Mycobacteria (NTM) are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary disease (NTM-PD) caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB).4 NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia.4 Treatment of NTM infections is challenging due to variable intrinsic bacterial susceptibility, acquired resistance to commonly used antimicrobial agents, length of therapy (at least 12 months) and adverse effects associated with current treatment options. Macrolide-based, triple drug regimens, plus aminoglycosides for chronic/relapsing infections5 are considered only moderately effective for treating MAC, whereas no therapy of predictable efficacy exists for the treatment of M. abscessus, a pathogen associated with up to 50% mortality.6 People with predisposed conditions, including cystic fibrosis (CF), other lung diseases and immune-compromised patients are more easily colonised. Alarmingly, the incidence of NTM infections among people living with CF has increased from 3.3% to 22.6%, with MAB becoming a very prominent pathogen.7 Statements or views expressed in this release are of those of the respective organizations or persons and the IMI2 JU is not responsible for any use of the information contained herein. The RespiriNTM project has received funding from the Innovative Health Initiative 2 Joint Undertaking (JU) under grant agreement No 853932. This Joined Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The Innovative Medicines Initiative (IMI) IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It was set up to improve health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in healthcare research, including universities, pharmaceutical companies, other companies active in healthcare research, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. This approach has proven highly successful, and IMI projects are delivering exciting results that are helping to advance the development of urgently-needed new treatments in diverse areas. IMI projects are now managed by the Innovative Health Initiative (IHI), which builds on the successes of IMI and is a cross-sectoral public-private partnership involving a wider range of health industries. BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 2), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. 1 Lancet, Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, VOLUME 399, ISSUE 10325, P629-655, FEBRUARY 12, 2022 2 Wang et al., 2022; Novosad et al., 2017; Lee et al., 2021; Mourad et al., 2021 3 The Impact of Nontuberculous Mycobacteria Species on Mortality in Patients with Nontuberculous Mycobacterial Lung Disease. Wang et al, 2022, Frontiers in Microbiology. doi:10.3389/fmicb.2022.909274 4 Hamed KA & G. Tillotson “A narrative review of nontuberculous mycobacterial pulmonary disease: microbiology, epidemiology, diagnosis, and management challenges” Ex. Rev. Resp. Med. (2023), 17 (11), 973 - 988 https://doi.org/10.1080/17476348.2023.2283135 5 Daley CL et al. “Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline” Eur. Resp. J. (2020), 56, 2000535; https://doi.org/10.1183/13993003.00535-2020; Griffith DE et al. “An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases” Am. J. Respir. Crit. Care Med. (2007), 175, 367–416; https://doi.org/10.1164/rccm.200604-571ST 6 Jhun BW et al. “Prognostic factors associated with long-term mortality in 1445 patients with nontuberculous mycobacterial pulmonary disease: a 15-year follow-up study” Eur. Resp. J. (2020), 55, 1900798; https://doi.org/10.1183/13993003.00798-2019 7 Degiacomi G. et al. “Mycobacterium abscessus, an Emerging and Worrisome Pathogen among Cystic Fibrosis Patients” Int. J. Mol. Sci. (2019), 20, 5868; doi: 10.3390/ijms20235868 The content above comes from the network. if any infringement, please contact us to modify.