Lung Diseases, Parasitic

The USF Health and Tampa General Hospital pulmonary and critical care medicine program earned two national designations: as a founding member of the Foundation for Sarcoidosis Research Global Sarcoidosis Clinic Alliance and selection as a Pulmonary Fibrosis Foundation Care Center Network. TAMPA, Fla., Nov. 29, 2022 /PRNewswire/ -- Tampa General Hospital and USF Health are proud to announce that their collaborative pulmonology program has joined forces with two prestigious organizations that will improve the lives of patients globally — the Foundation for Sarcoidosis Research (FSR) Global Sarcoidosis Clinic Alliance and the Pulmonary Fibrosis Foundation Care Center Network. Continue Reading The USF Health and Tampa General Hospital pulmonary and critical care medicine program earned two national designations: as a founding member of the Foundation for Sarcoidosis Research Global Sarcoidosis Clinic Alliance and selection as a Pulmonary Fibrosis Foundation Care Center Network. (PRNewsfoto/Tampa General Hospital) The Tampa General Hospital Center for Advanced Lung Disease & Lung Transplant, where the USF Health/TGH pulmonary program is based, has become one of the founders to launch the FSR Global Sarcoidosis Clinic Alliance. It will have a worldwide impact on advancing sarcoidosis research and improve the lives of those with sarcoidosis through patient and clinician education, engagement, and support. The FSR Global Sarcoidosis Clinic Alliance brings together sarcoidosis clinics and hospitals, whose mission is to find a cure and offer evidence-based, patient-centric care for those living with sarcoidosis. The USF Health/TGH program is one of 22 esteemed founding members. Membership is offered to a select number of clinics that serve a high percentage of underserved communities. There are 1.2 million patients impacted by sarcoidosis, a disease characterized by the growth of tiny collections of inflammatory cells found in different parts of the body, but commonly found in the lungs and lymph nodes. Additionally, The Pulmonary Fibrosis Foundation announced that the USF Health/TGH pulmonology program has joined the Pulmonary Fibrosis Foundation Care Center Network, whose mission is to accelerate the development of new treatments and ultimately a cure for pulmonary fibrosis. The Pulmonary Fibrosis Foundation (PFF) is dedicated to promoting earlier recognition and diagnosis of pulmonary fibrosis and ensuring that patients receive the highest quality health care. As part of that commitment, the Foundation has worked with the pulmonary fibrosis medical community to establish the PFF Care Center Network, where people with pulmonary fibrosis can find experienced medical professionals who understand their disease and support services to improve the quality of their lives. Pulmonary Fibrosis is a disease in which the lungs become scarred (fibrosed) and damaged causing difficulty in breathing. "The TGH Center for Advanced Lung Disease & Lung Transplant is thrilled to be one of the founders of the FSR Global Sarcoidosis Clinic Alliance. Our goal is to bring world-class, innovative pulmonary care to the Tampa Bay region and beyond and provide our team with the ability to collaborate with research and make an impact in improving the outcomes and care of patients with sarcoidosis," said Dr. Debabrata Bandyopadhyay, director of interstitial lung disease and sarcoidosis, TGH Center for Advanced Lung Disease & Lung Transplant, and associate professor, internal medicine with USF Health Morsani College of Medicine. "We are also very proud to join the Pulmonary Fibrosis Foundation Care Center Network and partner with a stellar group of medical centers dedicated to improving the lives of those living with pulmonary fibrosis." Overall, USF Health faculty supporting the TGH Center for Advanced Lung Disease & Lung Transplant provide comprehensive care via state-of-the-art therapies and advanced diagnostic imaging and molecular tools. As part of a leading academic medical center, the TGH Center for Advanced Lung Disease & Lung Transplant's team of surgical and medical experts take a multidisciplinary approach, combining access to cutting-edge clinical trials and therapies with compassionate and personalized care. "Joining forces with these two outstanding organizations furthers our mission to provide world-class care and helps move us forward in achieving our vision of becoming the safest and most innovative academic health system in America," said Dr. Kiran Dhanireddy, vice president and chief, TGH Transplant Institute and surgical director, Liver Transplantation. "These alliances reflect our multidisciplinary team's deep dedication to research and innovation in providing vital care to lung patients globally." In addition to treating pulmonary fibrosis, idiopathic pulmonary fibrosis, and patients with sarcoidosis, the nationally renowned physicians with USF Health and the TGH Center for Advanced Lung Disease & Lung Transplants offer a range of multidisciplinary services to treat advanced-stage lung tumors, chronic obstructive pulmonary disease (COPD), chronic cough, chronic pulmonary disease, cystic fibrosis, lung disease, pulmonary hypertension, and pulmonary infections. ABOUT TAMPA GENERAL HOSPITAL Tampa General Hospital, a 1,040-bed, not-for-profit, academic medical center, is one of the largest hospitals in America and delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2022-23 Best Hospitals, and is tied as the third highest-ranked hospital in Florida, with seven specialties ranking among the best programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic medical center's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – first nationally in the 2022 America's Best Employers for Women and sixth out of 100 Florida companies in the 2022 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit worth more than $224.5 million in the form of health care for underinsured patients, community education, and financial support to community health organizations in Tampa Bay. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With six medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center, and its 32-bed Neuroscience, Intensive Care Unit is the largest on the West Coast of Florida . It also is home to the Jennifer Leigh Muma 82-bed neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health, and 21 TGH Imaging powered by Tower outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness to improve and better coordinate patient care at a lower cost. For more information, go to . ABOUT USF HEALTH USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health's multispecialty physicians' group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report's national university rankings than USF. For more information, visit health.usf.edu. SOURCE Tampa General Hospital

CAMBRIDGE, Mass., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced data presentations for 7 abstracts accepted at the Infectious Disease Society of America (IDSA) IDWeek™ 2022, taking place from October 19 – 23, 2022 in Washington, DC. Spero-affiliated presentations will showcase clinical and nonclinical data for tebipenem HBr, Spero’s oral antibiotic investigational candidate in development for the treatment of adults with complicated urinary tract infection (cUTI), including pyelonephritis, along with health outcomes and epidemiologic data highlighting the potential utility of tebipenem HBr to address unmet medical need. SPR206 will also figure prominently with in vitro analysis of target pathogens and clinical isolates, along with clinical data for SPR206 in healthy adult subjects supportive of further development in the treatment of pulmonary infections. Presentations pertaining to tebipenem HBr and SPR206: 1. Title: Clinical and Microbiological Outcomes for Enterobacterales Uropathogens in the Phase 3 ADAPT-PO Study of Oral Tebipenem Pivoxil HydrobromidePresenting Author: Ian A. Critchley, PhD (Spero Therapeutics)Poster Session: Clinical Trials, October 20, 2022; 12:15PM-1:30PM US ET; Poster #222 2. Title: Effectiveness of TBP-PI-HBr in Patients with Instrumentation, Anatomic or Functional Abnormalities: Secondary Analysis from ADAPT-POPresenting Author: Angela K. Talley, MD (Spero Therapeutics)Poster Session: UTIs, October 22, 2022; 12:15PM-1:30PM US ET; Poster #2236 3. Title: Enterobacterales Resistance Patterns for ESBL+ and MDR Urine Isolates Collected and Tested from 295 Outpatient Facilities in 2019Presenting Author: Mauricio Rodriguez, PharmD, MS-HEOR, BCPS, BCCCP, BCIDP (Spero Therapeutics)Poster Session: UTIs, October 22, 2022; 12:15PM-1:30PM US ET; Poster #2237 4. Title: The Economic Burden of Adverse Events Requiring Acute Care Services from Outpatient Parenteral Antibiotic Therapy (OPAT) TreatmentPresenting Author: Mauricio Rodriguez, PharmD, MS-HEOR, BCPS, BCCCP, BCIDP (Spero Therapeutics)Poster Session: Social Determinants of Health, October 21, 2022; 12:15PM-1:30PM US ET; Poster #1416 Selected for oral presentation at the Rapid-Fire Poster Session: Stewardship & Infection Control; Presentation #1488 5. Title: SPR206 Pharmacokinetics (PK) in Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) in Healthy Adult Subjects Presenting Author: Keith A. Rodvold, PharmD (University of Illinois Chicago)Poster Session: PK/PD Studies, October 20, 2022; 12:15PM-1:30PM US ET; Poster #625 6. Title: Activity of SPR206 and Comparator agents against Pseudomonas aeruginosa and Acinetobacter baumannii Causing Infections in the United States Hospitals Presenting Author: Rodrigo E. Mendes, PhD (JMI Laboratories)Poster Session: Antimicrobial Novel Agents, October 22, 2022; 12:15PM-1:30PM US ET; Poster #1676 7. Title: In Vitro Activity of SPR206 and Comparator Compounds Against Enterobacterales Isolates Responsible for Infections in United States HospitalsPresenting Author: Rodrigo E. Mendes, PhD (JMI Laboratories)Poster Session: Antimicrobial Novel Agents, October 22, 2022; 12:15PM-1:30PM US ET; Poster #1677 About Tebipenem HBr Tebipenem HBr (tebipenem pivoxil hydrobromide; formerly SPR994) is Spero’s novel late-stage development asset, an oral formulation of tebipenem pivoxil, a carbapenem antibiotic of the β-lactam class marketed by Meiji Seika Pharma Co. Ltd. (Meiji) in Japan as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinusitis. Carbapenems are an important subclass of antibiotics because they have been observed to be safe and effective in the treatment of drug-resistant Gram-negative bacterial infections. Tebipenem HBr is being developed for the treatment of cUTI, including acute pyelonephritis (AP), caused by certain bacteria. If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. The U.S. Food and Drug Administration (FDA) has granted tebipenem HBr Qualified Infectious Disease Product (QIDP) designation, for the treatment of cUTI, community-acquired pneumonia (CABP) and diabetic foot infections (DFI), and Fast Track designations for the treatment of cUTI and AP. Following feedback from the FDA at Spero’s recent Type A meeting, Spero will conduct an additional Phase 3 trial to support the potential approval of tebipenem HBr. Tebipenem HBr Research Support Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C. About SPR206 SPR206 is an IV-administered next generation polymyxin product candidate designed to act directly on Gram-negative bacterial infections through the molecule’s interactions with the bacterial outer membrane. In pre-clinical studies, SPR206 has demonstrated potent broad-spectrum activity against Gram-negative bacteria, including organisms identified by the Centers for Disease Control and Prevention and the World Health Organization as urgent and serious threats to human health. Spero has completed a first-in-human Phase 1 assessment of SPR206 in which the product candidate was generally well-tolerated and demonstrated no evidence of nephrotoxicity at anticipated therapeutic doses. A Phase 1 bronchoalveolar lavage (BAL) clinical trial assessing the penetration of SPR206 into the pulmonary compartment and a Phase 1 renal impairment clinical trial of SPR206 have been completed. SPR206 has been granted QIDP designation by the FDA for the treatment of cUTI and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). SPR206 Research Support SPR206 clinical trials have been supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH1910295. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. The U.S. Army Medical Research Acquisition Activity, 839 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. About Spero TherapeuticsSpero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments for serious bacterial infections, including MDR bacterial infections and rare diseases. Spero Therapeutics is developing SPR720 as a novel investigational oral candidate antimicrobial for the treatment of a rare, orphan pulmonary disease caused by infection with non-tuberculous mycobacteria (NTM-PD).Spero Therapeutics is developing SPR206 as an investigational IV-administered next-generation polymyxin product candidate developed from its potentiator platform, which is in development to treat MDR Gram-negative infections in the hospital setting.Tebipenem HBr is an investigational oral carbapenem candidate antimicrobial in development for the treatment of cUTI, including pyelonephritis, including infections caused by MDR pathogens in adult patients who have limited oral treatment options. For more information, visit https://sperotherapeutics.com. Forward Looking StatementsThis press release may contain forward-looking statements. These statements include, but are not limited to, statements about the future development and commercialization of SPR720, SPR206, and tebipenem HBr; and the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs. In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether tebipenem HBr will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; the lengthy, expensive, and uncertain process of clinical drug development for SPR720 and SPR206; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the U.S. Securities and Exchange Commission. The forward-looking statements included in this press release represent Spero’s views as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero’s views as of any date subsequent to the date of this press release. Investor Relations Contact: Ted JenkinsVice President, Investor Relations and Strategic FinanceIR@sperotherapeutics.com (617) 798-4039 Media Inquiries: Matt Dick, Health Media RelationsZeno Groupmatt.dick@zenogroup.com301-509-8532

NIAID Agreement to Advance Development of Epetraborole for Acute Systemic MelioidosisNon-dilutive funding will drive synergies with existing epetraborole development program for NTM lung diseaseAward leverages AN2 Therapeutics expertise and commitment to address urgent unmet global health needsWork could help address U.S. biothreat pathogen MENLO PARK, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the award of a contract valued up to $17.8 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance the development of epetraborole for acute systemic melioidosis. The base period contract is $4.3 million with additional options that, if exercised, will total $17.8 million to support preclinical, Phase 1 studies and other activities to enable advancement of epetraborole into a pivotal Phase 2/3 clinical trial for acute systemic melioidosis. AN2 Therapeutics is currently developing epetraborole in an ongoing pivotal Phase 2/3 trial for treatment refractory Mycobacterium avium complex (MAC) lung disease, the most common form of nontuberculous mycobacterial (NTM) lung disease. “Melioidosis, a disease caused by the bacteria Burkholderia pseudomallei, is predominately a disease of tropical climates, especially in South Asia and northern Australia where it is widespread. However, B. pseudomallei was recently found in the environment along the Gulf Coast in the United States,” said Eric Easom, Co-Founder, President and Chief Executive Officer. “Epetraborole has shown significant promise in non-clinical models of infection for melioidosis and could have the potential to reduce mortality in patients suffering from the disease. In addition to addressing an urgent unmet global health need, this work will aid in addressing a high priority biothreat pathogen and will allow us to capture synergies with our ongoing development of epetraborole for NTM. We are pleased to partner with the NIH on this meaningful global health work that is core to our corporate mission and values.” This project has been funded in whole with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93022C00059. About MelioidosisMelioidosis is an infectious disease caused by the bacterium B. pseudomallei. It is endemic to tropical regions of the world with the majority of cases occurring in South Asia and Northern Australia, and was recently found in the southern U.S. It is contracted from direct contact with contaminated soil and water and is not transmitted person-to-person. Similar to NTM, B. pseudomallei is an intra-cellular pathogen in macrophages. Infections can manifest as localized infections causing pain, swelling and ulceration; as pulmonary infections causing cough, chest pain, high fever, and headache; and as blood stream infections causing fever, headache, respiratory distress, and abdominal discomfort. Current treatment generally starts with an intense phase of intravenous antibiotic treatment for a minimum of two weeks. Even with antibiotic treatment, the mortality rate is between 20% and 40%. Without treatment, six out of ten people die. There are an estimated 165,000 cases of melioidosis globally each year. About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. AN2 is developing epetraborole, a once-daily, oral treatment with a novel mechanism of action for patients with NTM lung disease, a rare, chronic, and progressive infectious disease caused by bacteria, known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at www.an2therapeutics.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: AN2's anticipated progress, business plans, business strategy and planned clinical trials; AN2's Phase 2/3 pivotal clinical trial and the timing thereof; the potential clinical benefits and therapeutic potential of epetraborole; the timing of initial data from AN2's Phase 2/3 pivotal clinical trial; the ability of AN2’s Phase 2/3 pivotal clinical trial to support regulatory approval; and other statements that are not historical fact. These statements are based on AN2's current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include those described under the heading “Risk Factors” in AN2's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 filed with the U.S. Securities and Exchange Commission (SEC). These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. COMPANY CONTACT: Lucy O. Day Chief Financial Officer l.day@an2therapeutics.com INVESTOR AND MEDIA CONTACT:  Anne Bowdidge  ir@an2therapeutics.com