Sulfamethoxazole

ELIMINATE trial is evaluating LBP-EC01 for treating urinary tract infections caused by drug-resistant E. coli Funding to support advancement into Part 2 of ELIMINATE trial RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Locus Biosciences Inc. (“Locus”), a clinical-stage biotechnology company developing a new class of precision engineered bacteriophage treatments for a diverse set of bacterial diseases, today announced the release of $23.9 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to continue the development of Locus’ CRISPR-enhanced bacteriophage therapy, LBP-EC01, for treating urinary tract infections (UTIs) caused by drug-resistant Escherichia coli (E. coli) based on positive results from a Phase 2a clinical trial. Worldwide, an estimated 150 million people are affected by UTIs each year. Approximately 80% of these are caused by E. coli, often including difficult-to-treat strains that are resistant to commonly used antibiotics. Up to 40% of UTI patients experience a recurrence, often within months of the first episode. Both the U.S. Centers for Disease Control and Prevention and the World Health Organization have identified antibiotic-resistant E. coli as an urgent and serious public health threat requiring development of new treatments. “Engineered bacteriophage have emerged as one of the most promising technologies for addressing the worldwide public health crisis of multi-drug resistant (MDR) bacterial infections. While multiple small-scale studies have shown promise, the field urgently needs a definitive large-scale placebo-controlled study to conclusively test the efficacy of an engineered bacteriophage therapy,” said Paul Garofolo, Co-founder and CEO of Locus. “We are incredibly grateful for our partnership with BARDA in funding this clinical trial of a potential first-in-class precision medicine for an important unmet medical need.” The company’s recent successful completion of the uncontrolled open-label Part 1 portion of the two-part ELIMINATE Phase 2 trial triggered the release of this tranche of funding under its $85 million contract (75A50120C00169) with BARDA. The funding will be used to advance LBP-EC01 into the blinded, placebo-controlled, Part 2 of the ELIMINATE Phase 2 trial. In 2020, Locus and BARDA announced an agreement to co-fund development of LBP-EC01. Under the contract, BARDA will provide up to $85 million in funding to Locus as part of a $152 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration for LBP-EC01. The award announced today brings the amount released under the contract to $48.9 million. About the ELIMINATE Trial The two-part multicenter Phase 2 ELIMINATE trial is evaluating LBP-EC01 used concomitantly with trimethoprim/sulfamethoxazole (TMP/SMX) in adult female patients for the treatment of uncomplicated UTIs caused by drug resistant E. coli. The uncontrolled open-label Part 1 (dose-regimen selection) evaluated the safety, tolerability, pharmacokinetics and clinical and microbiologic outcomes of LBP-EC01 and TMP/SMX in 39 patients with uncomplicated UTI. Part 2 of the study has a primary objective of determining the efficacy of LBP-EC01 when used concomitantly with TMP/SMX, compared to control (placebo plus TMP/SMX), based on combined clinical and microbiological response of acute uUTI caused by drug resistant E. coli in up to 288 adult female patients. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50120C00169. For more information, visit clinicaltrials.gov using the identifier NCT05488340. Patients interested in participating in Part 2 of the Phase 2 trial can visit . About LBP-EC01 LBP-EC01 is a CRISPR-enhanced bacteriophage therapy in development for the treatment of urinary tract infections and other infections caused by the bacterial pathogen Escherichia coli (E. coli). It is a bacteriophage cocktail engineered with a CRISPR-Cas3 construct targeting the E. coli genome. The precision medicine product works through a unique dual mechanism of action utilizing both the natural lytic activity of the bacteriophage along with the DNA-targeting activity of CRISPR. LBP-EC01 previously met all primary and secondary endpoints and demonstrated safety and tolerability in a Phase 1b trial. LBP-EC01 is currently being evaluated in a Phase 2 trial for the treatment of UTIs caused by E. coli. About Locus Biosciences Locus Biosciences is creating a new class of precision biotherapeutics with clinical-stage engineered bacteriophage treatments for a diverse set of bacterial and microbiome/inflammatory diseases. A world-leading bacteriophage discovery, synthetic biology, and manufacturing platform powers the company. Locus engineers bacteriophage - naturally occurring viruses that target bacteria - to kill pathogenic bacteria, while sparing good bacteria, through programmable precision anti-bacterials with CRISPR-Cas3 and other therapeutic payloads. Its artificial intelligence and machine-learning based discovery engine targets bacteria that are associated with disease across therapeutic areas including infectious disease, immunology, and oncology. Locus has secured multiple non-dilutive partnerships to support development of the company’s platform and programs. These include contracts with Biomedical Advanced Research and Development Authority (BARDA) for Locus’ lead asset targeting E. coli and Combatting Antibiotic Resistant Bacteria Accelerator (CARB-X) for Locus’ asset targeting K. pneumoniae. For more on the Research Triangle Park, N.C.-based company, visit . Media Contact: Heather Anderson 6 Degrees handerson@6degreespr.com

Financing led by Petrichor strengthens VERO Biotech's position as a leader in neonatal intensive care ATLANTA, Jan. 11, 2023 /PRNewswire/ -- VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, today announced the successful close of a $30 million financing with Petrichor, a leading healthcare-dedicated growth capital provider. The proceeds will support further development and commercialization of VERO Biotech's GENOSYL Delivery System (DS), a tankless inhaled nitric oxide (iNO) delivery system. The third generation of the GENOSYL DS was recently approved by the FDA and represents a breakthrough in iNO technology benefitting both providers and patients. Patrick Lally, Partner of Petrichor, has joined the VERO Biotech Board of Directors. Details of the financing were not disclosed. Continue Reading "This funding represents our commitment to the continuous development of the GENOSYL Delivery System, as well as to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face," said Brent V. Furse, CEO and President, VERO Biotech. "We are grateful for the partnership with Petrichor, the confidence they have placed in VERO Biotech, and their recognition of our commercial success to date and strategies for further expansion." VERO Biotech Raises $30M to Accelerate Commercialization of Its Innovative Tankless Inhaled Nitric Oxide Delivery System Tweet this "VERO Biotech has rapidly established itself as a leader in neonatal intensive care through the commercial success of GENOSYL DS, with its tankless system representing the first innovation in the delivery of inhaled nitric oxide approved by the FDA in 20 years," commented Mr. Lally. "We have been impressed with VERO Biotech's commercial growth in addition to its commitment to continued innovation, evidenced by the recent FDA approval for its third-generation product design. The VERO Biotech team is dedicated to addressing the unmet needs of respiratory disease specialists who treat persistent pulmonary hypertension of the newborn, a serious condition in term or near-term newborns that affects 100,000 neonates each year. We look forward to supporting the VERO Biotech team in their pursuit of better neonatal patient care." About GENOSYL® Indication GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Important Safety Information GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure. Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours. Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration. In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema. The most common adverse reaction is hypotension. Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia. GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL. Please visit for the full Prescribing Information for GENOSYL. About GENOSYL® DS GENOSYL DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients with an easy-to-use interface and portability features. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. About VERO Biotech VERO Biotech Inc. is a privately held company headquartered in Atlanta, Georgia focused on saving lives, alleviating suffering, and improving health economics in the neonatal intensive care and the acute care hospital communities. About Petrichor Petrichor partners with world-class healthcare managers and businesses to provide customized investment structures and support. The Petrichor team has completed over 125 investments representing more than $6 billion in invested capital and has held over 50 board seats. Petrichor maintains a deep in-house understanding of healthcare products and services, including scientific, technical, and commercial expertise. This healthcare expertise, together with a breadth of experience investing across sectors, geographies, and capital structures, provides a unique combination to help build successful companies. For more information on Petrichor, please see or contact the firm at [email protected]. Forward Looking Statements This press release and any statements of representatives of VERO Biotech Inc. related thereto that are not historical in nature contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to VERO Biotech's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "seeks," "intends," "plans," "potential" or similar expressions, including statements with respect to the potential effects of its products and plans to assess and undertake next steps for VERO Biotech Inc. These statements are based upon the current beliefs and expectations of VERO Biotech's management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond the control of VERO Biotech). For information, please visit or contact Ray Russo at [email protected] or (908) 313-7172. Contact for VERO Biotech Ray Russo Head of Commercial Development Phone: +1 917-313-7172 Email: [email protected] Contact for Petrichor David Katona Head of Business Development and IR Phone: +1 646-443-6606 Email: [email protected] SOURCE VERO Biotech Inc.