Antibiotics in the clinical pipeline as of December 2022 | The Journal ...

Clinical Infectious Disease

Editor

David Schlossberg, Temple University, PhiladelphiaDavid Schlossberg is Professor of Medicine, Temple University School of Medicine, Adjunct Professor of Medicine, University of Pennsylvania School of Medicine, and Medical Director, Tuberculosis Control Program, Philadelphia Department of Public Health, Philadelphia, PA, USA.

Contributors

Cheston B. Cunha, Burke A. Cunha, Joseph Adrian L. Buensalido, Rodger D. MacArthur, N. Cary Engleberg, Itzhak Brook, Jeanne Carey, Stephen G. Baum, Stephen I. Pelton, Charles D. Bluestone, Todd D. Otteson, Bridget Hathaway, Jennifer Rubin Grandis, Jonas T. Johnson, Zainab Alhamal, Mary Jordan, Issam Raad, Jeremy D. Gradon, Elmer Y. Tu, Francis S. Mah, Jules Baum, Alice Lorch, Daniel M. Albert, Amol D. Kulkarni, Amir A. Azari, Roy D. Brod, Harry W. Flynn, Jr, Lili Grunwald, Marlene L. Durand, John W. Sensakovic, Leon G. Smith, Aristides P. Assimacopoulos, Wilmara Salgado-Pabón, Patrick M. Schlievert, Lisa M. Chirch, Kevin D. Dieckhaus, Jane M. Grant-Kels, Joanne T. Maffei, Alok Vij, Kenneth J. Tomecki, Stephen Ash, Louis Kennedy, Ellie J. C. Goldstein, Fredrick M. Abrahamian, Gentiane Monsel, Olivier Chosidow, Tania F. Cestari, Simone Pessato, Gian L. Vinelli, Evelyn K. Koestenblatt, Jeffrey M. Weinberg, Ncoza C. Dlova, Anisa Mosam, Antoinette Chateau, Sheela Shenoi, Gerald Friedland, Phillippa Poole, Mark Hobbs, Irmgard Behlau, Thomas M. File, Jr, Keyur S. Vyas, Suttirak Chaiwongkarjohn, Arash Heidari, Christopher Graber, Matthew Bidwell Goetz, Lisa L. Dever, Charlotte E. Bolton, Dennis J. Shale, Mashiul H. Chowdhury, Amanda M. Michael, Richard A. Martinello, Michael Cappello, Lori Blauwet, Ravi Karra, Keith S. Kaye, Susan E. Beekmann, David K. Henderson, M. Rizwan Sohail, James M. Steckelberg, Kalyan Ram Bhamidimarri, Paul Martin, Michelle E. Freshman, Lawrence S. Friedman, Anton R. Fried, Robert V. Rege, Patricia Wong, H. Franklin Herlong, Jodie A. Barkin, Jamie S. Barkin, Mark Flasar, Jean-Pierre Raufman, Douglas R. Morgan, Vivian Chidi, Robert L. Owen, Carly R. Davis, Andrew T. Pavia, John G. Bartlett, Thomas C. Quinn, Bian Wu, John Maa, Ronald L. Nichols, James R. Korndorffer, K. Shad Pharaon, Donald D. Trunkey, Ross M. Clark, Thomas R. Howdieshell, Linda A. Slavoski, Matthew E. Levison, Amirkaveh Mojtahed, Payam Afshar, George Pappas, Ioannis A. Bliziotis, Matthew E. Falagas, Sebastian Faro, Suyin Chi, Thomas Fekete, Allan Ronald, Jonathan M. Zenilman, William J. Ledger, Keith W. Hamilton, Judith A. O'Donnell, Jack D. Sobel, David B. Banach, Louise M. Dembry, Shahbaz Hasan, James W. Smith, Richard H. Parker, Ilona Kronig, Pierre Vaudaux, Domizio Suvà, Daniel Lew, Ilker Uçkay, Kathryn H. Dao, John J. Cush, Elizabeth Soda, Upinder Singh, Lisa M. Kodadek, Pamela A. Lipsett, Sarbjit Sandu, Allan R. Tunkel, Burt R. Meyers, Dalilah Restrepo, David N. Irani, Brian Wispelwey, Scott K. Heysell, Mark J. DiNubile, Jeffrey M. Percak, Rodrigo Hasbun, Debra Weiner, Joshua J. Chalkley, Joseph R. Berger, Elisabeth E. Adderson, Patricia M. Flynn, Richard T. Johnson, Thomas A. Fleisher, Eric Sachinwalla, Rafik Samuel, Amar Safdar, Donald Armstrong, Babafemi O. Taiwo, Robert L. Murphy, Pritha Sen, Jatin M. Vyas, Raymund R. Razonable, Stefan Bughi, Sylvia J. Shaw, Carlo Contoreggi, Laurel C. Preheim, Mir Akbar Ali, Kent Crossley, Patrick G. Gallagher, Robert S. Baltimore, Raul E. Isturiz, Jorge Murillo, Peter Mariuz, Roy T. Steigbigel, Larry I. Lutwick, Fouad Bouharb, Aaron E. Glatt, Kathleen Squires, Christopher T. Miller, Suzaan Marais, Graeme Meintjes, Anthony Ogedegbe, Marshall J. Glesby, Jeffrey Jacobson, Gonzalo Bearman, Karen Beydoun, David T. Kuhar, Susan K. Seo, Arthur E. Brown, William R. Jarvis, Virginia R. Roth, Anne-Marie Chaftari, Issam Raad, Lindsay E. Nicolle, E. Patchen Dellinger, Mark A. Malangoni, Gordon Dickinson, John Oeltjen, Roger W. Yurt, Rafael Gerardo Magaña, James P. Steinberg, Nadine G. Rouphael, Joseph S. Solomkin, Giorgio Tarchini, Elaine C. Jong, Alimuddin Zumla, David J. Weber, Jonathan J. Juliano, William A. Rutala, Steven C. Buckingham, Andrea K. Boggild, Mary Elizabeth Wilson, Karen J. Vigil, Herbert L. DuPont, Andrew W. Artenstein, Thomas A. Russo, Rajinder P. S. Bajwa, Sydney M. Finegold, Tirdad Zangeneh, Marc Traeger, Stephe

INSIDE LOOK: Infectious Disease Researchers Training With Animal Models At K-State Lab

TOPEKA (KSNT)- Kansas researchers are in the next phase of getting ready to study infectious diseases. The National Bio Agro-defense Facility (NBAF) is partnering with Kansas State University, so researchers can get hands-on experience at the university's clinical skills lab.

"They simulate the environment that individuals will be working in, but they focus on skill building, so that when they've moved to the testing, they've mastered those skills," said Dr. Elizabeth Davis, Associate Dean of Clinical Programs at K-State's College of Veterinary Medicine.

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The training partnership started in 2021, at a time when, Davis said, it was hard to get everyone in the lab during the pandemic. Now, researchers are able to work with a wide selection of animal models.

Susan Rose, a Clinical Education Technician at K-State's lab, said that working with animals to research infectious diseases requires a unique level of training.

"How to handle things, like how do you hold a syringe and use it with one hand, and what's the other hand doing, and how's my body and what's the angle like, so there's all sorts of fine tuning to the body for every skill that they teach," Rose said.

The lab's animal models range from goats and sheep to horses and cattle.

New animal models have also been constructed based on what NBAF's researchers will be studying.

"What NBAF offered to the clinical skills lab were different models than what the vet students were normally part of their core curriculum. So, we brought in our mimic-y mice, you know, mice are a typical lab animal. We talked about doing some work with swine," Dr. Maggie Behnke, NBAF Attending Veterinarian, said.

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Ten NBAF animal care team technicians and veterinary scientists will be training at the lab. It offers everything from simple models to ones with artificial veins, so researchers can learn to draw blood for testing.

Rose demonstrated how researchers are learning to interact with different animals when drawing blood samples.

"When you're working with pigs for the first time, you don't realize how loud they are, so having that distraction suddenly while you're trying to take a blood sample, is part of the simulation to try to make it more realistic, like 'Wow that's really loud!'" she said.

"We really emphasize what do you do, so you're not potentially going to stick yourself with that needle, and expose yourself to pathogens or just infection," Rose explained.

Once researchers get to the live-animal phase, they will be transitioning over to NBAF's lab, which is expected to be fully operational in late 2024.

View the latest headlines from Kansas City, Missouri, and Kansas at fox4kc.Com

There, they will be studying everything from diseases threatening the nation's livestock to some of the most dangerous animal-borne diseases with no cure.

"The more practice that we can have, the more confidence our staff will feel. The safer they will be when we actually start doing work," Behnke said.

For the latest news, weather, sports, and streaming video, head to FOX 4 Kansas City WDAF-TVNews, Weather, Sports.

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Matinas BioPharma Announces Publication Of Results From The Phase 2 EnACT Clinical Trial Of MAT2203 In The IDSA Journal Clinical Infectious Diseases

BEDMINSTER, N.J., Aug. 22, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, announces that University of Minnesota Medical School researchers published results from the Phase 2 EnACT trial evaluating MAT2203 for the treatment of cryptococcal meningitis as a Major Article and Editor's Choice in Clinical Infectious Diseases, an official publication of the Infectious Diseases Society of America (IDSA). MAT2203 is an oral and non-toxic, LNC formulation of the potent antifungal drug amphotericin B.

David Boulware, MD, MPH, the senior investigator of the EnACT trial and infectious disease physician at the University of Minnesota, commented, "An orally administered amphotericin that is broad spectrum and non-toxic sounds like the holy grail of antifungal medicines. While further clinical trials are needed in other fungal conditions, the EnACT trial establishes proof of concept for the safe and effective treatment of invasive fungal infections. In this randomized trial of 141 HIV-positive individuals afflicted by life-threatening cryptococcal meningitis, the oral amphotericin MAT2203 product combined with oral flucytosine appears promising for cryptococcal meningitis with antifungal activity, similar survival, and less toxicity than intravenous amphotericin B. With six weeks of LNC-enabled oral amphotericin B, statistically fewer lab abnormalities occurred than with one week of intravenous amphotericin B."

"We are very pleased that the important EnACT data are being shared with the clinical and scientific community at large through publication in this peer-reviewed journal," said Theresa Matkovits, Ph.D., and Chief Development Officer of Matinas. "The results from EnACT in cryptococcal meningitis and our experience with patients enrolled in our Compassionate/Expanded Use Access Program support our belief that MAT2203 has the potential to become an important part of the regimen for treatment of invasive fungal infections, including in the highest-need patients who require longer-term treatment and have limited or no treatment options. The publication of the EnACT data in Clinical Infectious Diseases is yet another milestone for our development program. We would like to thank all the EnACT participants, our dedicated investigators, and the entire clinical study team in Uganda for their commitment to this important clinical trial."

About the EnACT Phase 2 Study

EnACT was a Phase 2 prospective, randomized, open-label, sequential cohort study, financially supported by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH), evaluating the safety, tolerability, and efficacy of MAT2203 in 100 HIV-positive persons with cryptococcal meningitis compared to 41 persons randomized to receive standard of care intravenous amphotericin B.

The EnACT trial included a total of four cohorts of participants, with the first two cohorts testing MAT2203 as early step-down therapy following initial treatment with IV amphotericin B during the induction period, and the second two cohorts testing MAT2203 as potentially all oral therapy. Cohorts 1 and 3 were safety lead-ins to Cohorts 2 and 4, respectively. The induction period for all patients in each cohort (active or control) was 14 days, followed by an additional four weeks of treatment (active or control) during a consolidation/maintenance period.

About Clinical Infectious Diseases (CID)

Clinical Infectious Diseases (CID) is a leading journal in the field of infectious disease with a broad international readership. The Journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America and is among the most highly cited journals in the field of infectious diseases.

About Matinas BioPharma

Matinas BioPharma is a biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology.

Matinas' lead LNC-based therapy is MAT2203, an oral formulation of the broad-spectrum antifungal drug amphotericin B, which although highly potent, can be associated with significant toxicity. Matinas' LNC platform provides oral delivery of amphotericin B without the significant nephrotoxicity otherwise associated with IV-delivered formulations. MAT2203 also allows for safe, longer-term use outside of a hospital setting, which could have substantial favorable pharmacoeconomic impact. MAT2203 successfully completed the Phase 2 EnACT program in cryptococcal meningitis, meeting its primary endpoint and achieving robust survival. MAT2203 is being positioned for a single pivotal Phase 3 study in the treatment of aspergillosis and other invasive fungal infections, including mucormycosis, Candida auris and other candidiasis, and certain endemic fungal infections in persons with limited treatment options who are unable to be treated with azoles or echinocandins for reasons related to drug-drug interactions, resistance or for whom these antifungal agents are unable to be used for other clinical reasons.

In addition to MAT2203, preclinical and clinical data have demonstrated that this novel technology can provide solutions to many of the challenges standing in the way of achieving safe and effective intracellular delivery of both small molecules and larger, more complex molecular cargos such as RNAi, antisense oligonucleotides, and vaccines. The combination of its unique mechanism of action and flexibility with routes of administration (including oral) positions Matinas' LNC technology to potentially become a preferred next-generation intracellular drug delivery platform. For more information, please visit www.Matinasbiopharma.Com.

Forward-looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to our business activities, our strategy and plans, our collaboration with National Resilience, Inc., the potential of our LNC platform and PS-NP delivery technologies, and the future development of its product candidates, including MAT2203, the Company's ability to identify and pursue development, licensing and partnership opportunities for its products, including MAT2203, or platform delivery technologies on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to continue as a going concern, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.

Investor Contact:

LHA Investor RelationsJody CainJcain@lhai.Com310-691-7100

 

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