DALLAS, TEXAS – Mycobacterium abscessus lung disease (MALD) has long been regarded as one of the most challenging nontuberculous mycobacteria infections due to its resistance to commonly used antibiotics. In a groundbreaking study published in the "International Journal of Antimicrobial Agents," a consortium of esteemed physicians and scientists from multiple institutions has demonstrated the effectiveness of a new drug, omadacycline, for combating MALD.

The study, which was sponsored by the National Institute of Allergy and Infectious Diseases [NIAID], was published in the “International Journal of Antimicrobial Agents” May 09, 2023 doi: https://doi.org/10.1016/j.ijantimicag.2023.106847.

The research team, consisting of Drs. Shashikant Srivastava, Pamela J McShane, Julie V Philley from the University of Texas at Tyler School of Medicine, Dr. Scott K Hysell from the University of Virginia, and Drs. Jann-Yuan Wang and Hung-Ling Huang from National Taiwan University Hospital, along with pre-clinical Contract Research Organization Praedicare Inc., Dallas, Texas, led by Drs. Tawanda Gumbo and Jotam Pasipanodya, embarked on a series of preclinical and clinical studies to evaluate the efficacy of omadacycline in treating MALD.

Current treatments for MALD, including injectable drugs, are associated with high side effects and limited effectiveness in only 20-33% of patients. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), focused on investigating the potential of omadacycline as a viable solution.

Utilizing an innovative preclinical hollow fiber model system of MALD, the team conducted dose-effect studies to evaluate the effectiveness of omadacycline. The results from the hollow fiber model were then translated using advanced in silico tools to determine the optimal clinical dose capable of achieving a 90% cure rate in patients.

Additionally, a retrospective comparative-effectiveness study involving 19 patients was conducted to assess the efficacy of omadacycline in combination therapy. The findings revealed that omadacycline-combination regimens resulted in sustained sputum culture conversion rates of 80% in patients, surpassing the 33% achieved with all comparator combinations and the mere 11% achieved with tigecycline-combinations. Notably, patients treated with omadacycline reported no severe adverse events, in stark contrast to those treated with tigecycline.

Furthermore, a patient who had previously failed standard-of-care therapy followed by salvage therapy was prospectively recruited and treated with the omadacycline dose in combination therapy. After three months of omadacycline treatment, the patient achieved sustained sputum culture conversion without experiencing any adverse events. These compelling results provide crucial evidence supporting the inclusion of omadacycline in the treatment regimen for MALD.

"The pathway that starts with dose-effect studies in the hollow fiber model of MALD, followed by advanced in silico translation, accurately predicts the response rates to drugs achieved in patients," explained Dr. Gumbo. "This provides a valuable tool for testing new drug combinations for MALD," he added.

This groundbreaking research represents a significant milestone in MALD treatment and offers hope for patients struggling with this antibiotic-resistant nightmare. With the potential to revolutionize current therapeutic approaches, omadacycline shows promise as a vital addition to the treatment arsenal against MALD.

About Praedicare Inc.:

Praedicare Inc. is a pre-clinical Contract Research Organization based in Farmers Branch, Dallas, Texas. The organization specializes in conducting cutting-edge research and studies to advance medical knowledge and develop effective treatments for various infectious diseases.

About the University of Texas at Tyler School of Medicine:

The University of Texas at Tyler School of Medicine is a renowned medical institution committed to training exceptional physicians, conducting groundbreaking research, and providing high-quality patient care. With a focus on innovation and collaboration, the School of Medicine strives to significantly contribute to healthcare and medical advancements.

About the National Institute of Allergy and Infectious Diseases (NIAID):

The National Institute of Allergy and Infectious Diseases (NIAID) is a leading research organization dedicated to understanding, preventing, and treating infectious and immunological diseases. NIAID supports and conducts cutting-edge research to address critical health challenges, fostering the development of innovative approaches to combat infectious diseases.

For more information about Praedicare Inc., the University of Texas at Tyler School of Medicine, or the National Institute of Allergy and Infectious Diseases (NIAID), or further details regarding this news release, please contact:

Contacts

Danielle Meyer
214-954-7671
Danielle.meyer@praedicareinc.com