Paratek Pharmaceuticals Announces the Publication of Data from an Investigator-Initiated Study of NUZYRA® (omadacycline) in a Hollow Fiber System Model Against Pulmonary Mycobacterium avium complex

Rhea-AI Summary

Paratek Pharmaceuticals has announced positive results from an investigator-initiated study showcasing the efficacy of NUZYRA® (omadacycline) against Mycobacterium avium complex (MAC) pulmonary infections. Conducted by Chapagain et al., the study found NUZYRA demonstrated considerable potency at standard clinical doses, suggesting it could serve as a viable treatment option against MAC infections. The company plans to conduct further research to validate these findings. Additionally, Paratek is advancing a Phase 2b study of NUZYRA for NTM pulmonary disease, estimating a potential $1 billion market in the U.S.

Positive

• NUZYRA demonstrated significant efficacy against MAC in a hollow fiber infection model.
• Study results support potential further research for NUZYRA in treating pulmonary NTM infections, addressing a critical unmet medical need.
• Paratek is conducting a Phase 2b study of NUZYRA in a rare disease, targeting an estimated $1 billion market opportunity.

Negative

• Mortality imbalance observed in prior CABP clinical trials raises safety concerns.
• Limited patient population could delay enrollment in ongoing studies.

BOSTON, March 08, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. announced today the publication of data from an investigator-initiated study evaluating the activity of NUZYRA® (omadacycline) in a dynamic hollow fiber model of Mycobacterium avium complex (MAC) pulmonary infection.  

The investigator-initiated study conducted by Chapagain et al. entitled “Omadacycline efficacy in the hollow fibre system model of pulmonary Mycobacterium avium complex and potency at clinically attainable doses” was supported by a research grant from Paratek and published in the Journal of Antimicrobial Chemotherapy.

The authors determined that NUZYRA demonstrated considerable efficacy and potency against MAC when tested in a hollow fiber system infection model at the standard clinical doses approved for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults. Subsequent simulations conducted to identify the optimal dose of oral omadacycline predicted that standard clinical doses would be bactericidal in the treatment of pulmonary MAC.

“In this study, we confirmed our hypothesis that NUZYRA, because of its known spectrum of activity, would demonstrate activity against MAC in this infection model,” said investigator Tawanda Gumbo, M.D., chief executive officer of Praedicare, Inc. “Based on the impressive results showing the highest NUZYRA exposure produced a similar reduction in mycobacterial burden as a three-drug standard of care regimen consisting of clarithromycin plus rifabutin and ethambutol, we believe further research is warranted to determine the potential of NUZYRA as a treatment option for pulmonary NTM infections caused by MAC.” 

“Efficacy and tolerability challenges associated with certain existing standard of care drugs used to treat pulmonary MAC infections further highlight the need for the development of novel antibiotic treatments for the estimated 100,000 cases of NTM pulmonary disease caused by MAC in the United States alone,” added Randy Brenner, chief development and regulatory officer of Paratek. “We are encouraged by the findings of this study and plan to conduct further nonclinical research evaluating NUZYRA alone or in combination with standard of care antibiotics used to treat pulmonary MAC.” 

Paratek is also conducting a Phase 2b study of NUZYRA in NTM pulmonary disease caused by Mycobacterium abscessus complex. This U.S.-based, placebo-controlled, randomized monotherapy study will enroll approximately 75 patients. Paratek expects to complete enrollment in late 2023 due to the small numbers of patients with this rare disease.

About Paratek Pharmaceuticals, Inc. 
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.  

The company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. 

Paratek is also conducting a Phase 2b study of NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.  

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. 

In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), now valued at up to approximately $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax. 

For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. 

About NUZYRA 
NUZYRA^® (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. 

Indications and Usage 
NUZYRA is a tetracycline-class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: 

Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae. 

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae and Klebsiella pneumoniae.  

Usage 
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 

Important Safety Information 

Contraindications 
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients. 

Warnings and Precautions 
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. 

The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. 

The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth. 

Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. 

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. 

NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. 

Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 

Adverse Reactions 
The most common adverse reactions (incidence=2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia and constipation. 

Drug Interactions 
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. 

Use in Specific Populations 
Lactation: Breastfeeding is not recommended during treatment with NUZYRA. 

To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Please see full Prescribing Information for NUZYRA at www.NUZYRA.com. 

Forward Looking Statements 
This press release contains forward-looking statements including statements related to the efficacy and potent activity of NUZYRA against slow-growing mycobacteria, including MAC, that future study is warranted for NUZYRA as a component of multidrug treatment regimens for pulmonary NTM infections caused by MAC, in our clinical studies for NTM and the potential for NUZYRA to fill an unmet medical need for NTM patients.

All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as "advancing," "expect," "look forward," "anticipate," "continue," and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein. 


CONTACT: 

For Investors:  
Hans Vitzthum 
LifeSci Advisors 
ir@ParatekPharma.com 
Phone: 617 430 7578 

For Media: 
Christine Fanelle 
Scient PR 
Christine@scientpr.com 
Phone: 215 595 5211 

FAQ

What were the findings of the recent study on NUZYRA (PRTK) related to MAC infections?

The study found that NUZYRA exhibited significant efficacy and potency against Mycobacterium avium complex when tested at standard clinical doses.

What is Paratek Pharmaceuticals planning after the study of NUZYRA for MAC?

Paratek plans to conduct further research to evaluate NUZYRA's potential as a treatment option for pulmonary NTM infections caused by MAC.

What is the market potential for NUZYRA in the treatment of pulmonary diseases?

Paratek estimates that the opportunity for NUZYRA in treating NTM pulmonary disease represents a potential $1 billion addressable market in the U.S.

What safety concerns were raised in the press release regarding NUZYRA (PRTK)?

The press release noted a mortality imbalance observed during CABP trials with NUZYRA, indicating the need for careful monitoring in patients.