Paratek Pharmaceuticals Announces Enrollment of First Patient in Phase 2b Study Evaluating NUZYRA® (omadacycline) for Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)

Rhea-AI Summary

Paratek Pharmaceuticals (PRTK) has commenced a Phase 2b study to assess the safety and efficacy of NUZYRA (omadacycline) for treating nontuberculous mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex. This condition currently lacks FDA-approved treatments, affecting approximately 11,500 patients in the U.S. The study aims to enroll around 75 patients over two years, focusing on symptom improvement and safety. Paratek estimates this opportunity represents a potential $1 billion market in the U.S.

Positive

• Initiated Phase 2b study for NUZYRA targeting a significant unmet medical need.
• Potential addressable market opportunity of $1 billion in the U.S.

Negative

• No FDA-approved therapies currently available for the targeted condition.
• Mortality imbalance observed in previous CABP clinical trials raises safety concerns.

-- Potential $1 Billion Addressable Market Opportunity in the United States

BOSTON, Oct. 18, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the first patient has been enrolled in the company’s Phase 2b study evaluating the safety and efficacy of NUZYRA^® (omadacycline) for the treatment for nontuberculous mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex (MABc), a rare disease for which there is no FDA-approved therapy.

“We are excited to have initiated patient enrollment in this important study. We look forward to the trial producing important data that will further inform the potential of NUZYRA for the treatment of Mycobacterium abscessus complex with pulmonary disease. The study builds on the growing body of real-world evidence for NUZYRA,” said Randy Brenner, chief development and regulatory officer of Paratek. “We believe NUZYRA, a once-daily, oral, broad-spectrum antibiotic, has the potential to address important unmet medical needs for patients with this rare disease.”

Pulmonary infections caused by MABc affect approximately 11,500 patients in the United States. Patients have a myriad of symptoms including severe fatigue, fever, cough and shortness of breath. The standard of care typically involves a combination of multiple antibiotics not approved for this disease, which can often be life-long in duration and complicated by long-term tolerability challenges and multiple adverse events.

“NTM lung disease due to Mycobacterium abscessus can be a debilitating condition which can potentially lead to fatal respiratory failure. People with existing lung conditions are particularly susceptible,” said Kevin Winthrop, M.D., M.P.H., professor of infectious diseases, Oregon Health & Science University, and principal investigator. “This disease is notoriously resistant to most antibiotics and is very challenging to treat. There are currently no FDA-approved therapies for Mycobacterium abscessus, and I am encouraged that there is the potential for a new oral treatment on the horizon for these patients.”

About the Study
The Phase 2b study is a placebo-controlled, randomized monotherapy study of Mycobacterium abscessus pulmonary disease in patients who are not receiving other treatments. The U.S.-based study will enroll approximately 75 subjects, randomized in a 1.5 to 1 ratio. The primary study endpoints are improvement in symptoms and safety and tolerability following 12 weeks of treatment. Due to the small numbers of patients with this rare disease, Paratek expects the study will take about two years to complete enrollment.

More information can be found at clinicaltrials.gov under the study ID number NCT04922554.

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 in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA. 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 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 is the purpose of Paratek's Phase 2b study for NUZYRA?

The Phase 2b study aims to evaluate the safety and efficacy of NUZYRA for treating nontuberculous mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.

How many patients will be enrolled in the NUZYRA study?

Approximately 75 patients will be enrolled in the Phase 2b study.

What is the estimated market opportunity for NUZYRA in the U.S.?

Paratek estimates a potential $1 billion addressable market in the United States for NUZYRA.

What are the primary endpoints of the NUZYRA study?

The primary study endpoints include improvement in symptoms and the assessment of safety and tolerability following 12 weeks of treatment.

Why is the NTM pulmonary disease significant?

Nontuberculous mycobacterial pulmonary disease is significant because it currently has no FDA-approved treatments and can lead to severe symptoms and complications.