Paratek Pharmaceuticals

MA - Boston

Pharmaceutical

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Focus: Small Molecules

Paratek Pharmaceuticals is a life sciences company focused on Small Molecules.

Neurology

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Products & Portfolio (3)

NUZYRA

omadacycline

Peak

SMINTRAVENOUS · POWDER

12.1 Mechanism of Action NUZYRA is an antibacterial drug [see ]. 12.2 Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically relevant QTc prolongation was observed at the maximum recommended dose of omadacycline. Cardiac Physiology-Increase in Heart Rate In phase 1 studies conducted in healthy volunteers, reversible dose-dependent increases in heart rate have been observed following administration of single and multiple doses of omadacycline. The clinical implication of this finding is unknown [see ]. In a standard radiolabeled ligand binding assays, omadacycline was shown to inhibit binding of H-scopolamine to the M2 subtype of the muscarinic acetylcholine receptor. In the heart, muscarinic M2 receptors serve as mediators of the parasympathetic input that normally is received via the vagus nerve and stimulation of the receptor increases membrane potassium conductance through the acetylcholine-dependent channel, which slows depolarization and reduces pacemaker activity in the sinoatrial node. 12.3 Pharmacokinetics The pharmacokinetic parameters of NUZYRA after single and multiple oral and intravenous doses are summarized in Table 6 . Table 6: Mean (SD) Pharmacokinetic Parameters of NUZYRA in Healthy Adult Subjects Dose and Route of Administration 100 mg IV 300 mg Oral 450 mg Oral C max = maximum plasma concentration, AUC = area under concentration-time curve, IV = intravenous, ND = not determined, T max = time to C max PK Parameters All PK parameters presented as mean (standard deviation), Number of Subjects, unless otherwise specified C max ng/mL Single dose 1507 (582) (n=63) 548 (146) (n=103) 874 (232) (n=24) Steady state 2116 (680) (n=41) 952 (420) (n=43) 1077 (269) (n=24) AUC h*ng/mL Single dose Presented as AUC (0-inf) 9358 (2072) (n=62) 9399 (2559) (n=102) 13504 (3634) (n=24) Steady state Presented as AUC (0-24) 12140 (3223) (n=41) 11156 (5010) (n=43) 13367 (3469) (n=24) Accumulation Accumulation ratio 1.5 Absorption Bioavailability 34.5% following single 300 mg dose of NUZYRA T max Median (min, max) Single dose 0.6 (0.3, 0.7) (n=63) 2.5 (1, 4.1) (n=103) 2.5 (1.5, 3) (n=24) Steady state 0.5 (0, 1) (n=41) 2.5 (0, 8) (n=43) 2.5 (1.5, 4) (n=24) Distribution Plasma Protein Binding 20%; not concentration dependent Volume of Distribution L Single dose 256 (66) (n=62) 794 Presented as apparent clearance or volume of distribution (188) (n=27) 914 (821.9) (n=23) Steady state 190 (53) (n=41) 440 (262) (n=34) 607 (197.4) (n=24) Elimination Elimination Half-Life h Single dose 16.4 (2.1) (n=62) 15.0 (2.5) (n=81) 13.45 (1.7) (n=23) Steady state 16.0 (3.5) (n=41) 15.5 (1.7) (n=21) 16.83 (1.4) (n=23) Systemic Clearance L/h Single dose 11.24 (2.7) (n=62) 34.6 (10.7) (n=27) 43.4 (49.8) (n=23) Steady state 8.8 (2.2) (n=41) 18.3 (8.3) (n=34) 21.2 (8.9) (n=24) Renal Clearance L/h 3.1 (0.69) (n=8)

Staphylococcus aureus (methicillin-susceptible isolates)Haemophilus influenzaeHaemophilus parainfluenzae+9 more

Staphylococcus aureus (methicillin-susceptible isolates)Haemophilus influenzaeHaemophilus parainfluenzae+9 more

2018

XHANCE

fluticasone propionate

Peak

NASAL · SPRAY, METERED

2017

Pipeline & Clinical Trials

Omadacycline

Community-acquired Pneumonia

Phase 1

Clinical Trials (1)

NCT04160260Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia

Phase 1

Omadacycline Injection [Nuzyra]

Bacterial Infections

Phase 1

Clinical Trials (1)

NCT05217537Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

Phase 1

Omadacycline

Healthy Volunteers

Phase 1

Clinical Trials (1)

NCT06030219Microbiome Effect of Omadacycline on Healthy Volunteers

Phase 1

Omadacycline

Diabetes

Phase 1

Clinical Trials (1)

NCT04144374Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Phase 1

Omadacycline Oral Tablet

Mycobacterium Infections, Nontuberculous

Phase 2

Clinical Trials (1)

NCT04922554Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc)

Phase 2

Omadacycline tablets

Uncomplicated Urinary Tract Infection

Phase 2

Clinical Trials (1)

NCT03425396Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis

Phase 2

Omadacycline

Acute Pyelonephritis

Phase 2

Clinical Trials (1)

NCT03757234IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

Phase 2

Omadacycline Pill

Bone Infection

Phase 2

Clinical Trials (1)

NCT05753215Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

Phase 2

PTK 0796

Infectious Skin Disease

Phase 2

Clinical Trials (1)

NCT03716024Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Phase 2

Omadacycline

Bacterial Pneumonia

Phase 3

Clinical Trials (1)

NCT02531438Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

Phase 3

Omadacycline

Bacterial Infections

Phase 3

Clinical Trials (1)

NCT02877927Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI

Phase 3

Omadacycline

Bacterial Infections

Phase 3

Clinical Trials (1)

NCT02378480Omadacycline Versus Linezolid for the Treatment of ABSSSI (EudraCT #2013-003644-23)

Phase 3

Omadacycline

Community-acquired Pneumonia

Phase 3

Clinical Trials (1)

NCT04779242Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Phase 3

PTK 0796

Skin Diseases, Infectious

Phase 3

PTK 0796

Skin Structures and Soft Tissue Infections

Phase 3

Clinical Trials (1)

NCT00876850Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

Phase 3

Omadacycline Injection

Microbial Colonization

Phase 4

Clinical Trials (1)

NCT05515562Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Phase 4

Omadacycline Injection [Nuzyra]

Cystic Fibrosis

Phase 4

Clinical Trials (1)

NCT04460586Pharmacokinetics of Omadacycline in Cystic Fibrosis

Phase 4

Open Jobs (24)

Interview Prep Quick Facts

Portfolio: 3 approved products, 17 clinical trials

Top TAs: Infectious Diseases, Respiratory

Open Roles: 24 active jobs

Portfolio Health

Peak3 (100%)

3 total products

Therapeutic Area Focus

Infectious Diseases

2 marketed6 pipeline

Respiratory

1 pipeline

Marketed

Pipeline

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Stable

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Based on last 4 crawl cycles

Paratek Pharmaceuticals

Products & Portfolio (3)

Pipeline & Clinical Trials

Open Jobs (24)

Specialty Sales Representative (San Francisco, CA)

Specialty Sales Representative (Bridgeport, CT)

Specialty Sales Representative (Akron, OH)

Specialty Sales Representative (Omaha, NE)

Specialty Sales Representative (Parsippany, NJ)

Specialty Sales Representative (Columbia, MO)

Specialty Sales Representative (Macon, GA)

Specialty Sales Representative (Chattanooga, TN)

Specialty Sales Representative (Wilmington, NC)

Specialty Sales Representative (Fort Wayne, IN)

Specialty Sales Representative (Ann Arbor, MI)

Regional Business Director (Northeast)

Specialty Sales Representative (Bloomington, IN)

Hospital Sales Representative (Seattle, Olympia and Portland)

Regional Business Director (West)

Specialty Sales Representative (Lakeland, FL)

Specialty Sales Representative (Charlottesville, VA)

Hospital Sales Representative (Washington DC)

Specialty Sales Representative (Grand Rapids, MI)

Specialty Sales Representative (Rocky Mount, NC)

Director, Marketing

Specialty Sales Representative (Phoenix N./Flagstaff, AZ)

Associate Director, Quality (QMS)

Senior Manager, Microsoft Cloud Infrastructure and End User Services Delivery

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