Omadacycline

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Pino’s lead antibiotic, omadacycline is the first antibiotic in a new class of compounds, aminomethylcyclines, that are related to the tetracyclines.

Omadacycline is an antibiotic in a new class of compounds, aminomethylcyclines, that are related to the tetracycline class.  Launched in the 1950s, the tolerability and efficacy of tetracyclines led to their extensive usage for the treatment of skin, respiratory and other infections.  However, increasing antibiotic resistance to tetracyclines has made them much less effective and limited their current usage to only a few types of infections. 

Omadacycline is a unique antibiotic designed specifically to overcome both the efflux and ribosomal protection mechanisms to tetracycline resistance.  Pino applied the principles of medicinal chemistry and the knowledge and experience of its chemists and biologists to design a molecule that overcomes tetracycline resistance mechanisms by substituting at the 7- and 9-positions on the tetracycline chemical structure. 

In June 2016 Pino announced positive efficacy data in a Phase 3 registration study in ABSSSI demonstrating the efficacy and safety of omadacycline compared to linezolid.

 

 Omadacycline is being developed as a once-daily, broad spectrum antibiotic with IV and oral formulations for use as empiric monotherapy in patients suffering from serious community-acquired bacterial infections particularly when antibiotic resistance is of concern.  The majority of hospitalizations due to community acquired infections are driven by diseases such as acute bacterial skin and skin structure infections (ABSSSI), community acquired bacterial pneumonia (CABP) and urinary tract infections (UTI).

 Omadacycline has broad spectrum activity for gram-positive, gram-negative, aerobes, anaerobes and atypical bacteria.  In vitro and In vivo studies have shown omadacycline has activity against drug resistant pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant and multi-drug resistant Stretococcus pneumoniae (PRSP and MDRSP), vancomycin-resistant Enterococcus species (VRE) and extended spectrum β-lactamase producing enterobacteriaceae (ESBL).

In June 2016 Pino announced positive efficacy data in a Phase 3 registration study in ABSSSI known as OASIS (Omadacycline in Acute Skin and skin structure Infections Study) demonstrating the efficacy and safety of omadacycline compared to linezolid.

In April 2017 Pino announced positive top-line results from a global, pivotal Phase 3 clinical study known as OPTIC (Omadacycline for Pneumonia Treatment In the Community) comparing its once-daily oral and IV, broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). 

This study represents the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 

Please find the full slide deck from the 4/3/17 investor webcast and teleconference here>>.

An oral-only Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016.  Study enrollment was completed in May 2017 and top line data are expected in mid-July 2017. 

A Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data were reported in November 2016.  The company plans to begin enrolling patients in a proof-of-concept Phase 2 study in complicated UTI as early as the fourth quarter of 2017.

 

Pino has reached agreement with the FDA under a Special Protocol Assessment (SPA) whereby if both the Phase 3 ABSSSI and CABP studies are positive, the Company would seek approval for both indications.  Omadacycline has been granted Fast Track status by the FDA.  In addition, Omadacycline has qualified infectious disease product (QIDP) status under the Generating Antibiotic Incentives Now (GAIN) act, which provides five additional years of market exclusivity beyond existing patent protections.

Pino has evaluated Omadacycline in more than 1,500 subjects in the clinical program.

Pino believes that there is an unmet need for a well-tolerated, broad-spectrum agent with IV and oral formulations that can be used in the empiric treatment of community acquired infections.   The Value Proposition of an broad-spectrum antibiotic with IV and oral formulations is that it can allow patients to “go home” and “stay home”.  For the in-patient, hospitalized patient – the ability to transition from the IV to a bioequivalent oral can potentially allow the patient to be discharged early and “go home”.  In the outpatient setting, there is the potential to start the patient on oral therapy and avoid a hospitalization altogether and “stay home”.  Oral treatments at home reduce the inherent risks associated with IV therapy and are more convenient for the patient. In addition, being able to facilitate early discharge or in some cases avoid hospitalization completely, provides a significant cost saving to payers. 

Pino owns world-wide rights to omadacycline.  Pino is open to discussing partnerships for ex-US rights with interested parties.  Please contact us here.