Baxdela: A Differentiated Phase 3 Asset
|PRODUCT/INDICATION||PRE CLINICAL||PHASE 1||PHASE 2||PHASE 3|
|Hospital-Treated Skin Infections (ABSSSI)
IV STUDY COMPLETED (SPA) (QIDP)
|NDA submitted Oct 2016|
|Hospital-Treated Skin Infections (ABSSSI)
IV-ORAL STUDY COMPLETED (SPA) (QIDP)
|NDA submitted Oct 2016|
|Hospital-Treated Community-Acquired Bacterial Pneumonia (hCABP)
|Hospital-Treated Complicated Urinary Tract Infections (cUTI)
IV-ORAL (PURSUING QIDP)
- ABSSSI: Acute bacterial skin and skin structure infections || hCABP: Hospital-treated community-acquired bacterial pneumonia || cUTI: Complicated urinary tract infections
QIDP: Qualified Infectious Disease Product || SPA: Special Protocol Assessment
Our lead candidate, Baxdela (delafloxacin), is an experimental drug candidate currently in clinical development belonging to the well-established quinolone class of antibiotics, which are currently used in one out of three hospital-treated infections. Baxdela has a highly differentiated and attractive profile. It has enhanced antimicrobial activity, including activity against MRSA (methicillin-resistant Staphylococcus aureus), a major cause of serious skin infections, a favorable tolerability profile, and convenient administration with both intravenous and oral forms. These features can provide economic value by lowering overall healthcare costs.
- Baxdela provides potent coverage of key bacterial pathogens. Baxdela is highly active against the broad groups of disease-causing bacteria – gram-positives, gram-negatives, atypicals and anaerobes. When presented with a patient with a serious infection, physicians are generally unable to immediately discern the causative bacteria, since different bacteria may present with a similar clinical syndrome. Thus, physicians may need to prescribe an antibiotic regimen that adequately covers the potential causative pathogens to rapidly achieve an effective response. The treatment choice must also consider the ever-evolving challenge of antibiotic-resistant bacteria. Given the limitations of diagnostic tools and the speed with which a physician needs to respond, Baxdela may significantly simplify the physician’s treatment decision.
- Baxdela has a favorable tolerability profile. A patient’s best chance of overcoming a bacterial infection occurs by taking an uninterrupted course of antibiotics. Many currently available antibiotics have serious side effects and tolerability issues that lead to early discontinuation or interruptions of treatment. Baxdela’s tolerability profile has been studied in more than 2,000 individuals in clinical trials to date. The most frequent adverse effects associated with Baxdela reported in studies have been diarrhea and nausea, mostly mild and self-limited in nature. Baxdela has demonstrated lower discontinuation rates versus the standard of care in its recently completed Phase 3 clinical trial in hospital-treated skin infections. In addition, Baxdela has not shown an adverse effect on heart rhythm or been shown to cause skin reactions to sunlight, which limit the utility of some other quinolones.
- Baxdela provides convenient intravenous and oral administration. The availability of both intravenous and oral dosing forms may potentially facilitate earlier hospital discharge, an important factor in reducing the possibility of patients acquiring new infections or spreading existing infections while in the hospital. The intravenous and oral formulations of Baxdela provide similar drug exposure in a fixed-dose regimen, eliminating the need for drug monitoring and dose titration, simplifying therapy administration for patients, physicians, and hospital staff.
- Baxdela may provide economic value. Physicians and hospitals are under increasing pressure to improve patient quality of care while reducing the total cost of care. When treating a bacterial infection, physicians must make immediate decisions on the choice of therapy that offers the highest chance of cure, requires the least administration burden on hospital resources while also considering the potential risk and associated cost of treatment side effects, extended hospitalization and hospital readmission. Baxdela, by virtue of its broad coverage of key pathogens, favorable safety and tolerability profile and convenient administration, may offer savings in hospital-treated skin infections based on preliminary third-party economic modeling. These saving may result from potential reductions in the length of hospitalization, costs of treating side effects, hospital staff burden, drug utilization, and lower rates of hospital readmission.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Baxdela has recently completed two Phase 3 studies, together known as PROCEED, for the treatment of patients with hospital-treated skin infections, also known as acute bacterial skin and skin structure infections (ABSSSI) caused by a variety of bacteria, including MRSA
Results from both Phase 3 PROCEED studies (study RX-3341-302, NCT01811732 and RX-3341-303, NCT01984684) to evaluate Baxdela versus vancomycin + aztreonam for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) showed that Baxdela met the study’s primary endpoint, demonstrating similarity (non-inferiority) in reducing lesion size at the primary infection site at 48-to-72 hours, the endpoint required by the U.S. Food and Drug Administration. Baxdela also was comparable to vancomycin in the study’s secondary endpoints, including investigator assessment of signs and symptoms of infection at the follow-up visit, a metric required by the European Medicines Agency (EMA). In these studies, Baxdela was shown to be well tolerated among study participants. Diarrhea and nausea were the most frequent treatment-related adverse events reported for Baxdela, and did not lead to study discontinuation.
In the second Phase 3 PROCEED study, RX-3341-303, Baxdela was tested as an intravenous (IV)-to-oral monotherapy regimen. Having IV and oral dosage forms may provide the potential for seamless and earlier hospital discharge, an important clinical and economic benefit.
Melinta submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela in October 2016.
In laboratory studies, Baxdela demonstrates broad antimicrobial activity, including activity against MRSA. MRSA is a particularly prominent pathogen in patients with serious skin infections. In a Phase 2 clinical trial exploring the safety and efficacy of Baxdela in ABSSSI, Baxdela demonstrated promising results in clinical cure rates (complete resolution of signs and symptoms) and lesion responses, and a favorable tolerability profile.
In January 2015, Melinta and Eurofarma Laboratórios entered into an agreement for the development and commercialization of Baxdela in Brazil for the treatment of ABSSSI. Subsequently, in March 2017, Melinta and Menarini Group signed an agreement for the product to be developed and commercialized for the treatment of ABSSSI under Menarini’s brands in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia.
Hospital-Treated Community-Acquired Bacterial Pneumonia (hCABP)
Melinta has initiated a Phase 3 program in hospital-treated community-acquired bacterial pneumonia (CABP) and plans to develop additional indications such as complicated urinary tract infections (cUTI). Quinolones are considered a standard of care in the treatment of CABP and cUTI.
Melinta has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA for the ABSSSI and CABP indications, which provides Baxdela with priority review and extends its market exclusivity period by an additional 5 years beyond the 5 years provided by Hatch-Waxman legislation.
Outside of the U.S., Menarini and Melinta are co-developing Baxdela (known as delafloxacin outside of the U.S.) for hCABP. The companies will design and share in the cost of clinical trials for this and other indications that may be pursued under the collaboration.
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