Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned phase 3 study of its novel once-daily oral antibiotic Restanza to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.

The double-blind pivotal superiority study will compare the efficacy and safety of once-daily oral administration of 300 milligrams of Restanza over seven days of treatment to azithromycin. The primary efficacy endpoint will be the clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population. The protocol also includes several unique features, such as the inclusion of patient-reported outcome measures, which have the potential to generate a more robust demonstration of effectiveness and establish Restanza as a new standard of care in treating pneumonia.

With reported resistance rates as high as 40 per cent to standard-of-care macrolide antibiotics in the US, there is a pressing medical need for new drugs to treat CABP. Based on the data Advanced Life Sciences has accumulated in its extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, the company believes that Restanza has the potential to show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs.

"We are pleased that the FDA has agreed to a SPA which provides a clear pathway to approval for Restanza in the CABP indication, and which is designed to meet the needs of the community, industry and regulators," said Michael T. Flavin, Ph.D. CEO of Advanced Life Sciences. "We believe that the superiority-based SPA represents a precedent-setting clinical trial design for oral antibiotics and will make a significant contribution to the field of CABP and antimicrobial clinical trial design. Regulators, industry and experts in the field have long recognized the need for clinical design protocols that will help to bring innovative and important antimicrobial therapies to the market. Advanced Life Sciences welcomes the opportunity to demonstrate the broad efficacy of our unique product candidate and to play a leadership role in advancing the science and clinical practice of treating pneumonia."

Continued Dr Flavin: "Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumonia. Importantly, this approach will provide Advanced Life Sciences a viable path to move Restanza towards approval and commercialization."

An SPA is a written agreement between the FDA and a drug sponsor concerning the clinical trial design, clinical endpoints and other clinical trial issues that can be used to support regulatory approval of a drug candidate. The process is intended to provide assurance that if the agreed upon clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favourable risk benefit profile, the data may serve as the primary basis of an efficacy claim in support of a New Drug Application.

CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion for prescribed antibiotics to treat CABP. CABP is potentially fatal if not treated properly, and the bacteria that cause CABP are developing resistance to current standard of care treatments.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CABP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of CABP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria including CA-MRSA and pathogens associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.