Last updated on April 18, 2014 at 11:57 EDT

Affinium Pharmaceuticals Announces Qualified Infectious Disease Product (QIDP) Designation by the US FDA for AFN-1252 and Completion of Dosing of AFN-1720 Phase 1 Trial

November 12, 2013

AUSTIN, TX and TORONTO, ON, Nov. 12, 2013 /PRNewswire/ – Affinium
Pharmaceuticals (“Affinium”) announced today that the U.S. Food and
Drug Administration (FDA) has designated Affinium’s Phase 2 antibiotic,
AFN-1252, as a Qualified Infectious Disease Product (QIDP) for use in
acute bacterial skin and skin structure infections (ABSSSI) based on
the Phase 2 study recently completed in that indication. The QIDP
designation is expected to enable Affinium to benefit from FDA
regulatory incentives for new antibiotics, including priority review,
and a five year extension of new chemical entity exclusivity.

“We are very pleased to receive the QIDP designation for our
ground-breaking staphylococcal-specific antibiotic, AFN-1252″, says Dr.
Ed Mascioli, Chief Executive Officer of Affinium. “It provides
important acknowledgment that Staphylococcus continues to be a major pathogen with significant unmet needs.”

In addition, Affinium today announces that it has completed dosing of
the planned IV Phase 1 single ascending dose study of AFN-1720, the
prodrug of AFN-1252. All planned cohorts for the Phase 1 study were
dosed and results will be available in the coming weeks.

About AFN-1720 and AFN-1252

AFN-1720 is a new prodrug of Affinium’s successful clinical-stage drug,
AFN-1252, and represents a new clinical-stage agent in this novel class
of antibiotics. Due to the unique, staphylococcal-specific spectrum of
AFN-1252, AFN-1720 is expected to preserve the human gut microbiome
resulting in minimal antibiotic-associated side effects, such as
antibiotic-induced diarrhea or C. difficile overgrowth. Clinical data observed to date support this concept.
Additionally, with no resistance pressure on other bacterial species,
the development of multiple drug-resistant organisms like
vancomycin-resistant enterococci (VRE) is unlikely. Oral and IV
AFN-1720 are being developed for clinical use in several serious
infections. AFN-1252, the parent molecule of AFN-1720, is 3-20 times
more potent than linezolid in animal models of infection, and is
exquisitely potent against all strains of Staphylococcus aureus, with an MIC(90) of 0.016 mg/ml against 5,400 strains of Staphylococcus aureus tested to date including all known resistant strains such as MRSA and
vancomycin-intermediate S. aureus (VISA). In clinical trials, AFN-1252 has demonstrated an excellent
efficacy, safety and tolerability profile in over 250 subjects.

About Staphylococcal Infections

Staphylococcus is the mostly commonly identified bacterial pathogen in man and is a
potential pathogen in almost every type of bacterial infection.
Methicillin-resistant strains of S. aureus (MRSA) account for about half of all S. aureus strains in the US and cause significant morbidity and mortality
worldwide. According to the Infectious Disease Society of America
(IDSA), MRSA kills more Americans every year than emphysema, HIV/AIDS,
Parkinson’s Disease and homicides combined.

About Affinium Pharmaceuticals

Affinium Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the development of novel anti-infective medicines based on
bacterial fatty acid synthesis inhibition. The antibacterial program
constitutes a new antibiotic platform with the potential for multiple
patented products inhibiting bacterial fatty acid synthesis in several
different bacterial species.

SOURCE Affinium Pharmaceuticals

Source: PR Newswire