Affinium Pharmaceuticals Announces the Initiation of a Phase 1 Intravenous Clinical Trial of a New Antibiotic Prodrug, and the Closing of a Follow-on Financing Round

AUSTIN, TX and TORONTO, ON, Sept. 4, 2013 /PRNewswire/ - Affinium Pharmaceuticals ("Affinium") announced today that it has initiated dosing in a Phase 1 intravenous (IV) clinical trial of its new antibiotic prodrug, AFN-1720.  AFN-1720 is the prodrug of the active drug, AFN-1252.  Initiation of this IV clinical study follows Affinium's 2012 successful oral Phase 2a clinical study demonstrating excellent safety, efficacy and tolerability in acute bacterial skin and skin structure infections (ABSSSI).

Affinium also announces today the closing of a follow-on funding round with its current investors which supports the continued development of AFN-1720.

AFN-1720, the AFN-1252 prodrug, is Affinium's lead compound in a completely new class of antibiotics inhibiting bacterial fatty acid biosynthesis inhibition. AFN-1252 is targeted specifically to Staphylococcus spp, the most common bacterial pathogen in man.  It demonstrates exquisite potency against all strains of Staphylococcus aureus (5400) tested to date, including all strains of MRSA.  Affinium will present recently generated data at several upcoming medical conferences and business meetings:

• Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC), September 10-13, Denver, CO.
• Translational Pharmacokinetic and Pharmacodynamic Modelling of the Anti-Staphylococcal Activity of AFN-12520000 in Humans and Selection of a Successful Phase 2 Dose.  09/10/2013 Exhibit Hall A, 12-2 PM, Poster A-010
• Phase 2a, Open-label, Multicenter Study of Oral AFN-12520000 in the Treatment of Acute Bacterial Skin And Skin Structure Infections Due to Staphylococci.  09/10/2013 Exhibit Hall A, 12-2 PM, Poster, L-206
• BioPharm America™ 2013: September 17-19, 2013 -Boston, Massachusetts, USA
• Microbiome / Microbiota R&D Business Collaboration Forum, October 7-8, San Diego, CA
• BioNetwork West 2013, October 28-30. Laguna Niguel, CA
• Windhover's Therapeutic Area Partnerships Conference, November 18-20, 2013, Boston, MA
• Affinium was selected by Windhover as one of the Top 10 Infectious Disease Projects to Watch

Recent scientific publications include:

• Pharmacokinetics, pharmacodynamics and efficacy of novel FabI inhibitor AFN-1252 against MSSA and MRSA in the murine thigh infection model. Banevicius et al., Journal of Chemotherapy, January 2013.
• Activity of AFN-1252, a novel FabI inhibitor, against Staphylococcus aureus in an in vitro pharmacodynamic model simulating human pharmacokinetics. Tsuji et al., Journal of Chemotherapy, January 2013
• In vitro activity (MICs and rate of kill) of AFN-1252, a novel FabI inhibitor, in the presence of serum and in combination with other antibiotics. Kaplan et al., Journal of Chemotherapy, January 2013.
• Perturbation of Staphylococcus aureus Gene Expression by the Enoyl-Acyl Carrier Protein Reductase Inhibitor AFN-1252. Parsons, et al., Antimicrobial Agents & Chemotherapy, 2013, 57(5):2182
• Is There a Future for FabI Inhibitors as Antibacterial Agents? Karchmer et al, Clinical Investigation, August 2013
• AFN-1252 In Vitro Absorption Studies and Pharmacokinetics Following Microdosing In Healthy Subjects.  Kaplan et al, European Journal of Pharmaceutical Sciences, August 2013

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.¹

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 lead clinical-stage agent in this novel class of antibiotics.  Due to its unique, staphylococcal-specific spectrum, 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 supports 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 is 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 MIC₉₀ of 0.016 µg/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 220 subjects.

About Affinium Pharmaceuticals

Affinium Pharmaceuticals is a development 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.

For more information, please visit our website:  www.afnm.com

SOURCE Affinium Pharmaceuticals