British Biotech and GeneSoft announce the start of human trials for the first-in-class antibiotic BB-83698

01 October 2002

Eight presentations given at 42nd ICAAC on research into new metalloenzyme-targeted antibiotics

British Biotech plc (BBG: LSE, Nasdaq: BBIOY) and GeneSoft Pharmaceuticals, Inc. announce today the start of human testing of the novel antibiotic and peptide deformylase (PDF) inhibitor, BB-83698. The Phase I dose-escalation study of BB-83698 is the first-ever clinical evaluation of a PDF inhibitor, a potential new class of antibiotics.

Targeting bacterial metalloenzymes represents a novel approach to the treatment of infectious disease. Certain of these enzymes, including PDF, have been found to be essential for bacterial survival. Research and pre-clinical studies on PDF inhibitors have shown high potency against bacteria that cause pneumonia and other serious infections, including strains resistant to current antibiotics. British Biotech and GeneSoft are now working together to discover and develop additional anti-infective drugs based on proprietary metalloenzyme inhibitors.

BB-83698 Phase I study
BB-83698 is targeted at community-acquired pneumonia in hospitalised patients. The initial Phase I, blinded, placebo-controlled study is designed to assess the safety and pharmacokinetics of single doses of an injectable formulation of the compound. Dosing will start at 10mg and will be escalated in line with emerging safety and pharmacokinetic data.

This study initiates the Phase I programme for BB-83698, which is expected to be completed in approximately 12 months. Under the agreement between British Biotech and GeneSoft signed in August this year, British Biotech will now receive a payment of US$1 million and equity representing 3.45 per cent of GeneSoft.

ICAAC presentations
Growing scientific interest in PDF has just been reflected at the 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), which took place from 27-30 September 2002 in San Diego, California. ICAAC is the premier international scientific meeting on infectious disease and developments in anti-infective medicine.

At the conference, British Biotech contributed an oral presentation in a symposium devoted to bacterial metalloenzymes and the potential for mechanism-based drugs such as BB-83698 to provide the next new class of antibiotics. British Biotech scientists and external investigators also presented seven posters on related antibiotic research. These posters described the in vivo and in vitro activities of BB-83698 and other potent PDF inhibitors against a variety of respiratory tract and other infections; the results of experiments investigating bacterial resistance to PDF inhibitors compared with antibiotics currently in use; and the characterisation of other novel metalloenzyme inhibitor compounds with antibacterial activity.

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