About Valevia


Valevia - Overcoming Pathogenic Resistence

The company was founded in 2009 as Valevia GmbH in Switzerland to develop antibacterial medications. AVX13616 (now VAL301) was licensed from the Australian drug development company Avexa Ltd. Subsequently, the company headquarters were moved to the UK in 2012 and was renamed Valevia UK. Valevia’s lead project is supported by a TSB feasibility grant, which was awarded in 2013.

Valevia is a virtual company with laboratory and research work performed in collaboration with universities and contract research organizations (CROs).

ABOUT VAL301
VAL301 is a novel antibiotic derived from a new chemical class. It is rapidly bactericidal, with a long post-antibiotic effect. The absence of cross-resistance to other common classes of Gram-Positive antibiotic drugs suggests a novel mode of action and a low propensity for emergence of endogenous resistance. Animal models of nasal colonization and wound infection have demonstrated efficacy against community-acquired and hospital-acquired MRSA strains. The pharmacokinetic and toxicological profiles are compatible with oral administration for treatment of Clostridium difficile and topical administration. VAL301 was discovered at Avexa Ltd, and is being developed under a collaboration between Avexa Ltd and Valevia UK.

About Clostridium Difficile:
Clostridium difficile is a gram-positive, spore-forming anaerobic bacillus, which is the causative agent of pseudomembranous colitis and Clostridium difficile Associated Diarrhoea (CDAD) – a serious illness in which C. difficile proliferates and produces toxins, causing inflammation and severe diarrhoea, which can prove fatal. Global C.difficile prevalence has been  increasing since the late 1990s, driven by increased use of broad-spectrum antibiotics, chemotherapeutic agents and agents to suppress gastric acid production (all of which wipe out the normal gut flora), as well as the emergence of resistant and hyper-virulent strains (such as BI/NAP1/027) which produce lethal toxins. Although historically CDAD has been a hospital acquired infection, the onset of infection is now increasingly occurring outside of hospital. Furthermore CDAD is occurring more frequently in groups previously thought to be low-risk.  Valevia is developing an experimental drug, VAL301 which has already demonstrated in vitro efficacy against hyper-virulent strains of C.difficile and strains with reduced susceptibility to current therapies. The serious lack of antibiotics is recognized worldwide, as shown by the recent establishment of the US GAIN (Generating Antibiotic Incentives Now) Act, which provides an additional 5 years of market exclusivity for qualifying new antibiotics.

The US CDC classified Clostridium difficile as an urgent public health threat with 250 000 infections requiring hospitalizations and 14 000 deaths a year in the US (http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_infect.html; http://www.cdc.gov/drugresistance/threat-report-2013/). The indicence is increasing. Recent data from 28 community hospitals in the Southern US suggest C. difficile has replaced MRSA as the most common cause of healthcare-associated infection.  US hospital discharge data indicate that the number of subjects discharged having either been admitted with C. difficile infection (CDI) or acquiring it during admission, increased from 3.82 per 1000 discharges in 2000 to 8.75 in 2008 and during that time the number of deaths increased almost 10-fold.

Data from the Healthcare Utilisation Programme demonstrate that C.difficile associated disease (CDAD) patients are considerably sicker and more complex than the average inpatient on every measure. The length of hospital stay for CDAD patients is nearly threefold higher than average, and the death rate in hospital 4.5 times higher.

FACTS & FIGURES

About Antibiotic Development
Drugs for serious infections constitute a self-perpetuating market due to the inevitable emergence of antibiotic resistance. The rapid spread of MDR Gr(+) and Gr(-) bacteria is addressed inadequately by available products, establishing a large medical need for new antibiotics. Although generally-speaking, antibacterials are associated with lower development risk than drugs in other therapeutic areas due to the relatively high accuracy of projections of clinical efficacy from in vitro testing, relevant animal models of infectious diseases, and experimental and simulated PK/PD, in the past decade, increasingly complex, shifting and uncertain regulatory hurdles have contributed to the erosion of this advantage, causing some key companies to exit the field. However, the GAIN (Generating Antibiotics Incentives Now) Act, approved by FDA in 2012, provides pharmaceutical and biotechnology companies with renewed incentives to develop innovative antibiotics for the treatment of certain infectious diseases caused by specified drug resistant pathogens. Such antibiotics are called Qualified Infectious Disease Products (“QIDPs”) under the GAIN Act and afforded incentives like an additional 5 years of Exclusivity, thus having a 10 year market exclusivity with or without patent. In addition, they will receive Priority Review of 8 months and Fast Track Status potentially speeding the path from Phase I to NDA filing.