NIH FUNDS DEVELOPMENT OF NEW BROAD-SPECTRUM THERAPEUTICS

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> U.S. Department of Health and Human Services

> NATIONAL INSTITUTES OF HEALTH NIH News

> National Institute of Allergy and Infectious Diseases (NIAID)

<http://www.niaid.nih.gov/>

> For Immediate Release: Thursday, October 13, 2011

>

> CONTACT: Ann Mosher, 301-402-1663, <e-mail:niaidnews@...>

>

> NIH FUNDS DEVELOPMENT OF NEW BROAD-SPECTRUM THERAPEUTICS

> Five-year contracts could total $150 million, support research with emerging

infectious disease and biodefense applications

>

> Four companies are to develop broad-spectrum therapeutics-antibiotics,

antivirals and an antitoxin-to prevent or treat diseases caused by multiple

types of bacteria or viruses, under contracts awarded by the National Institute

of Allergy and Infectious Diseases (NIAID), part of the National Institutes of

Health. Total funding for the four contracts could reach $150 million over a

maximum five-year period.

>

> The contracts are designed to support essential research and development

activities to enable promising investigational therapies to move toward

early-phase clinical studies and, if successful in clinical studies, on to

eventual licensure. The ultimate goal is to develop products that the U.S.

government can stockpile to protect the public in the event of a bioterror

attack or public health crisis.

>

> In line with NIAID's strategic plan

(http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/Documents/biosp200\

7.pdf) for biodefense and emerging infectious diseases research, these contracts

move beyond the paradigm of drug development that is sometimes called " one-bug,

one-drug. " The contracts are to focus on candidate therapies that can be used

against classes of pathogens rather than being agent-specific. Such

broad-spectrum therapeutics would improve preparedness for all infectious

threats, whether they occur naturally or are deliberately introduced.

>

> The following companies are recipients of the new contracts:

>

> CUBRC Inc., Buffalo, N.Y., in partnership with Tetraphase Pharmaceuticals,

Watertown, Mass.--Researchers will develop a fully synthetic tetracycline

product, TP-271, to treat the bacterial disease tularemia, and respiratory

infections such as community-acquired bacterial pneumonia. Both intravenous and

oral formulations of the drug will be evaluated in preclinical studies for

safety and efficacy, and several preliminary 1 clinical trials are planned. The

compound will also be tested in nonclinical studies for activity against anthrax

and plague. The initial award is for $5.7 million, with the potential for up to

$35 million over five years.

>

> Enanta Pharmaceuticals Inc., Watertown, Mass.--Researchers will develop and

evaluate a candidate from a novel class of next-generation broad-spectrum

antibiotics known as bicyclolides. Bicyclolides are small-molecule

anti-infectives. Enanta's bicyclolide has demonstrated potential for activity

against anthrax, plague and tularemia in cell culture studies, as well as

efficacy against anthrax and tularemia in mice. The compound will be evaluated

for effectiveness against multiple bacteria that might be used as agents of

bioterror, and several Phase 1 clinical trials are planned. Bicyclolides

represent a promising new class of broad-spectrum antibiotics that have

demonstrated activity against the two major groups of bacteria, known as

gram-negative and gram-positive bacteria. These groups of bacteria are

distinguished by the presence or absence of peptidoglycan, which is visible in

lab specimens when the bacteria are stained using the Gram method. In general,

the two types of bacteria are treated using different types of drugs. The

initial award is for $14.3 million with the potential for a five-year total of

up to $43 million.

>

> Unither Virology LLC, Silver Spring, Md.--Unither will develop and evaluate

UV-4, an investigational antiviral drug with potential as a treatment for

influenza and dengue fever and possible applications for viral hemorrhagic

fever, smallpox and hepatitis. The drug is derived from a class of compounds

known as iminosugars that includes drugs approved for other indications, such as

diabetes and Gaucher's disease. UV-4, which may also reduce the potential for

drug resistance, is expected to undergo toxicity studies, a preliminary safety

study and a Phase 2 clinical trial for dengue fever. Unither has received an

initial award of $10.5 million with the potential for up to $45 million over

five years.

>

> XOMA (US) LLC, Berkeley, Calif.--The company will develop an intravenous

antitoxin to treat human botulism poisoning. XOMA's monoclonal antibody product

will target serotypes C and D of Clostridium botulinum neurotoxin and would also

neutralize C/D and D/c mosaic/hybrid toxins. The development of human botulinum

monoclonal antibodies would replace existing horse-based antitoxin products that

are difficult to make and pose safety concerns for humans. A preliminary

clinical trial is planned for XOMA's anti-C/D toxin product. The company

received $7 million in its initial NIAID award with the potential for up to $28

million in five years.

>

> NIAID conducts and supports research--at NIH, throughout the United States,

and worldwide--to study the causes of infectious and immune-mediated diseases,

and to develop better means of preventing, diagnosing and treating these

illnesses. News releases, fact sheets and other NIAID-related materials are

available on the NIAID Web site at <http://www.niaid.nih.gov>.

>

> About the National Institutes of Health (NIH): NIH, the nation's medical

research agency, includes 27 Institutes and Centers and is a component of the

U.S. Department of Health and Human Services. NIH is the primary federal agency

conducting and supporting basic, clinical, and translational medical research,

and is investigating the causes, treatments, and cures for both common and rare

diseases. For more information about NIH and its programs, visit <www.nih.gov>.

>

> ##

>

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> <http://www.nih.gov/news/health/oct2011/niaid-13.htm>.

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