MediVector Completes Patient Enrollment in Two Phase 3 Studies of Favipiravir for Influenza

Boston, February 17, 2015 -More than 2,000 patients enrolled in the Americas, Europe, Australia, New Zealand and South Africa-

MediVector, Inc. today announced it has successfully completed enrollment in two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza (often called the “flu”).  The two studies enrolled 2,021 patients in participating clinics and practices in the Americas, Europe, Australia, New Zealand and South Africa. Favipiravir is an orally administered novel anti-viral compound with a unique mechanism of action that is active against a wide range of RNA-based viruses in laboratory tests.

“Completion of enrollment within a year of initiating these clinical trials is a significant accomplishment, and the resulting data from the carefully designed studies will lay the groundwork for filing an application for approval to market favipiravir in the U.S.,” Dr. Carol Epstein, Executive Vice President and Chief Medical Officer of MediVector, Inc. said.  “Resistance to currently available influenza treatments is a growing problem, and there is an urgent need for a new broad-spectrum therapeutic with a different mechanism of action that is active against multiple strains of influenza viruses.”

The randomized, double-blind, placebo-controlled, multi-centered Phase 3 FAVOR studies are evaluating the time to alleviation of all primary influenza symptoms consistent with uncomplicated influenza, after treatment with favipiravir. Primary symptoms include cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Additional outcome measures include reduction in virus and safety. Favipiravir is orally administered for five days, with a higher dosage level on day one. The first study includes patients (1161) from the Americas and the second study includes patients (860) from the United States, Europe, Australia, New Zealand and South Africa. Data review is ongoing and study reports will be provided to FDA once complete.

Favipiravir is being developed by the Department of Defense’s BioDefense Therapeutics (BDTX), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office.

“We are pleased with the rapid enrollment of these clinical trials, and are hopeful the results will reinforce the promise seen in earlier studies,” said Lieutenant Colonel Eric G. Midboe, US Army, Joint Project Manager for BDTx. “Favipiravir may represent an important new therapeutic to protect our military and nation when a vaccine fails to protect against an emerging influenza strain, a drug resistant influenza, and other RNA-virus threats.”

 

About Favipiravir
Favipiravir (originally known as T-705) is a broad-spectrum antiviral candidate discovered in Japan by Toyama Chemical Co, a unit of Fujifilm Holdings.  It is a novel anti-viral compound that works by a different mechanism than approved antiviral agents used to treat people who have become ill with influenza. Favipiravir inhibits synthesis of viral RNA genomes and messenger RNAs that produce the proteins that will form new viruses.  Laboratory studies indicate that favipiravir may also be effective against a variety of other RNA viruses.

In a 530 patient Phase 2 multi-center, double-blind, placebo-controlled study in the United States, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of the six influenza symptoms.  In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir was well tolerated with no serious adverse events reported during this study.

 

About Influenza

Influenza is a contagious respiratory illness that can cause mild to severe illness and in some cases can result in hospitalization or death. Older people, young children and people with serious health conditions are at the highest risk of complications from influenza. Currently three anti-viral drugs are approved by the FDA for treating influenza, oral Tamiflu® (oseltamivir), inhaled Relenza® (zanamivir) and intravenously-administered Rapivab® (peramivir). Drug resistance is a growing problem and there is a need for new classes of drugs with novel mechanisms of action.

 

About MediVector, Inc. 

MediVector, Inc. is a Boston-based drug development company specializing in decreasing the time and cost of bringing drugs to market.  The company complements its team’s clinical development, regulatory and science expertise with proprietary processes and software based decision support systems and data management tools. MediVector’s management team has a track record of successfully transforming innovative therapeutics with highly challenging clinical and regulatory hurdles into blockbuster drugs that address unmet medical needs and improve public health. For more information please visit www.medivector.com.

 

About Joint Project Manager Medical Countermeasure Systems (JPM-MCS)

The U.S. Department of Defense’s JPM-MCS is one of seven JPMs within the Joint Program Executive Office for Chemical and Biological Defense. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation’s biodefense response capability.  MCS-BDTX—a  component of JPM-MCS—develops Food and Drug Administration-approved therapeutics that provide prophylaxis and treatment for traditional, emerging and engineered viral, bacterial and toxin biological warfare agents.

First Patient Enrolled in Northern Hemisphere for Phase 3 Study of Favipiravir for Influenza

BOSTON, Jan. 16, 2014 — MediVector, Inc. today announced the enrollment of its first patient in the United States in one of two FAVOR favipiravir Phase 3 studies in adults with uncomplicated influenza.  This multi-center, double-blind, placebo-controlled study is expected to enroll over 1,000 patients in participating clinics and practices in North, Central, and South America.

“The burden of seasonal influenza is substantial, resulting in hundreds of thousands of deaths each year worldwide.  We see the potential for this drug to serve a crucial public health need,” Dr. Carol Epstein, Executive Vice President and Chief Medical Officer of MediVector, Inc. said.  “With illness and death from pandemic flu an ever present threat, the importance of new drugs, like favipiravir, become more and more significant.  Many strains of influenza have developed resistance to currently-available drugs.”

The Phase 3 FAVOR study follows the successful completion of a Phase 2, multi-center, double-blind, placebo-controlled study in the United States with favipiravir in patients with uncomplicated influenza. In the Phase 2 study, twice daily dosing of favipiravir demonstrated statistically significant decreases in time to alleviation of each of six influenza symptoms consistent with uncomplicated influenza (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue).  In addition, subjects who received favipiravir cleared the virus statistically significantly more quickly compared with placebo. Favipiravir appeared safe and well tolerated with no serious adverse events reported during this study.

The investigational drug candidate (favipiravir) is being developed by BioDefense Therapeutics (BD Tx), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological and nuclear threats. JPM-MCS facilitates the advanced development and acquisition of medical countermeasures and systems to enhance our nation’s biodefense response capability. For more information, visit www.jpeocbd.osd.mil.

Favipiravir (originally known by the code name, T-705) is a novel anti-viral compound that works against a different viral enzyme target than approved antiviral agents used to treat people who have become ill with influenza.   Favipiravir inhibits the enzyme viral RNA polymerase that functions to make copies of the viral RNA segments and to synthesize mRNAs that produce the proteins that will form new viruses.  Favipiravir may be useful for the treatment of influenza infections based on its potent and selective inhibitory activities against a broad spectrum of influenza A, B, and C viruses, including strains poorly susceptible to existing drugs and its efficacy against highly pathogenic avian influenza and avian influenza virus A (H5N1) isolated from humans and birds in both in vivo and in vitro studies.  Preclinical studies indicate that favipiravir may also be effective against a variety of other viral illnesses.

Contact | 617.398.5900 info@medivector.com

DoD’s BioDefense Therapeutics Announces First Patient Enrolled in Phase 3 Clinical Trials for Favipiravir

BioDefense Therapeutics (BD Tx)—a Joint Product Management office within the U.S. Department of Defense (DoD)—announced the first patient enrolled in the North American Phase 3 clinical trials for favipiravir (T-705a). The drug is an investigational flu treatment candidate with broad-spectrum potential being developed by BD Tx through a contract with Boston-based MediVector, Inc.

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DoD’s BioDefense Therapeutics Announces Positive Results for Flu Treatment Drug

The successful completion of a Phase 2 double blind placebo-controlled clinical trial for the anti-influenza drug, T-705a (favipiravir), clears the way for Phase 3 clinical trials to begin in November. The investigational drug candidate is being developed by BioDefense Therapeutics (BD Tx)—a Joint Product Management office within the U.S. Department of Defense (DoD)—through a contract with Boston-based MediVector, Inc.

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MediVector Gets DoD Contract to Develop Flu Treatment

The Department of Defense’s (DOD) Joint Project Manager Transformational Medical Technologies (JPM-TMT) awarded a $138.5M contract to MediVector, Inc. to further develop Favipiravir (T-705), a broad-spectrum therapeutic against multiple influenza viruses, including the 2009 H1N1 pandemic virus and drug resistant influenza strains. The contract will help bolster the protection of the Joint Forces against naturally occurring pandemic influenza and/or biologically engineered flu viruses.

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JPM-TMT Announces Contract Award for Advanced Development of Broad-spectrum Influenza Drug

The Department of Defense’s (DOD) Joint Project Manager Transformational Medical Technologies (JPM-TMT) awarded a $138.5M contract to MediVector, Inc. to further develop Favipiravir (T-705), a broad–spectrum therapeutic against multiple influenza viruses, including the 2009 H1N1 pandemic virus and drug resistant influenza strains. The contract will help bolster the protection of the Joint Forces against naturally occurring pandemic influenza and/or biologically engineered flu viruses.

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MediVector, Inc. Awarded $138.5M to Advance Development of Emerging Infectious Diseases Medical Countermeasure Drug

MediVector, Inc., Boston, Mass., is being awarded a $138,500,000 cost-plus-fixed-fee contract for advance development of emerging infectious diseases medical countermeasure drug for the Federal Drug Administration licensure. Work will be performed in Boston, Mass., and is expected to be completed April 2016. Contract funds will not expire at the end of the current fiscal year. Solicitation was issued for full and open competition and four proposals were received. The Defense Threat Reduction Agency, Fort Belvoir, Va., is the contracting activity (HDTRA1-12-C-0031).

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