Business Wire

Pimodivir Alone or in Combination with Oseltamivir Demonstrated a Significant Reduction in Viral Load in Adults with Influenza A

14.6.2017 13:50 | Business Wire

Jaa

Janssen Pharmaceuticals, Inc. (Janssen) today announced results from the Phase 2b Topaz Trial which demonstrated that treatment with pimodivir (JNJ-63623872) significantly decreased viral load over seven days versus placebo, in adult patients with acute, uncomplicated seasonal influenza A. Patients treated with pimodivir and oseltamivir (OST) also demonstrated a significantly lower viral load compared with those who received pimodivir alone at the same dose.

The primary endpoint data for the trial, presented in an oral presentation at the 5th International Society for Influenza and Respiratory Diseases Antiviral Group (ISIRV-AVG) Conference in Shanghai, China, showed treatment with pimodivir resulted in a statistically significant decrease in area under the curve (AUC) of viral load (by quantitative real-time-polymerase chain reaction [qRT-PCR]) over seven days from start of dosing, compared with placebo.

Comparison   Pimodivir 300 mg vs placebo   Pimodivir 600 mg vs placebo   Pimodivir 600 mg + OST 75 mg vs placebo   Pimodivir 600 mg + OST 75 mg vs pimodivir 600 mg
Change in AUC viral loada
(95% CI)
-3.6
(-7.1; -0.1)
-4.5
(-8.0; -1.0)
-8.6
(-12.0; -5.1)
-4.1
(-7.4; -0.7)

a[day*log10 copies/mL]; AUC, area under the concentration time curve; CI, confidence interval; OST, oseltamivir

Differences in AUC are adjusted for baseline viral load and time from onset of influenza symptoms to the start of treatment (≤24 hours or >24 to 48 hours).

No significant safety concerns were noted with pimodivir treatment in the study. The most frequently reported treatment-emergent adverse events were diarrhea and nausea. Incidences of diarrhea (reported mostly as loose stool without increased frequency) were more common in individuals treated with pimodivir 600 mg (as mono- or combination therapy) than those treated with pimodivir 300 mg or placebo.

Pimodivir received U.S. FDA Fast Track designation in March 2017 due to its potential to address an unmet medical need in those who develop influenza A infection and who are hospitalized or at high risk of related complications. Phase 3 studies are anticipated to start in the second half of 2017.

“Influenza is one of the most serious global public health threats and important concerns remain about the emergence of antiviral resistance and the lack of approved medications for use in people hospitalized with the virus. Through the development of pimodivir, Janssen aims to provide a treatment option for people infected with the influenza A virus that will address these gaps,” said Julian A. Symons, D.Phil., Vice President, Disease Area R&D Leader, Respiratory Infections, Janssen. “The results of the Phase 2b study demonstrated that pimodivir, given either alone or with oseltamivir, significantly decreased the influenza viral load and therefore, if successfully developed and approved, could be an important treatment option for influenza A.”

Pimodivir, discovered by Vertex Pharmaceuticals*, is a first-in-class inhibitor of the PB2 subunit of the influenza A polymerase complex. By targeting an alternative part of the viral replication process, pimodivir may successfully treat influenza A virus infections that have developed resistance to existing antiviral drugs with other modes of action. The pimodivir development program receives funding support from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, under contract HHSO100201500014C.

Influenza, which is commonly known as “the flu,” remains one of the most serious public health challenges. Worldwide there are more than one billion cases each year, resulting in approximately five million cases of severe illness and up to half a million deaths. In addition to the burden of seasonal influenza, the pandemics of the 20th and 21st centuries exemplify the threat the influenza virus presents; in 1918, the Spanish influenza pandemic alone caused approximately 50 million deaths worldwide. In an effort to combat antiviral resistance and address the global need for new and improved treatment options against influenza, Janssen is committed to exploring the development of multiple compounds with differing mechanisms of action.

*In 2014, Janssen entered into an exclusive license agreement with Vertex for the worldwide development, manufacturing and commercialization of pimodivir

###

Notes to editors

About the Topaz Trial

The Topaz Trial is a Phase 2b study of pimodivir as monotherapy or in combination with OST in the treatment of acute uncomplicated seasonal influenza. The goal of this outpatient, community trial was to evaluate different pimodivir doses, explore dose-response relationships, and to evaluate the effectiveness of combination therapy with OST. The primary endpoint for the study was viral load, measured by qRT-PCR and viral culture. Secondary endpoints for the trial included time to resolution of seven primary influenza symptoms. Patients in the trial were randomized to one of four treatments and were followed for 14 days:

  • Pimodivir 300 mg + placebo (n=58)
  • Pimodivir 600 mg + placebo (n=57)
  • Pimodivir 600 mg + OST 75 mg (n=57)
  • Placebo + placebo (n=51).

Safety was assessed via adverse events, clinical laboratory assessments, ECGs, vital signs and physical examination.

About Janssen

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us at @JanssenGlobal.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development, including the anticipated start of phase 3 studies for a potential new treatment for influenza A. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Contact information

Janssen
Media Contact:
Katie Buckley
+44 7971 956 179
kbuckle8@its.jnj.com
or
Investor Relations:
Lesley Fishman
Phone: +1 732-524-3922

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Announcement from SII Semiconductor Corporation: Change of Company Name24.8.2017 09:00Tiedote

SII Semiconductor Corporation (President: Nobumasa Ishiai, Head Office: Chiba-shi, Chiba; hereinafter “SII Semiconductor”), a subsidiary of Seiko Instruments Inc. (President: Hitoshi Murakami, Head Office: Chiba-shi, Chiba; hereinafter “SII”), that manufactures and sells semiconductors today announced that the company will change its company name to ABLIC Inc. in January 5, 2018. SII Semiconductor was established in September 2015. Through a joint investment by Development Bank of Japan Inc. (President & CEO: Masanori Yanagi, Head Office: Chiyoda-ku, Tokyo; hereinafter “DBJ”) in January 2016, SII Semiconductor has deployed and expanded its business by succeeding the SII’s semiconductor business. Currently the equity of SII Semiconductor is split to 60% for SII and 40% for DBJ, but SII will transfer its 30% of the equity to DBJ and DBJ will acquire 70% after January 2018. Taking adv

Ford Names New Chairman and CEO for Ford China; New Vice President of Powertrain Engineering24.8.2017 01:00Tiedote

Ford Motor Company today announced a new chairman and CEO of Ford China and head of Powertrain Engineering as it continues to strengthen its global leadership team. Jason Luo is named chairman and CEO Ford China. In his new role, Luo will lead all of the company’s operations in Greater China including its import business, Lincoln, its passenger car joint venture Changan Ford, commercial vehicle investment in Jiangling Motors Corporation, and our operations in Taiwan. Luo, 51, joins Ford from Key Safety Systems, the fastest growing company in the automotive safety market, where he was global president and CEO for the past 10 years. While at Key Safety Systems, he led the business transformation and global expansion of the company and achieved significant revenue growth in China. Luo will be based in Shanghai, reporting to Peter Fleet, Ford group vice preside

Tech21 Announces New Collection Designed to Protect the Samsung Galaxy Note8 Drop After Drop.23.8.2017 20:30Tiedote

Tech21, the leader in impact protection for mobile devices, today announced a new collection of innovative cases and screen shields for the Samsung Galaxy Note8 made of unique, patented impact protection materials that guarantee the most effective drop protection on the market. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170823005888/en/ Evo Tactical for Samsung Galaxy Note8 (Photo: Business Wire) Tech21 products are designed to protect, drop after drop. The company does this by using scientifically proven impact materials, innovative design and a rigorous testing methodology developed in partnership with the National Physical Laboratory. Tech21 cases are drop tested 20 times to ensure durability and long lasting protection able to withstand the multiple drops that occur in the everyday

2018 AQR Insight Award Call for Papers23.8.2017 18:45Tiedote

AQR Capital Management, LLC (“AQR”) today began accepting submissions for the seventh annual AQR Insight Award. The AQR Insight Award recognizes and rewards exceptional academic papers that have practical applications and offer original, intelligent approaches to issues in the investment world. Up to three papers share a $100,000 annual prize. Winners are chosen by the AQR Insight Award Committee, a panel of senior members of the firm, many of whom are leading academic finance experts from top universities. AQR will accept papers on any investment-related topic as long as they deliver clear, significant insights. Papers must not be published before October 1, 2017. The deadline for entries is November 1, 2017. The Committee will then narrow the finalists to five papers, and the authors of those papers will be invited to present their research to

ANA Announces New Online Content "IS JAPAN COOL? DOU"23.8.2017 18:00Tiedote

Today, All Nippon Airways Co., Ltd. (ANA), Japan’s largest and only 5-Star airline, is proud to announce the launch of its new online content “IS JAPAN COOL? DOU,” which illustrates traditional Japanese culture through the use of cutting-edge technology. This content can be seen on “IS JAPAN COOL?,” a website that promotes tourist destinations and popular Japanese cultures to the world. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170823005024/en/ "IS JAPAN COOL? DOU" TOP (Graphic: Business Wire) While Japan is widely known for its unique pop culture, “IS JAPAN COOL?,” which launched in 2012, has put much of its focus on promoting Japan’s modern culture. As the number of tourists visiting Japan exceeded 24 million people as of 2016, the project aims to provide a deeper understa

Emailage Receives $10 Million Growth Equity Investment to Accelerate Global Expansion23.8.2017 17:00Tiedote

Emailage, the leading provider of global fraud prevention and identity verification using email address scoring, today announced that it has received a $10 million growth equity investment. Anthos Capital led the investment, with participation from Radian Capital, Wipro Ventures, Mucker Capital and Tallwave Capital. Emailage will use the funding to expand existing partnerships, further advance its powerful email address-based predictive scoring system, and accelerate growth in North America, EMEA, LATAM and other key markets. “This investment will allow us to continue our rapid growth, enhance our leadership position in the online fraud detection market and deliver significant fraud prevention capabilities to businesses around the world,” said Emailage CEO Rei Carvalho. Emailage’s Software-as-a-Service solution delivers powerful, real-time risk intelligence by leveraging the

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme