Shanghai, China – June 14, 2017 – 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.
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
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.
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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.
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