In a recent interview with PharmaShots, Dr. Neil Collinson, the Senior Principal Clinical Development Scientist at Genentech / Roche shares his insights and highlights on Xofluza.

Shots:

• The P-III BLOCKSTONE study demonstrated that the proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza as compared to PBO (2% vs 14%), representing an 86% reduction in risk
• If approved, Xofluza for oral suspension will be administered as a single dose and will be available for children and those who have difficulty swallowing or the inability to swallow with its anticipated PDUFA date as Nov 23, 2020
• Xofluza can not be treated as a treatment for COVID-19 as it is specifically designed to treat influenza viruses only. Xofluza is a first-in-class, one-dose oral medicine with a novel proposed MOA that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication

Tuba: A quick highlight of the detailed results of the P-III BLOCKSTONE Xofluza study? (Something exclusive for PharmaShots readers, which is not yet published)

Neil: The New England Journal of Medicine recently published results from the Phase III BLOCKSTONE study, which evaluated Xofluza compared with placebo as a preventive (prophylactic) treatment for household members (adults and children) who were living with someone who had been diagnosed with influenza.

In the study, Xofluza showed a significant prophylactic effect on influenza infection after a single oral dose in people exposed to an infected family member. The proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza compared to those treated with placebo (proportion of household members with influenza virus infection, fever and other flu symptoms in the 10-day observation period: 2% versus 14%, p<0.0001, demonstrating an 86% reduction in risk). Xofluza was well tolerated, with no safety signals identified.

Tuba: How do results from P-III MINISTONE-2 study and P-III CAPSTONE 1&2 study fit in with P-III BLOCKSTONE?

Neil: We have robust clinical data supporting Xofluza as a treatment for influenza in multiple patient populations, including otherwise-healthy (CAPSTONE-1) and high-risk patients with influenza (CAPSTONE-2). The miniSTONE-2 data evaluating Xofluza in children age 1 to 12 with influenza, along with the BLOCKSTONE data looking at Xofluza as a prophylactic treatment for influenza add to the body of evidence supporting Xofluza in additional patient populations and treatment settings, and we continue working with the FDA to potentially expand the use of Xofluza in these settings.

Tuba: Can you share some details on the novel mechanism of the Xofluza?

Neil: Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

We expect the additional formulation of Xofluza as a granule, oral suspension to be available during the 2020-2021 flu season in the US

Tuba: As the US FDA has accepted an sNDA for a new suspension formulation of Xofluza, what would be your commercialization strategy (If approved)?

Neil: If approved, Xofluza for oral suspension will be administered as a single dose and will be available for children and those who have difficulty swallowing or the inability to swallow. We expect the additional formulation of Xofluza as a granule, oral suspension to be available during the 2020-2021 flu season in the U.S. The FDA is expected to make a decision by November 23, 2020.

Tuba: What are the other indications Genentech is planning to assess Xofluza in?

Neil: Xofluza is being further studied in a Phase III development program, including children under the age of one (miniSTONE-1), as well as to assess the potential to reduce transmission of the flu from an infected person to healthy people (CENTERSTONE).

Tuba: Who do you think are present and upcoming major competitors of Xofluza globally?

Neil: We do not comment on competitors in the infectious disease space

Tuba: How do you think Baloxavir can help reduce the risk of transmission, mainly in influenza outbreaks?

Neil: Influenza is highly contagious and is transmitted in airborne respiratory droplets when someone coughs, sneezes or talks. It can also live on some surfaces for up to 48 hours and can spread if someone touches the surface and then touches their mouth or nose. The FDA accepted an sNDA for Xofluza that seeks approval for the treatment of post-exposure prophylaxis of influenza in people one year of age and older. We continue working with the FDA to expand the Xofluza label as a preventive treatment following exposure to influenza. 

Xofluza is also being studied to assess the potential to reduce transmission of the flu from an infected person to healthy people (CENTERSTONE).

Tuba: How do you think this drug will affect the family-based community?

Neil: According to the CDC, the 2019-2020 flu season was one of the worst influenza seasons for children in the past decade. There is a critical need for additional treatment options that work in different ways to attack influenza. The recent FDA acceptance for pediatric and post-exposure prophylaxis use brings us closer to providing single-dose Xofluza to children with influenza and as preventive treatment following exposure to influenza.

Tuba:  Is Genentech planning for any digital initiative to increase patient outreach or to increase adherence or attract more pediatric population?

Neil: It is too premature to discuss marketing strategies for Xofluza in the pediatric setting.

Tuba: Do you think Xofluza can be effective as a potential treatment for COVID-19 anywhere in the future?

Neil: No. Xofluza is FDA-approved to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. Although some of the symptoms of COVID-19 and influenza can look similar, the two illnesses are caused by completely different viruses. Xofluza is specifically designed to treat influenza viruses only and has not been proven to be effective to treat human coronaviruses such as COVID-19.

Image Source: Medical News Today

About Dr. Neil Collinson:

Dr. Neil Collinson is the Senior Principal Clinical Development Scientist at Genentech/Roche and has joined Roche in 2007 as a Clinical Science Specialist. He is serving Roche for the last 13 years. He has done his Ph.D. from the University of Sussex