CLINICAL TRIALS PROFILE FOR XOFLUZA

All Clinical Trials for Xofluza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03959332 ↗	Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants	Completed	Shionogi	N/A	2019-06-19	This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
NCT03959332 ↗	Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants	Completed	Hoffmann-La Roche	N/A	2019-06-19	This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
NCT03969212 ↗	Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households	Recruiting	Hoffmann-La Roche	Phase 3	2019-10-10	Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
NCT04141930 ↗	Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle	Completed	Genentech, Inc.	Phase 4	2019-11-01	This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
NCT04141930 ↗	Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle	Completed	University of Washington	Phase 4	2019-11-01	This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
NCT04712539 ↗	Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients	Not yet recruiting	M.D. Anderson Cancer Center	Phase 2	2021-05-01	This phase II trial studies the effect of baloxavir in combination with oseltamivir in treating severe influenza infection in patients who have previously received a hematopoietic (blood) stem cell transplant or have a hematological malignancy. Baloxavir is an antiviral drug that inhibits the growth of influenza virus, reduces viral load and prevents further influenza infection. Osetamivir is an antiviral drug that blocks enzymes on the surfaces of influenza viruses, interfering with cell release of complete viral particles. Giving baloxavir in combination with oseltamivir may shorten or decrease the intensity of influenza infection compared to oseltamivir alone.
NCT05170009 ↗	Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza	Not yet recruiting	Genentech, Inc.	Phase 4	2022-01-01	This is a randomized, double-blind, placebo-controlled pilot study of the efficacy and safety of baloxavir in combination with oseltamivir (standard of care) for the treatment of influenza in allogeneic stem cell transplant patients. Although there are no data about this treatment option currently available, the investigator hypothesizes that combination therapy may be more effective in clearing influenza virus infection and decreasing the rate of emergence of resistant influenza in immunocompromised human hosts.

Clinical Trial Conditions for Xofluza

Condition Name

Condition Name for Xofluza
Intervention	Trials
Influenza	6
Healthy Volunteer	1
Hematopoietic and Lymphoid Cell Neoplasm	1
Infection Viral	1

Condition MeSH

Condition MeSH for Xofluza
Intervention	Trials
Influenza, Human	6
Virus Diseases	2
Infections	1
Coronavirus Infections	1

Clinical Trial Locations for Xofluza

Trials by Country

Trials by Country for Xofluza
Location	Trials
United States	28
India	9
Brazil	4
Mexico	3
China	2

Trials by US State

Trials by US State for Xofluza
Location	Trials
Texas	2
Pennsylvania	2
California	1
Arkansas	1
Arizona	1

Clinical Trial Progress for Xofluza

Clinical Trial Phase

Clinical Trial Phase for Xofluza
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Xofluza
Clinical Trial Phase	Trials
Not yet recruiting	3
Completed	2
Recruiting	2

Clinical Trial Sponsors for Xofluza

Sponsor Name

Sponsor Name for Xofluza
Sponsor	Trials
Genentech, Inc.	3
Hoffmann-La Roche	2
Shionogi	1

Sponsor Type

Sponsor Type for Xofluza
Sponsor	Trials
Industry	6
Other	5

Xofluza: A Revolutionary Influenza Treatment - Clinical Trials, Market Analysis, and Projections

Introduction to Xofluza

Xofluza, also known as baloxavir marboxil, is a groundbreaking antiviral medication developed by Shionogi and marketed by Roche's Genentech. It represents the first new flu antiviral with a novel mechanism of action in nearly 20 years. Here, we delve into the recent clinical trials, market analysis, and future projections for this innovative drug.

Mechanism of Action

Xofluza operates by inhibiting the cap-dependent endonuclease protein, which is crucial for the replication of influenza viruses. This mechanism not only reduces the duration of infectiousness but also the overall disease duration. It has shown efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains like H7N9 and H5N1[4].

Clinical Trials Update

CENTERSTONE Study

The most recent and significant clinical trial is the Phase III CENTERSTONE study. Conducted globally across 272 sites, this trial enrolled over 4,000 participants, including index patients (IPs) and their household contacts (HHCs). The study aimed to evaluate the efficacy of a single-dose oral administration of Xofluza in reducing the transmission of influenza within households.

The primary endpoint was the proportion of HHCs who contracted influenza within five days post-treatment with Xofluza or placebo. The results showed that Xofluza significantly reduced the likelihood of HHCs contracting the flu, meeting the trial's primary endpoint. Secondary endpoints also indicated a reduction in the proportion of HHCs who developed influenza symptoms by day five[1][4][5].

Blockstone Study

Another pivotal study is the Phase III Blockstone trial, conducted in Japan. This trial involved about 750 household contacts of 545 influenza patients and demonstrated that a single dose of Xofluza cut the risk of developing the flu by 86% compared to placebo. The study also showed significant benefits in subgroup analyses, including people at high risk of developing complications and children under 12 years of age[2].

Market Analysis

Current Market Status

Xofluza has been approved in over 80 countries for the treatment of uncomplicated influenza types A and B. In the U.S., it is approved for treating symptoms and preventing infection following virus exposure in people aged 12 years and older. Despite its innovative mechanism and efficacy, Xofluza's sales have been modest compared to its predecessor, Tamiflu, largely due to competition from cheap generics[2].

FDA Approvals and Label Expansion

In November 2020, the FDA approved Xofluza for post-exposure prophylaxis in people aged 12 years and older following contact with an infected person. This approval added a new indication to Xofluza’s existing uses, potentially boosting its market performance. However, the FDA did not approve the granules formulation for younger patients at that time, limiting its reach to children under 12 years old[2].

Sales Performance

Since its introduction in October 2018, Xofluza has not achieved the blockbuster status that Tamiflu once enjoyed. In the first quarter of its launch year, Xofluza generated only CHF 28 million ($31 million) in sales. The new label expansion for post-exposure prophylaxis is expected to enhance its market performance, especially given the potential larger market for post-exposure prophylactic use[2].

Market Projections

Potential Market Growth

The recent positive results from the CENTERSTONE study are expected to further bolster Xofluza's market position. The demonstration of transmission reduction benefits could make Xofluza a critical tool in influenza pandemic preparedness and community health strategies. This new evidence may lead to increased adoption by healthcare providers and public health organizations, potentially driving up sales[4][5].

Expansion to Younger Patients

Roche is working on a path forward with the FDA to expand Xofluza’s use for uncomplicated influenza and post-exposure prophylaxis in children aged 1 to 12 years. If successful, this expansion could significantly increase the drug's market potential, given that children are a high-risk group for severe influenza infections[2].

Global Health Impact

Xofluza’s ability to reduce the transmission of influenza within households is a significant advancement in public health. This could lead to better health outcomes at both individual and community levels, especially during flu seasons complicated by other respiratory illnesses like COVID-19. As Levi Garraway, Roche’s Chief Medical Officer, noted, "This new evidence of transmission reduction represents an important advance that could help improve health outcomes at an individual and community level"[5].

Safety and Tolerability

Xofluza has been well-tolerated in clinical trials, with no new safety signals identified. This is a crucial factor in its adoption, especially in a broader population including those at high risk of complications from influenza[4][5].

Regulatory and Public Health Implications

The positive results from the CENTERSTONE study are expected to be discussed with regulatory authorities and public health organizations to integrate Xofluza into influenza pandemic preparedness strategies. This could lead to broader recommendations and guidelines for its use, further enhancing its market position[4][5].

Key Takeaways

• Clinical Efficacy: Xofluza has demonstrated significant efficacy in reducing the transmission of influenza within households and preventing infection post-exposure.
• Market Potential: Despite current modest sales, the new label expansion and potential approval for younger patients could significantly boost Xofluza’s market performance.
• Public Health Impact: Xofluza’s ability to reduce influenza transmission can improve health outcomes at both individual and community levels.
• Safety: The drug has been well-tolerated in clinical trials, making it a safe option for a wide range of patients.

FAQs

What is the mechanism of action of Xofluza?

Xofluza works by inhibiting the cap-dependent endonuclease protein, which is essential for the replication of influenza viruses.

What are the current indications for Xofluza?

Xofluza is approved for treating uncomplicated influenza types A and B, and for post-exposure prophylaxis in people aged 12 years and older.

What were the key findings of the CENTERSTONE study?

The CENTERSTONE study showed that a single dose of Xofluza significantly reduced the transmission of influenza from an infected person to their household contacts.

Why has Xofluza not achieved blockbuster sales yet?

Xofluza's sales have been modest due to competition from cheap generics of its predecessor, Tamiflu, and limited approval for younger patients.

What are the future market projections for Xofluza?

The recent positive clinical trial results and potential expansion to younger patients are expected to enhance Xofluza’s market performance and public health impact.

Sources

1. Roche reports positive data from Phase III influenza treatment trial. Clinical Trials Arena.
2. Roche's Xofluza wins FDA nod to prevent flu but hits a snag with bid to reach younger patients. Fierce Pharma.
3. 3rd Quarter of Fiscal 2023 Financial Results. Shionogi Inc.
4. Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. Roche.
5. Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses. BioSpace.