Potential COVID-19 treatment to wrap up Phase III trial

By Jenni Spinner

- Last updated on GMT

(Darryl Fonseka/iStock via Getty Images Plus)
(Darryl Fonseka/iStock via Getty Images Plus)

Related tags COVID-19 Coronavirus Phase 3 Oral drug delivery Clinical trials

Appili Therapeutics reports it has enrolled the last patient for its Phase III study of Avigan/Reeqonus (favipiravir), developed in alliance with AiPharma.

Pharmaceutical company Appili Therapeutics has reported the enrollment of the last patient in its Phase III clinical trial to investigate the effectiveness of oral drug Avigan/Reeqonus (favipiravir) to treat COVID-19. The firm recently entered a strategic alliance agreement with AiPharma to develop and advance the drug.

Alessandro Gadotti, CEO of AiPharma, spoke with Outsourcing-Pharma about Avigan/Reeqonus, how it works, and the expected delivery date for data from the study.

OSP: Could you please share a short description of AiPharma—who you are, your focus on infectious diseases, and any notable accomplishments you’ve made in recent years our readers should know about?

AG: AiPharma is a biopharmaceutical company focused on discovering, developing, and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. In October 2020, AiPharma joined a global consortium of pharmaceutical, manufacturing, and distribution leaders to advance oral antiviral Avigan/Reeqonus for COVID-19. As part of the consortium, AiPharma commercializes all formulations of favipiravir, a broad spectrum oral antiviral drug that targets COVID-19 and 11 other infectious diseases.

AiPharma recently announced a strategic alliance and swap agreement with Appili Therapeutics to accelerate the global development of the oral antiviral medicine Avigan/Reeqonus for the potential treatment of COVID-19 and other infectious diseases. They also announced that the last patient enrolled in their Phase III clinical trial for the drug, with Phase III data is expected to be released in the upcoming months.

If approved, it would be one of the first outpatient antiviral treatments for mild-to-moderate COVID-19 in the US market. Of note, Avigan/Reeqonus (favipiravir) has already treated 1.5m patients and has been purchased under compassionate use Mexico, India, Malaysia, Thailand, Indonesia, Japan, UK, United Arab Emirates, Greece, Hungary, and Saudi Arabia.

The company is also advancing a diverse range of antivirals. Led by a proven management team, AiPharma is at the epicenter of the global fight against infectious and viral diseases.

OSP: Please share your perspective on how discovery and research of potential COVID-19 treatments have progressed in the time since the virus landed on us.

Alessandro Gadotti, CEO of AiPharma

AG: We’ve made great strides in COVID-19 treatment and prevention in a short period of time, but there’s no question there is more work to be done. We are at a critical moment in this pandemic, and antivirals are key to implementing a long-term solution that eases the burden on the global healthcare system.

Currently, we are using a “last line of defense” strategy – treating patients after they are hospitalized with severe illness, which squanders valuable treatment windows and leaves immune-compromised individuals and underserved populations especially vulnerable as well as putting immense pressure on health care systems.

Once approved, Avigan/Reeqonus will provide a “first line of defense” strategy in which those showing COVID-19 mild to moderate symptoms can be treated earlier in the disease course which means that, and fewer people will require treatment in hospitals. This strategy will allow us to turn the dial on the three key metrics the virus is measured against infection, hospitalization, and deaths.

Antivirals are efficient and cost-effective medicines that can limit the dissemination and severity of COVID-19 and physicians have been asking for them since the start of the pandemic. They allow people to recover quicker and return to their normal daily functions and obligations such as work and spending time with loved ones.

Avigan/Reeqonus has received emergency use authorization in a number of markets as a treatment for COVID-19, including Mexico, India, Indonesia, Thailand, United Arab Emirates, and Malaysia. Additionally, many other countries have purchased the drug under compassionate use programs, including the UK, Greece, Hungary, and Saudi Arabia. 

OSP: How does the Avigan/Reeqonus treatment improve upon the other therapies being explored, and given tentative nods by various global agencies?

AG: Avigan/Reeqonus, unlike other antivirals being tested, has a 10-year shelf life at room temperature, can be administered orally and was the first treatment approved for mild-to-moderate COVID-19 in global markets. It has a well-known safety profile based on extensive study in over 40 clinical trials, and more recently, from emergency use for the treatment of COVID-19 around the world.

The global manufacturing infrastructure that is needed to produce, manufacture, and distribute Avigan/Reeqonus is already established. This allows a supply chain and stockpile to be maintained, which is a key goal of governments as they look to the future of pandemic preparedness.

Moreover, our consortium of partners is committed to ensuring Avigan/Reeqonus is equitably accessible to all communities, especially those most impacted by COVID-19. Finally, based on its mechanism of action and broad spectrum of activity, it has the potential to address COVID variants that might be resistant to current vaccines and therapies.

OSP: Do you have anything to add—about your company, the treatment at the center of the PRESECO trial, the general field of COVID-19 treatments, etc.?

AG: To prepare for future pandemic threats, governments must have a reserve of antivirals they can immediately access and deploy to fight the virus in the community, which will reduce transmission and ease pressures on providers and healthcare systems. With its 10-year shelf life, Avigan/Reeqonus can potentially become a key tool in pandemic preparedness for governments looking to stockpile.

Our goal is to develop and make available Avigan as a new medical countermeasure for COVID-19 and other emerging viruses.  Of note, the Japanese government has already placed an order for 65 million tablets as they look to stockpile for any future outbreaks.

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