Our Focus
Amplyx is developing treatments to defeat life-threatening diseases in immunocompromised patients, and keep them on the path to their cure.
Every day, people undergo medical interventions that can severely compromise the immune system. Whether jeopardized by aggressive drugs to fight cancer, immune-suppressing drugs to prevent rejection after an organ transplant, or simply a hospital stay to treat a critical illness, the immune system of a patient will be stressed.
When the immune system is compromised, individuals who are already fighting for their lives become susceptible to other diseases that may be even more life-threatening than their original diagnosis. Opportunistic fungal pathogens can grow, and long-latent viruses can erupt, forcing an unexpected detour off the patient’s recovery path.
At Amplyx, we are developing therapies to defeat the life-threatening diseases caused by life-saving therapies.
Amplyx Pharmaceuticals is addressing this challenge by developing treatments for patients who are immunocompromised and impacted by fungal infections caused by pathogens such as Candida, Aspergillus and rare molds, as well as patients at risk for nephropathy and hemorrhagic cystitis caused by the BK virus.
Life-Threatening Fungal Diseases
Over 600,000 cases of invasive fungal infections occur annually, caused primarily by Candida and Aspergillus, with mortality rates ranging from 50-80%.
People with compromised immune systems are at highest risk from these invasive life-threatening infections, particularly those who undergo treatment for cancer or are otherwise critically ill.
Currently, there are only three classes of antifungal drugs commercially available for these invasive infections – polyenes, azoles and echinocandins – and all have significant limitations.
Treatment failures may occur when the antifungal drug simply does not work against the specific pathogen, or the pathogen has become drug resistant. For example, the new strain Candida auris is resistant to all available antifungal drugs.
Compounding the problem, available antifungal drugs may cause kidney, liver and other toxicities, or serious drug-drug interactions with the medicines that are important to treat a patient’s underlying disease.
Facing high mortality and morbidity, patients have a critical need for new, safe and effective antifungal therapies. Yet, no new class of anti-fungal agent has been launched for the last two decades.
Candidemia and Invasive Candidiasis
According to the US Centers for Disease Control and Prevention, Candida is a yeast that can cause infection, but normally lives on the skin and inside the body without causing problems. If it grows out of control or enters deep into the body – such as in the bloodstream (candidemia) or internal organs (invasive candidiasis) – it can be life-threatening. Some types of Candida are resistant to antifungal drugs. Notably, the emerging strain Candida auris is on the rise, and is resistant to all antifungal drugs currently available. Outbreaks of Candida auris have occurred in healthcare settings, including hospitals and long-term care facilities.
Aspergillosis
Aspergillosis is a disease caused by Aspergillus, a common mold that people are exposed to every day. For people with compromised immune systems, aspergillosis can be a life-threatening illness, causing invasive lung infections which may spread to other organs such as the brain and skin, and bone.
Invasive aspergillosis can cause death in more than half of infected patients with compromised immune systems. Some strains are resistant to all azole antifungal medications.
The United States Centers for Disease Control and Prevention now recognizes drug resistant Candida and Aspergillus as urgent and serious threats in its 2019 Antibiotic Resistance Threats Report.
BK Virus
What is BKV?
The BK virus is a ubiquitous virus with a worldwide prevalence of 75-90%. Following initial infection, the virus remains latent in most people, but reactivation may occur in transplant patients who are immunocompromised from immunosuppressive therapy used to prevent transplant rejection.
BKV-Associated Nephropathy
In kidney transplant recipients, reactivation of the virus can lead to BK viremia, which can result in BKV-associated nephropathy – a leading cause of irreversible kidney damage and graft failure. The current standard of care is to reduce immunosuppression, but that carries significant risk of active immune system rejection of the life-saving organ.
BKV-Associated Hemorrhagic Cystitis
Reactivation of BK virus in people who have undergone bone marrow transplantation may cause BKV-associated hemorrhagic cystitis, an intensely painful condition that can last weeks to months and cause prolonged hospitalizations. Current care for hemorrhagic cystitis is generally supportive, including narcotic analgesics, hydration and diuresis. Many patients also require bladder irrigation, clot evacuation, blood transfusion, stenting and nephrostomy.
There are currently no treatments for BKV diseases.