Advancing novel therapeutic solutions
for life-threatening infections.
Our Focus
Globally, an estimated 1.5 million people die every year from invasive fungal infections. Patients with a weakened immune system, such as those undergoing chemotherapy and other immunosuppressive treatments, are at particular risk.
Yet, existing therapies for invasive fungal infections are extremely limited on many fronts—they’re difficult to administer, can have toxic side effects and are ineffective against more potent fungi. In addition, many fungal strains, including some of the most dangerous, have developed resistance to current therapeutic options.
Amplyx is answering the need for innovative therapies to fight invasive fungal infections. Our novel small-molecule therapy, APX001, is in clinical development to treat today’s deadliest fungal pathogens, including Candida auris, which the Centers for Disease Control has classified as a “catastrophic threat.” Intravenous and oral formulations of APX001 have been evaluated in a Phase 1 clinical program, with Phase 2 clinical trials in invasive fungal infections currently underway.
WHEN A FUNGAL INFECTION IS SCARIER THAN CANCER
Blake Gauss was diagnosed with leukemia at 2 years old. But it was a deadly fungal infection that nearly took his life. Read his story here.
About Us
Amplyx was founded on a mission to save lives by developing a new class of antifungal medicine that would overcome the severe limitations of today’s therapeutic options. We are developing first-in-class products for the treatment of life-threatening infections, with a near-term focus on deadly fungal pathogens in vulnerable, immune-compromised patients. Amplyx’s leadership has extensive experience developing drugs to treat infectious diseases, as well as treatments for rare conditions. To support its development efforts thus far, we have received over $10 million in National Institutes of Health grants and have raised a total of $118.5 million in venture capital funding.
The company is based in San Diego, California.
For more information on Amplyx, please view our fact sheet.
“There hasn’t been a new class of antifungal drug approved since 2001, and many existing antifungal agents are difficult to use, poorly tolerated or ineffective due to the rise of drug-resistant strains.”
— Mike Grey,
Executive Chairman, Amplyx Pharmaceuticals
Management
Ciara Kennedy, Ph.D.
President and CEO
Mike Hodges, M.D.
Chief Medical Officer
Karen Joy Shaw, Ph.D.
Chief Scientific Officer
Alan Fuhrman
Chief Financial Officer
Paul Bien
Vice President, Program Management & Operations
Susan Dubé
Vice President, Corporate Development
Elizabeth Gordon, Ph.D.
Vice President, Regulatory Affairs
Pamela Wedel
Vice President, Clinical Operations
News
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Amplyx Doses First Patient in Phase 2 Trial of APX001 in Patients with Candida Infection
Amplyx Announces Presentations on APX001 at American Society for Microbiology Microbe 2018 and the 20th Symposium on Infections in the Immunocompromised Host
Amplyx Pharmaceuticals to Participate in BIO International Convention Panel and Present at Jefferies Global Healthcare Conference
Press Release Archive | Poster Archive | Manuscript Archive
If you’re a member of the media and would like to reach Amplyx, please contact:
Heidi Chokeir, Ph.D.
Senior Vice President, Canale Communications
(619) 849-5377
heidi@canalecomm.com
APX001
Lead candidate APX001, in Phase 2 clinical development, is a broad-spectrum antifungal agent that has shown activity in vitro and in immunocompromised animal models of infection against pathogens of highest mortality, including Candida, Aspergillus and rare molds. One of the first antifungals developed in more than a decade, APX001 has a novel mechanism of action with robust activity against drug-resistant fungi, yeasts and molds. Importantly, APX001 can be delivered in both oral and intravenous formulations, both of which have been safe and well tolerated in Phase 1 studies. The APX001 development program is supported by clinical and preclinical data that are generally predictive of late-stage clinical success for anti-infective drugs. APX001 has received FDA’s Orphan Drug designation in six different fungal infections and is classified as a Qualified Infectious Disease Product in the United States, enabling expedited regulatory review and additional extended marketing exclusivity.
For more information on APX001, please view our fact sheet.
Clinical Trials
PHASE 2
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non-Neutropenic Patients with Candidemia, with or without Invasive Candidiasis, Inclusive of Patients with Suspected Resistance to Standard of Care Antifungal Treatment
PHASE 1B
An Open-Label, Multicenter Study to Determine the Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia with Neutropenia
PHASE 1
A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001
PHASE 1
A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo Controlled Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
For additional information, please see Amplyx Clinical Trials.
Expanded Access
Amplyx is committed to developing safe and effective first-in-class products for the treatment of life-threatening infections, with a near-term focus on deadly fungal pathogens in vulnerable, immunocompromised patients. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Amplyx believes that the most appropriate mechanism to access investigational therapies is in the context of a clinical trial. We recognize, however, that there are circumstances that may arise that prohibit a patient’s participation in a clinical trial. At this time, Amplyx’s Expanded Access program is currently under development. We will update this page with additional information on this program once it is available. If you have any questions, please contact medinfo@amplyx.com.
Careers
Amplyx is driven by a mission to develop the best treatment for patients with life-threatening fungal infections. Our growing team brings a long history of drug development experience, effective company leadership and spirited collaboration. As we expand, we continue to welcome passionate and talented individuals who share our desire to create new possibilities in medicine.
Amplyx offers a competitive compensation package and a rewarding work environment that fosters innovation. We invite you to explore our career opportunities. If you don’t find a perfect job match on our website, but think Amplyx may be the right place for you, please submit your resume to careers@amplyx.com.