Advancing novel therapeutic solutions
for life-threatening infections.
Our Focus
Amplyx Pharmaceuticals is 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.
Patients undergoing chemotherapy and other immunosuppressive treatments end up with compromised immune systems. This makes them susceptible to a new disease—invasive fungal infections. By treating their underlying condition, patients are now open to a new life-threatening disease.
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 which have developed resistance.
Amplyx is advancing a novel small-molecule therapy, APX001, in clinical development. Intravenous and oral formulations of APX001 have been evaluated in a Phase 1 clinical program, with Phase 2 clinical trials in invasive fungal infections planned for initiation in 2018.
About Us
Amplyx was founded on a mission to develop a new class of antifungal medicine that would overcome the severe limitations of today’s therapy options.
Amplyx has a proven management team and strong financial position, having raised a total of $118.5 million in venture capital and received more than $10 million in grants from the National Institutes of Health. Amplyx initiated clinical trials in 2016 for its novel drug candidate APX001.
The company is based in San Diego, California.
“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, Business Development & Administration
Elizabeth Gordon, Ph.D.
Vice President, Regulatory Affairs
Pamela Wedel
Vice President, Clinical Operations
News
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
Amplyx Pharmaceuticals Demonstrates APX001 has Potent Activity Against Deadly Multidrug-Resistant Candida Species
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
Amplyx Pharmaceuticals Announces Appointment of CFO and Presentation at the J.P. Morgan 36th Annual 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
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.