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Patients
undergoing immunosuppressive treatments, like chemotherapy, end up with
compromised immune systems. As a consequence invasive fungal infections have
emerged as a significant problem among cancer patients, causing both morbidity
and mortality. In fact, at least 40-50% of fatal infections are caused by
fungi. However, existing therapies for these infections are extremely limited.
They are restricted by drug interactions, toxic side effects, ineffective
against more potent fungi that have developed resistance, and not to mention
expensive.
In order to
overcome these limitations, the San-Diego-based startup Amplyx Pharmaceuticals
is developing novel, broad-spectrum antifungal agents for the treatment of
life-threatening invasive fungal infections. Their small-molecule therapy,
APX001, inhibit the Gwt1 fungal enzyme, and therefore maintain its activity
against fungal organisms that have developed resistance to other drug classes.
The drug candidate has been extensively evaluated in preclinical studies and
have demonstrated broad-spectrum activity against infections caused by Candida,
Aspergillus, as well as rare and hard-to-treat molds. In addition, the startup
is developing both an IV and oral formulation of the drug to address the need
for hospital administration, as well as continued dosage after hospital
discharge.
Increased
awareness among physicians and biotechnological advances have had considerable
impact on improving diagnosis of invasive fungal infections. However, it remain
difficult to manage, and there is an urgent need for improved treatment. APX001
has the potential to be used as a front line agent, either alone or in
combination with existing antifungal drugs. It could overcome limitations
associated with existing therapies, and significantly improve treatment
efficacy. Annually, there are over 600,000 cases of invasive fungal infections
due to Candida, Aspergillus and rare molds, and the work by Amplyx could give
new hope to every single one of these patients.
APX001 is
expected to enter clinical development this year, and Amplyx has raised over $50
million in venture capital with investors including 3x5 Special Opportunity Fund, Biomed Ventures, New Enterprise Associates, RiverVest and Tech Coast Angels. The startup has also received more than $10 million in grants from the
National Institutes of Health to support its drug discovery and development
efforts. The startup’s research operations is located at Johnson & Johnson
Innovation, JLABS.
The drug
candidate has been granted Qualified Infectious Product (QIDP) by FDA, a
designation established to encourage pharmaceutical companies to develop new
antimicrobial drugs to treat serious and life-threatening infections. The designation
provide significant incentives for the development of the drug, including
priority FDA review, eligibility for Fast Track designation and a five-year
extension of marketing exclusivity.
