Matinas BioPharma announced that its lead antibacterial candidate has been designed as a Qualified Infectious Disease Product by the FDA for the treatment of nontuberculous mycobacterium infections.
The FDA's designation makes the reformulation of the broad-spectrum antibiotic agent amikacin eligible for priority review, Fast Track designation, and eligibility for 5 additional years of marketing exclusivity following FDA approval. The candidate uses the company's flagship cochleate lipid-crystal nanoparticle drug delivery technology to achieve targeted drug delivery, enabling higher doses and fewer side effects.
"Treatment of non-tuberculous mycobacterium, or NTM, infections is difficult given resistance to many antibacterial drugs. NTM can lead to chronic infections requiring treatment regimens for a year or longer under current guidelines, and there is growing concern that resistant NTM may be responsible for a disproportionate share of clinical infections," said Matinas CEO Roelof Rongen in a statement. "The broad spectrum antibiotic, amikacin, has shown very little microbial resistance but its severe side effects and intravenous delivery make it impractical and unsafe for the long-term therapy required to resolve these very serious and often life-threatening infections."
Matinas co-founder and chief business officer Jerome Jabbour told FierceDrugDelivery that the platform amounts to a method of "trapping an impurity inside of a solid" so that it can be transferred to site of infection following oral administration.
The nanoparticles consist of the drug, or payload, sealed within a rolled-up soy-based lipid bilayer sheet, to which calcium has been added.
Following administration, the nanoparticles are engulfed by macrophages within the GI tract. Then, the bilayer unfolds within the macrophage, releasing the drugs inside its walls. This occurs because the concentration of calcium is lower inside the macrophage than it is outside of the macrophage, Jabbour said.
The macrophage then carries and releases the drug at the site of infection, while preventing exposure to the body along the way, resulting in targeted delivery and fewer side effects, Jabbour said.
Matinas' lead antifungal candidate earned FDA's fast track designation in August following classification as a Qualified Infectious Disease Product. It is being developed with the assistance of the NIH's National Institute of Allergy and Infectious Disease, which is funding an ongoing Phase IIa clinical trial of the medication. Data for that candidate is expected in Q1 2016.
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