Company Overview
Founded in 2016
Drs. Heath and Krugner-Higby founded Plumb Pharmaceuticals. Inc. in 2016 to commercialize a novel, super extended drug release technology. The company is based in Madison, WI.
Advanced Quantload (AQL™) Platform
Plumb Pharmaceuticals, Inc. is commercializing a platform technology for super extended-release drug delivery. Medications developed using the company’s AQL technology have release rates measured in months, not days, enabling (for example) the provision of an entire course of antibiotics with a single injection, or continuous, longer-term relief from chronic pain and addiction.
Who We Are
Plumb Pharmaceuticals Inc. is a company dedicated to solving problems of medication compliance with extended-release formulations of FDA-approved drugs. Plumb Pharmaceuticals has developed a new delivery method to administer an already FDA-approved active ingredient. Our novel method to administer the FDA-approved active ingredient naltrexone will prevent individuals struggling with addiction from relapsing twice as long as current products such as Vivitrol® ($335M in sales 2019), which also uses naltrexone as its active ingredient.
What problem are we solving?
Opioid addiction is a major public health crisis that is becoming worse. 2.4 million Americans have been diagnosed with opioid dependence, and overdoses have increased, creating and economic burden of more than $78 billion/yr. Medications are the gold standard for treatment to help curb cravings and block opioid receptors. Plumb’s solution of Advanced Quantload™-Naltrexone will require dosing every 6 weeks reducing the opportunity for relapse between doses and Fewer Clinic Visits.
How are we solving it?
Our drug delivery platform utilizes lipid nanoparticles, also known as liposomes, which have been used in previously marketed formulations of important drugs. Our company has patented a novel method of forming the liposomes that encapsulates higher concentrations of material, we have a second patent on a method of drug loading into the liposomes that is complementary to the first patent. This system is called the Advanced Quantload (AQL™) method. The novel liposome formation method is used to encapsulate a compound that is then used to drive the drug into the liposome in the second step. The resulting liposome has a high concentration of drug within the particle, and then releases the drug very slowly after subcutaneous injection in animals.
What will the benefits be and for whom?
Vivitrol® causes injection pain and tissue damage. AQL™-Nal uses lipid nanoparticles that do not have painful byproducts. AQL™-Nal is administered by subcutaneous injection, a less invasive method. A 3-month naltrexone implant like the Prodetoxon® implant used in Russia also can cause inflammation. AQL™-Nal will be a longer lasting formulation, administered by the least invasive injection method and without inflammatory byproducts.
Why is this the right time for your product?
Opioid Use Disorder has changed in the last 10 years. Heroin, methamphetamine, and pills now contain the powerful synthetic opioid fentanyl and compounds like fentanyl. This contamination of illegal drugs with highly potent opioids has driven increases in overdose deaths and requires additional responses by the healthcare and recovery communities, both to provide blockade that will prevent overdose, and for Medication Assisted Therapy to address cravings and help promote abstinence in Opioid Use Disorder patients.
Milestones To Date
Early work at Plumb has achieved the following milestones critical to the development of AQL and its business:
Award Phase I SBIR grant to develop the liposome
formation technique and loading systems.
Validated the superiority of polyanions for pharmacokinetics in animal models,
Validated the use of the choice of cation as the
sacrificial leakage agent.
Obtained two issued patents for the liposomal
formation and indirect loading method
Awarded NIH I-Corp and WI SBIR Advance grants for
LEAN Star
What future problems will we tackle using our technology?
AQL™ is a platform technology that may also be used for several FDA-approved compounds to solve other problems around medication compliance. Mood-stabilizing medications used to treat psychosis or bipolar disorder have already been targets for extended-release formulation, and improved versions of these drugs may also be formulated using Plumb’s novel technology. Many drugs used for pain control may also be formulated using Plumb’s AQL™ platform technology, including most opioid drugs, as well as the most common drugs used to treat depression.