Pharmako Biotechnologies outlines clinical trial plans and new collaborations following TGA site approval

The company specialises in lipid-based delivery systems that help enhance fat-soluble nutrients absorption in the body. Its solutions ranging from pre-mixes, capsules, liquids, and powders are used in the nutraceutical, pharmaceutical, and cosmeceutical industries. 

Under the guidance of the TGA, Pharmako is the first licensed manufacturer in Australia producing Active Pharmaceutical Ingredients (APIs) with advanced dispersion and solubility technologies.

Following this, Pharmako is planning a clinical trial on a new microbiome product.

According to Pharmako’s technical director and co-founder George Kokkinis, “It's not a typical probiotic or prebiotic, which typically have stability issues affecting their efficacy,​

“We are using nano technology to shift the microbiome, allow the good bacteria to proliferate in a way which affects certain blood markers and liver health related markers positively​.”

It is a product said to be made from natural biomaterials with well-defined nanoarchitecture, reinforced with dietary fibres that can positively affect the microbiome, blood glucose levels, liver weight, liver enzymes, and body weight.

The product was studied in animal models previously, which Kokkinis said was found to reduce negative chemical markers in the liver, reduce glucose levels, and helps with weight loss.

The company is planning to conduct human clinical trials in three stages over the next few months, started with 15 to 20 subjects, and increasing to 300 subjects in the final stage.

“Hence, our (TGA) license to make clinical material for clinical trials was important for us so we can control what we create and how it's used in the studies​,” Kokkinis added.

Other studies in the pipeline include a trial on its HydroCurc (water dispersible curcumin) effect on Brain Derived Neurotrophic Factor (BDNF), as well as its Levagen+ (cold water dispersion of palmitoylethanolamide) effect on menstrual pain, peripheral neuropathy and upper respiratory tract infections.

Process of approval and markets​

Pharmako first applied for the TGA licence in July 2020.

According to Kokkinis, the dispersion technology is relatively new and there were not many companies in this space.

In Australia, Pharmako is the only company doing dispersion technologies at a commercial level, while there were many research institutes and universities doing these in a research setting.

Hence, there was a lot of explaining their work at the start: “We had to get TGA to understand what we do, help them understand that we are increasing absorption of functional ingredients by creating dispersions of poorly absorbed materials​.

“Once they understood and we were considered for a license, and now TGA-approved, it allows us to make materials that could be used in clinical trials as well​.”

TGA is recognised outside of Australia by other governments around the world, and is an equivalent to the US FDA endorsement.

Pharmako works with various companies worldwide including US’s Walgreens which uses Pharmako’s AquaCelle Q10 in its CoQ10 soft gel supplement, which gives CoQ10 at least three times better absorption.

US-based Schiff’s omega-3 fish oil supplement also uses AquaCelle which increases absorption by six times. Beyond absorption, “Aquacell can reduce the fishy aftertaste that you typically get in fish oil capsules​,” Kokkinis said.

In Norway, Zinzino uses AquaCelle in its omega-3 product, and more recently, GNC in South Korea launched an omega-3 supplement containing AquaCelle.

Pharmako is currently working with a European company to launch an effervescent tablet with HydroCurc, a sleep formula with its lavender oil powder (a micro droplet forming dry powder) in Australia, a product using its AquaCelle Krill oil (highly absorbable krill oil) in Indonesia, and with a Malaysian company using its Compressible Powdered Oil (CPO) technology to convert oils into dry, dispersible powders.

The company also has several studies pending publication, include its AquaCelle’s ability to increase astaxanthin absorption, its HydroCurc verses a placebo in reducing joint pain, and the effectiveness of orally-dosed Palmitoylethanolamide (PEA) compared to ibuprofen for reducing pain severity and duration of headaches in healthy participants.

Besides its award-winning delivery systems, Pharmako also produces Levagen+ for its sister company in US (Gencor).

AquaCelle Q10 formulation won the NutraIngredients-USA​ ‘Ingredient of the Year- Healthy Ageing’ award in 2020.

HydroCurc formulation won the NutraIngredients-Asia​ ‘Ingredient of the Year - Cognitive Function’ also in 2020. HydroCurc is a powder specifically designed to increase the bioavailability of curcuminoids.