Biotech company Likarda and VitalTE LifeSciences have entered into a new partnership to simplify the hormone replenishment therapy (HRT) process through Likarda's new drug delivery technology.
Core-Shell Spherification (CSS), is a novel approach to long-term testosterone pellet therapy which doesn't require surgical implantation — utilising hydrogel microencapsulated hormones to allow its slow and steady release.
The unmet need in HRT therapy
Hormone therapy can be used to treat a range of diseases associated with both the pituitary gland and the thyroid, while also combatting hypogonadism in men and low oestrogen levels in women.
Of the 200 million patients eligible for treatment worldwide, only a fraction currently seek treatment, as many of the products currently available on the market have a number of considerable shortcomings.
By optimising the hormone pellet implantation process, Likarda and VitalTE hope to offer patients a more effective form of HRT.
The product requires a minor surgical procedure, which means it's currently limited to specialised clinics.
To test CSS, the two companies are currently completing IND-enabling studies, which will be followed by a Phase I study in 2025.
Founder and CEO of VitalTE, Dr Charles Virden, commented: “Likarda has already generated formulations using its CSS technology that demonstrate the ability to encapsulate small molecules, and specifically for the slow release of testosterone,”
“Offering injectable extended-release hormones could reshape the market, improving the health and vitality of a broader range patients.”
“This partnership with VitalTE is an ideal match of technology and capabilities, combining CSS and our chemistry expertise with VitalTE’s deep understanding of extended-release HRT,” said Stella Vnook, CEO of Likarda and advisor to VitalTE.
“We have already demonstrated our ability to encapsulate a variety of biologics with CSS, including advanced therapies and antibodies. In addition to helping a vastly underserved community, we will also show the potential of our platform for small molecules."
The partners have attained US and international patent protection for the invention.
[Image credit: Likarda]