Daewoong Pharmaceutical has announced that it received investigational new drug (IND) approval for a Phase 1 clinical trial of its dissolvable microneedle patch designed for administering human growth hormone. This marks the first instance of IND approval for a dissolvable microneedle patch in the biopharmaceutical sector within Korea.
The Phase 1 clinical trial will evaluate the safety and pharmacokinetics of the dissolvable microneedle patch in comparison to Caretropin Cartridge, Daewoong's existing subcutaneous injection formulation. The primary objective is to determine if the patch can achieve a similar absorption rate to that of subcutaneous injections. Daewoong also intends to broaden the application of its human growth hormone product, which is currently approved for adult use, to include pediatric patients, with the goal of doubling its market share in the domestic growth hormone market.
Addressing Challenges in Growth Hormone Therapy
Human growth hormone is essential for treating conditions resulting from human growth hormone deficiency. Because these conditions often require long-term treatment, consistent administration of growth hormone is necessary. Traditionally, growth hormones have been administered via subcutaneous injections due to their large molecular size, which can cause discomfort and pain, potentially leading to reduced patient adherence and diminished treatment efficacy.
To overcome these challenges, Daewoong is developing a dissolvable microneedle patch for growth hormone delivery. The patch features approximately 100 tiny needles within a 1 cm x 1 cm area, designed for easy application to the skin, providing a more convenient and pain-free alternative to injections.
Clopam Technology and Product Stability
The microneedle patch incorporates Daewoong Therapeutics' patented Clopam technology. A significant hurdle in developing dissolvable microneedle patches is the potential for degradation due to moisture during manufacturing and distribution. Daewoong has implemented a pressurized drying process to ensure the drug is accurately positioned at the needle tip and remains sealed until application. This method ensures consistent drug delivery and maintains product stability, which the company anticipates will significantly improve patient compliance.
Impact on Pediatric Patients
This innovative delivery method is particularly significant for pediatric and adolescent patients with human growth hormone deficiency, who often experience anxiety related to needles. The development represents a promising advancement in treatment options for this patient population.
"Daewoong Pharmaceutical is committed to sustainable growth in the global healthcare market through its innovative pipeline," said Daewoong Pharmaceutical CEO Park Sung-soo. "We aim not only to develop new drugs but also to enhance patient compliance and convenience with breakthrough drug delivery platforms."
