[Asia Economy Reporter Jang Hyowon] InventiGELAB (CEO Kim Juhee), a company specializing in microsphere long-acting injectable platforms and mRNA vaccine/gene therapy manufacturing platforms, announced on the 21st that it gave an oral presentation of the Phase 1/2 clinical trial results of its long-acting alopecia treatment pipeline IVL3001 (finasteride 1-month sustained release) at the World Congress for Hair Research 2022.


The World Congress for Hair Research 2022, held over four days from the 18th to the 21st in Melbourne, Australia, is the most prestigious conference where leading scholars, researchers, and pharmaceutical companies in the fields of hair growth and hair and scalp diseases gather to share the latest information and research findings.


At the conference, held for the first time in three years since COVID-19, InventiGELAB attracted global experts' attention by delivering the world's first oral presentation comparing the clinical trial results of finasteride long-acting injectable and the oral drug Propecia.


The Phase 1/2 clinical trials of IVL3001 conducted in Australia were jointly performed with Daewoong Pharmaceutical, a partner through a license-out agreement in 2020. The clinical trial, conducted from October 2021 to March 2022, aimed to compare the PK/PD indicators and safety of low, medium, and high doses of IVL3001 with the control drug Propecia tablets.


According to the study results, all dosage groups of IVL3001 maintained stable blood drug concentrations for the target maintenance period of one month, and the blood DHT concentration, a biological marker related to alopecia treatment, was effectively reduced. Notably, the common issue of initial burst release in long-acting injectables was absent. After injection, the drug maintained a stable blood concentration close to zero-order kinetics. This was demonstrated by maintaining levels below the peak blood concentration of the control drug Propecia, confirming its safety.


Through these results, the possibility of developing a product that can improve the safety and efficacy of IVL3001 was confirmed. Following the presentation, inquiries from academic circles and global pharmaceutical companies continued, and InventiGELAB plans to successfully advance global commercialization based on this interest.


Based on the successful Phase 1/2 clinical trial results of IVL3001, InventiGELAB plans to jointly conduct subsequent clinical studies, including Phase 3 trials, with Daewoong Pharmaceutical in 2023. Additionally, a dedicated manufacturing plant for IVL3001 will be completed at Withus Pharmaceutical's GMP site, and the world's first GMP plant equipped with InventiGELAB's ‘IVL-Drugfluidic’ production technology transfer is expected to begin operation soon.


Kim Juhee, CEO of InventiGELAB, said, “We are very pleased to present the successful clinical results of IVL3001, which applies the core platform technology of IVL-DrugFluidic, in front of global experts,” adding, “We will do our best to successfully complete the subsequent clinical trials and launch a product with improved safety, efficacy, and medication compliance.”



Meanwhile, according to market research firm Grand View Research, the global alopecia treatment market is expected to grow from 10 trillion KRW in 2021 to 20 trillion KRW by 2028. Male pattern hair loss treatments and alopecia areata treatments are analyzed as the main drivers of market growth.


This content was produced with the assistance of AI translation services.

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