바카라보라

바카라보라 Therapeutics, a subsidiary of 바카라보라 Pharmaceutical, is diversifying formulations and indications for Type 2 diabetes treatment Envlo (active ingredient: enavogliflozin). Envlo, 바카라보라 Pharmaceutical's 36th domestic new drug, introduced an SGLT-2 inhibitor-based diabetes treatment to the market in July.

On September 8th, the Ministry of Food and Drug Safety (MFDS) in South Korea approved 바카라보라 Therapeutics' Phase 1 clinical trial plan (Investigational New Drug, IND) for 'DWRX2008 (development code name: Envlo),' a topical medication featuring enavogliflozin as its main ingredient.

This clinical trial will involve healthy Korean and Western individuals in a parallel design, utilizing random allocation, placebo control, and stepwise increasing instillation studies to assess DWRX2008's safety, local tolerability, and pharmacokinetics. The study aims to include 56 international patients, with a focus on 48 South Korean patients. The clinical trial is scheduled to take place at Bundang Seoul National University Hospital, with completion expected by April 2024.

This groundbreaking clinical trial diverges from the conventional development of oral SGLT-2 inhibitor-based formulations by exploring the potential of a topical medication. Notably, among the 728 approved SGLT-2 inhibitor formulations in the country, there are currently no non-oral options available.

Furthermore, DWRX2008 has gained approval for treating eye complications in Type 2 diabetes patients, such as non-proliferative diabetic retinopathy and diabetic macular edema. This marks a significant enhancement for Envlo, previously approved as an adjunct to diet and exercise therapy for improving blood sugar control in Type 2 diabetes patients.

SGLT-2 inhibitors operate by preventing glucose reabsorption in the kidneys, leading to increased glucose excretion and reduced blood sugar levels. However, it remains undisclosed whether DWRX2008 can alleviate diabetes symptoms and reduce eye complications in Type 2 diabetes patients, or if it has a direct impact on these complications.

Until recently, 바카라보라 Pharmaceutical had been supplying Envlo as a generic medication to its subsidiaries, including 바카라보라 Bio and Hanall Biopharma, as part of its supply chain diversification strategy. While there have been successful cases, 바카라보라 had not previously pursued formulation and indication changes of the kind now being explored with DWRX2008.

Established in 2019, 바카라보라 Therapeutics, a subsidiary of 바카라보라 Pharmaceutical, focuses on new drug development and drug delivery platform technologies. Their scope includes precision medicine-based anticancer drug development, PROTAC (Proteolysis Targeting Chimeras) development, Microneedle Platform Technology, improved drug research, contract research organization, and contract development organization (CRO&CDO) services, as well as innovative animal pharmaceutical development.

A representative from 바카라보라 Pharmaceutical informed HitNews that 바카라보라 Therapeutics is actively researching ways to expand the use of ingredients developed by 바카라보라 Pharmaceutical, including DWRX2008, through their expertise in drug research and formulation. They noted that while Phase 1 clinical trial approval for DWRX2008 has been secured, other ongoing research initiatives are not yet ready for disclosure.