[E-Daily Reporter NA EUN-KYUNG ] The Parkinson’s disease treatment market has been facing the same limitations for decades. Currently available drugs only alleviate symptoms; they do not halt the progression of the disease itself.

As a result, global pharmaceutical companies have been attempting to develop disease-modifying therapies (DMTs) but have yet to achieve significant results. Glaseum interprets the root cause of these failures differently. It argues that the problem lies not with alpha-synuclein but with cellular function.

The Parkinson’s barrier that neither Roche nor Biogen could overcome

Parkinson’s disease is a representative degenerative brain disorder caused by the gradual death of dopamine-producing neurons in the brain. Currently prescribed medications, such as levodopa and dopamine agonists, are limited to replenishing deficient dopamine or managing symptoms.

As a result, global pharmaceutical companies have rushed to develop disease-modifying therapies (DMTs) that slow the progression of the disease itself. A prime target has been alpha-synuclein. It is known that in the brains of Parkinson’s patients, alpha-synuclein aggregates abnormally to form Lewy bodies.

Roche and Biogen each took on the challenge of an alpha-synuclein removal strategy by developing prasinezumab and cinepanemab, respectively. However, Biogen halted development following a failed Phase 2 clinical trial. Roche also failed to meet the primary endpoints in two mid-stage clinical trials. Even global pharmaceutical companies have repeatedly failed in their efforts to develop DMTs for Parkinson’s disease.

Glaseum posed a different question here. The company focused on the possibility that alpha-synuclein itself is not the root cause of the disease, but rather a result of cellular dysfunction.

Yoo Sang-gu, CEO of Glaseum, explained, “We thought that since alpha-synuclein accumulates, removing it would improve the disease, but the actual clinical results did not support that. Simply removing the accumulation of ‘garbage’ does not restore the cells to health.”

Glaseum turned its attention to autophagy. Autophagy is known as a cellular cleanup system that removes damaged proteins and waste products from inside cells. Glaseum believes that the problem in Parkinson’s disease patients is not a single specific protein, but rather a breakdown in the cell’s cleansing function itself. The logic is that if cells function normally, alpha-synuclein can also be naturally eliminated.

Butiglabridin is a compound developed from this perspective. Glaseum confirmed its autophagy-activating effects while developing butiglabridin as a treatment for obesity and subsequently expanded its indication to Parkinson’s disease.
Targeting

Early-Stage Patients… “We Will Delay the Start of Levodopa Treatment”

Glaseum’s focus on

early-stage patients

stems from the same rationale. Glaseum is currently preparing for a Phase 2b clinical trial for Parkinson’s disease. The trial participants were selected from patients in relatively early stages following diagnosis. CEO Yoo believes that therapeutic effects can be expected in early-stage patients who still retain some cellular function, rather than in patients who have already lost a significant number of neurons.

The treatment goal is also clear: not to replace levodopa, but to delay its use as long as possible. In fact, while levodopa is currently the most effective treatment for Parkinson’s disease, long-term use is associated with side effects such as dyskinesia. Therefore, it is beneficial for patients to start levodopa treatment as late as possible.

In a Phase 2a clinical trial conducted last year, Glaseum confirmed the potential for improving motor function in patients with early-stage Parkinson’s disease. Based on these results, Glaseum plans to verify the drug’s ability to slow disease progression through follow-up clinical trials.

Glaseum submitted an Investigational New Drug (IND) application for a Phase 2b clinical trial of butiglabridin to the Ministry of Food and Drug Safety (MFDS) in late May and is currently awaiting approval from the MFDS. For the Phase 2b trial—for which approval is expected to be finalized in the second half of this year—Glaseum plans to increase the number of patients to over 100 and conduct the trial for approximately one year.

CEO Yoo stated, “We are not a company that eliminates alpha-synuclein; we are a company that promotes cellular health,” adding, “Our goal is to change the approach to treating Parkinson’s disease.”