[Asia Economy Reporter Hyunseok Yoo] HLB Pharmaceutical announced on the 15th that the results of the first large-scale domestic Phase 4 comparative clinical trial (TEAR study) of the spinocerebellar degeneration treatment ‘Citrellin’ were presented in poster format at the 2021 IC KMDS (Korean Movement Disorder Society) on the 10th.
Spinocerebellar degeneration is a disease caused by lesions in the cerebellum or spinal cord, leading to imbalance, gait disturbances, and speech disorders due to loss of muscle control in the limbs. Cerebellar ataxia is a rare and intractable disease, and currently, there is no standard treatment other than symptomatic therapies that suppress muscle rigidity and pain.
This Phase 4 clinical trial, conducted for the first time in Korea with 149 patients at eight large general hospitals including Korea University Guro Hospital, Samsung Seoul Hospital, and Seoul National University Hospital, was carried out to compare the efficacy and safety of Citrellin in patients with ataxia caused by spinocerebellar degeneration.
Comparing patients administered Citrellin and a placebo control group over 24 weeks, a significant improvement in ataxia was confirmed in the hereditary ataxia patient group treated with Citrellin compared to the placebo group.
With the efficacy and safety of Citrellin for spinocerebellar degeneration confirmed through this clinical result, it can now be considered as a new treatment option. Since Citrellin is an oral medication, it is expected to improve patient convenience in administration. Based on this clinical data, HLB Pharmaceutical plans to pursue insurance reimbursement listing.
Jae-hyung Park, CEO of HLB Pharmaceutical, said, “Through the first large-scale domestic clinical trial for spinocerebellar degeneration, we confirmed the efficacy of Citrellin,” and added, “HLB Pharmaceutical will continue to make efforts to expand research activities in the future.”
HLB Pharmaceutical, which has been showing significant annual sales growth due to increased prescriptions of specialty drugs such as chronic disease treatments, recorded cumulative sales of 45.2 billion KRW in the third quarter of this year, growing rapidly by more than 53% compared to 29.4 billion KRW in the same period last year.
In particular, following the license-out of long-acting injectable technology for obesity treatment using its independently developed long-acting injectable platform (SMEB®) to Humedix in August, the company’s credibility is also increasing as it achieves results in new drug development fields including Citrellin.
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