As the year draws to a close, attention is turning to the clinical results of Hanol Biopharma's autoimmune disease treatment 'Imeroprobat,' SK Biopharm's epilepsy drug 'Opacalim,' and Olix's hair loss treatment 'OLX104C.' Market analysts predict that these clinical events could revive the previously stagnant investment sentiment in the pharmaceutical and biotech sectors.
Hanol Biopharma, a subsidiary of Daewoong Pharmaceutical, announced on November 10 that its global partner Immunovant met the primary endpoint in a Phase 2b trial of Imeroprobat (IMVT-1402) for patients with refractory rheumatoid arthritis (D2T RA).
The trial targeted patients who had not responded to at least two different targeted therapies. After administering 600 mg for 16 weeks, patients who showed a response were divided into groups receiving 600 mg, 300 mg, or a placebo for an additional 12 weeks.
In the 28-week evaluation, the ACR20 response rate (percentage of patients with over 20% improvement in symptoms) for the 600 mg group was 92.5%, significantly higher than the placebo group (75.6%) by 16.9 percentage points, with statistical significance achieved. The ACR50 and ACR70 response rates were 80% and 52.5%, respectively. Among patients who had used both JAK and TNF inhibitors, the ACR20 response rate was 92%. No serious adverse events were reported. However, the secondary endpoints measuring disease activity (CDAI and SDAI) did not show significant differences compared to the placebo group, and the 300 mg group also did not differ from the placebo.
Immunovant plans to discuss further development plans with the U.S. Food and Drug Administration (FDA) by the end of the year. Key results for trials on Graves' disease and myasthenia gravis are expected in 2027, while results for chronic inflammatory demyelinating polyneuropathy (CIDP) are anticipated in 2028.
SK Biopharm's epilepsy drug candidate 'Opacalim' has emerged as a variable following a deal with U.S. company Biohaven worth up to $795 million (approximately 1.1 trillion won) announced in August. In September, the FDA notified SK Biopharm of a partial clinical hold on the Phase 2/3 trials 'RISE2' and 'RISE3' due to nonclinical toxicity findings in rodents. Consequently, new patient enrollment for RISE2 has been halted. The technology transfer agreement is still under review by the U.S. antitrust authorities (HSR), and no upfront payment has been made yet.
Both companies believe that the toxicity findings are limited to rodents and are unlikely to affect humans. The RISE3 trial, which has completed patient enrollment, is proceeding normally with the goal of announcing top-line results by the end of the year.
Yoo Chang-ho, head of strategy at SK Biopharm, stated during a conference call in September, "Discussions are ongoing between the two companies to proceed with the closing of the licensing agreement once the clinical hold issue is sufficiently resolved."
Olix is preparing to release data from its Phase 1b trial of the male pattern hair loss treatment 'OLX104C' in Australia. OLX104C is an RNA interference (RNAi) therapy that reduces the expression of androgen receptors (AR), a major cause of hair loss, administered via injection to the scalp every four weeks. The company has completed the last patient dosing and follow-up for the Phase 1b trial. A Phase 2a trial, which will increase the number of patients by adding New Zealand, is planned to begin dosing the first patient by the end of the year. However, the market anticipates that the data from the Phase 1b trial may focus on safety and tolerability.
An industry insider noted, "The year-end clinical results will not only gauge the value of individual companies' pipelines but also serve as a litmus test for the recovery of investment sentiment in the domestic biotech sector."
* This article has been translated by AI.
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