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Oculis Holding AG's Phase 2 Trial Success: OCS-05 for Acute Optic Neuritis

$OCS
Form 6-K
Filed on: 2025-01-06
Source
Oculis Holding AG's Phase 2 Trial Success: OCS-05 for Acute Optic Neuritis

Key Information Extracted from the Financial Report (Form 6-K)

Company Overview

  • Registrant Name: Oculis Holding AG
  • Address: Bahnhofstrasse 7, CH-6300 Zug, Switzerland
  • Commission File Number: 001-41636
  • Report Date: January 6, 2025

Financial Highlights

  • Cash Position: Oculis reported approximately $105 to $110 million in cash, cash equivalents, and short-term investments at the beginning of the year (January 2025). This figure is preliminary and unaudited, subject to final results.

Clinical Trial Results

  • Trial Name: Phase 2 ACUITY trial evaluating OCS-05
  • Indication: Acute optic neuritis
  • Key Findings:
  • Achieved primary safety endpoint.
  • Demonstrated statistically significant improvements in several secondary efficacy endpoints.
  • Notable improvements in retinal structure and visual function were observed.

Trial Design

  • Study Type: Randomized, double-blind, placebo-controlled, multi-center trial.
  • Population: 36 patients with unilateral acute optic neuritis.
  • Treatment Regimen: OCS-05 (2mg/kg/day or 3mg/kg/day) administered intravenously once daily for five days alongside steroids.

Efficacy Results

  • Primary Endpoint: Safety
  • No significant differences in abnormal ECG parameters between treatment and placebo groups.
  • 12.5% of patients in both treatment arms experienced mild and transient ECG abnormalities, deemed not clinically significant.
  • Secondary Efficacy Endpoints:
  • Retinal Thickness:
    • Ganglion Cell-Inner Plexiform Layer (GCIPL): 43% improvement in thickness at 3 months (p=0.049) and maintained at 6 months (p=0.052).
    • Retinal Nerve Fiber Layer (RNFL): 28% improvement at 3 months (p=0.045) increasing to 30% at 6 months (p=0.033).
  • Visual Function:
    • Improvement in low contrast letter acuity (LCVA) with a mean change of approximately 18 letters at 3 months (p=0.004) and about 15 letters at 6 months (p=0.012).

Adverse Events

  • Safety Profile:
  • No serious adverse events (SAEs) related to the drug.
  • No adverse events leading to drug withdrawal or study discontinuation.
  • Common drug-related adverse events (>10% incidence) included headache and acne (both reported in 10.5% of patients).

Regulatory Status

  • The Investigational New Drug (IND) application for OCS-05 has been cleared by the U.S. FDA, allowing for clinical development in the United States.

Conclusion

The report indicates a promising outlook for Oculis Holding AG, particularly with the positive results from the Phase 2 ACUITY trial for OCS-05 in treating acute optic neuritis. The company's strong cash position suggests it has the resources to support ongoing and future clinical developments. These results may enhance the company's prospects for future investments and market opportunities.