OliX Pharmaceuticals, Inc. (KOSDAQ: 226950) made a major breakthrough in the treatment of hypertrophic scars, as the company announced positive headline results of its phase 2a trial. The trial, which was conducted over a 24 week period, randomized adult patients with hypertrophic scars to receive biweekly intradermal OLX10010 or placebo for 12 weeks, starting 2 weeks after surgery.
The primary observer-based endpoint as evaluated by the Patient and Observer Scar Assessment Scale (POSAS) was met at week 24, demonstrating the efficacy of OliX’s innovative therapeutic solution. This double-blind, placebo-controlled, multi-center trial will continue until week 48 after surgery, offering potential long-term relief from hypertrophic scarring.
The biweekly administration of OLX10010 demonstrated a significant improvement in hypertrophic scar appearance compared to baseline after 24 weeks of scar excision surgery. This was evidenced by both the POSAS observer global score (p=.0017, 2-sided) and the POSAS observer total score (p=.029, 2-sided).
Surprisingly, no clear evidence of dose-dependent effects between the 2mg and 5mg doses was observed. Further follow-up of the participating patients up to 48 weeks post-surgery is currently underway.
The trial of OLX10010 has demonstrated its safety and tolerability at both dose levels, with no adverse effects on wound-healing noted. These promising results pave the way for further development of OLX10010 as a potential monotherapy or as part of a combination therapy for hypertrophic scars, which currently lack satisfactory treatment options.
Dr Waibel of the University of Miami Miller School of Medicine, the Subsection Chief of Dermatology at the Baptist Hospital of Miami and Miami Dermatology & Laser Institute, expressed excitement at the potential of OLX10010 to effectively treat hypertrophic scars, a condition that has been notoriously difficult to treat.
CTGF inhibitors such as OLX10010 offer an evidence-based approach to treatment, allowing for less frequent administration, as well as new mechanisms of action. The safety data observed in this trial are particularly encouraging, leading to the possibility of OLX10010 becoming the primary treatment for this indication.
Dr. Dong Ki Lee, Founder and CEO of OliX Pharmaceuticals, is thrilled to share the initial results from the trial of OLX10010, a potential treatment for hypertrophic scarring. This condition presents a major unmet medical need with a significant compound annual growth rate, and with no existing treatment modalities available to effectively address it, the results from this trial come as a major breakthrough. OLX10010 could be used on its own or combined with standard of care and novel treatments, making it a much-needed backbone treatment for patients with hypertrophic scars.
About OLX10010
OLX10010 is an innovative cell-penetrating asymmetric siRNA duplex designed to target human connective tissue growth factor (CTGF). This promising drug candidate has the potential to treat fibrotic diseases such as hypertrophic scars, by interfering with the expression of CTGF and degrading mRNA after transcription.
Currently, the safety and efficacy of OLX10010 is being investigated in clinical trials, and its potential to treat fibrotic diseases is being explored. With further research, OLX10010 could become a powerful tool in the treatment of these conditions.
About OliX Pharmaceuticals
OliX Pharmaceuticals is a pioneering clinical-stage pharmaceutical company utilizing its own exclusive RNAi technology to develop therapeutics for a multitude of disorders. This groundbreaking gene silencing technology, known as asymmetric siRNA (asiRNA), is the most effective gene silencing technology available.
OliX has developed two therapeutic RNAi platforms that have the potential to treat a variety of conditions, including hypertrophic scarring, wet and dry age-related macular degeneration (AMD), subretinal fibrosis, and liver diseases. Cell penetrating asiRNA (cp-asiRNA) and GalNAc-asiRNA are two revolutionary platforms with immense potential to revolutionize the way we treat a variety of diseases.