Biotechnology firm RXi Pharmaceuticals has initiated the third Phase IIa trial (RXI-109-1402) with RXI-109 for the reduction of recurrence of hypertrophic scars following elective scar revision surgery.
The company is focused on discovering, developing and commercialising new therapies that address major unmet medical needs using RNA-targeted technologies.
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In the Phase IIa trial, patients with either one long hypertrophic scar or two scars comparable in length, anatomical location and characteristics are eligible to receive scar revision surgery.
The company said that for a single scar, a portion of the revised scar segment will be treated with RXI-109 and a comparably sized portion on the opposite end will be left untreated.
For patients with two scars, a portion of one revised scar segment will be treated with RXI-109 and one scar will be left untreated after revision surgery.
RXi Pharmaceuticals president and CEO Dr Geert Cauwenbergh said: "The company continues to deliver against its projected corporate milestones with the initiation of this third study.
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By GlobalData"This study is another step forward to bringing our self-delivering (sd-rxRNA) RNAi technology closer to market.
"We are very excited by everything we have been able to achieve with our compounds, thus far, and we look forward to providing further updates in the near future."
The third Phase IIa trial will follow patients for nine months. Investigative and independent reviewer assessments will be used to evaluate the effectiveness of RXI-109 in preventing scar formation.
Reviewers will compare the appearance of the untreated areas with the appearance of the revised areas after treatment with RXI-109.
The company said that the first clinical trials with RXI-109 (RXI-109-1201 and RXI-109-1202) showed excellent safety and tolerability with ascending single and multiple doses, as well as dose dependent effects on the CTGF protein and on the mRNA that controls production of this protein.
