Specialty pharmaceutical company Hatchtech Pty Ltd today announced positive results for its Phase 2b clinical trial in subjects with head lice infestation. The results confirmed that DeOvo™, a topical head lice treatment, is both safe and highly effective following a single application. The Phase 2b trial evaluated efficacy, safety and tolerability at two dose levels of a single application of DeOvo™ compared to vehicle. The study was conducted in 140 healthy subjects with head lice infestation, 2 years of age and older, at two study centers in the United States.
The primary efficacy results demonstrated a statistically significant (p<0.001) and clinically relevant outcome in both the 0.74% w/v (85.7% treatment success) and 0.37% w/v (67.4% treatment success) treatment groups compared to the vehicle control group (23.4% clearance). Treatment success was defined as subjects who were lice-free 14 days post a single 10-minute treatment with DeOvo.
No serious adverse events were reported in any of the three groups. The majority of adverse events were classified as mild and occurred within the control group; the most common being scalp pruritus (itchiness) which was associated with the continued presence of lice.
Hatchtech's CSO and Founder, Associate Professor Vern Bowles from The University of Melbourne said:
"These exciting clinical results further build on an extensive body of preclinical and clinical data that have confirmed the effectiveness of a single ten minute treatment of DeOvo™ against both lice (lousicidal activity) and more importantly their eggs or nits (ovicidal activity). DeOvo™ is the only known lousicidal and ovicidal agent requiring a single application for effective treatment. An outcome of essentially 9 of 10 patients being cleared of their lice infestation is an outstanding result."
Hatchtech's proprietary DeOvo™ is a topical formulation of an inhibitor of metalloproteinases that are key to biological processes involved in egg development and in survival of the crawling lice.
Recently appointed Hatchtech CEO, Mr Tim Waugh, commented:
"This is very promising news for the many parents and children who constantly face the challenge of head lice outbreaks. There is currently no effective product available offering the ease and convenience of a single application regimen. We now look forward to progressing DeOvo™ through Phase 3 clinical development and bringing this next generation product to the marketplace."