Mode of action
Hatchtech research has identified that a specific group of enzymes known as metalloproteases are involved in insect egg hatch and survival and subsequently discovered specific compounds that are able to disrupt these processes through their ability to inhibit these enzymes. It is one of these metalloprotease inhibiting compounds that is the active ingredients in DeOvo™. As this is a novel mode of action in the control of lice, it is predicted that DeOvo™ would not be expected to be affected by the development of resistance to existing antilice treatments.
A substantial body of scientific data has established the mode of action and preclinical and clinical studies have shown DeOvo™ to be highly effective. Preclinical and Phase I studies have further shown DeOvo™ to be safe.
DeOvo™ has demonstrated safety and tolerability in a human Phase IIa clinical study, completed in late 2009. This clinical study also demonstrated excellent lousicidal and ovicidal activity following a single application with short (10-20 minutes) treatment time.
This trial, which completed at the end of 2011 evaluated efficacy, safety and tolerability at two dose levels of a single application of DeOvo™ compared to vehicle in a randomised controlled, double blinded study. 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 intends to seek approval for a Phase III trial to start in 2013.
Expressions of interest of a Business Development nature should be directed to the Chairman
Mar 12, 2013 Hatchtech appoints Hugh Alsop as CEO