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Xeglyze™ has been approved by the US FDA for the treatment of head lice. The topical lotion was developed by Hatchtech based on University of Melbourne research.
Key points
- Xeglyze™ is a single-application topical lotion that kills adult lice and their unhatched eggs.
- Hatchtech developed the treatment based on University of Melbourne research.
- Hatchtech entered a commercialisation deal with Dr Reddy's Laboratories worth up to $A279 million.
The outcome
Head lice treatment Xeglyze™ has been approved by the US Food and Drug Administration (FDA) for sale as a prescription medicine in the USA. Total sales of head lice treatments in the USA are approximately $US350 million each year.
The treatment was developed by Melbourne-based pharmaceutical company Hatchtech. Unlike most current over-the-counter and prescription treatments, Xeglyze kills both adult lice and their unhatched eggs. The next-generation treatment, which is based on University of Melbourne research, is a topical lotion that requires only one application.
After Phase III clinical studies demonstrated Xeglyze’s safety and efficacy, multinational pharmaceutical company Dr Reddy’s Laboratories agreed to pay Hatchtech up to $A279 million for the rights to commercialise the product in multiple territories.
The need
Apart from causing irritation and embarrassment, head lice can lead to children missing school and their parents missing work. In the USA alone, the economic toll has been estimated at around $US1 billion.
Although infestations are common – with an estimated 6–12 million cases annually among children aged 3–11 in the USA – there have been few advances in head lice treatment in recent years.
Over-the-counter and prescription products often require multiple applications, several days apart, to ensure that both adult lice and newly hatched eggs are killed. It is also recommended that the remaining lice and egg casings are physically removed by combing – a time-consuming and laborious process. Some treatments are becoming less effective as lice develop resistance to their active ingredients.
The research
Head lice, the parasitic insect Pediculus humanus, live on the scalp and feed on human blood. Female lice lay several eggs per day, which take 6–9 days to hatch.
Associate Professor Vern Bowles, from the Faculty of Veterinary and Agricultural Sciences at the University of Melbourne, examined the shell casings of louse eggs and discovered the presence of metalloprotease enzymes. Using commercially available metalloprotease inhibitors, he found that inhibiting these enzymes could prevent egg hatching and thus disrupt the parasite’s life cycle.
Associate Professor Bowles’ subsequent research identified 5,5'-dimethyl-2,2'-bipyridine (abametapir) as a more suitable metalloprotease inhibitor for safe and effective application. Xeglyze, a single-application topical lotion, is the only head lice treatment containing abametapir.
Technology development history
Associate Professor Bowles launched Hatchtech in 2001 and obtained seed funding of $A488 000 from Uniseed, an Australian venture fund operating at the Universities of Melbourne, New South Wales, Sydney, and Queensland, and CSIRO.
After several years of research, Hatchtech filed the first of its patent applications covering the composition and application of its head lice treatment in 2004. This application was subsequently granted in multiple jurisdictions.
Uniseed continued to invest in the company. From 2005 to 2009, it helped to secure additional funding from multiple investors, including the University of Melbourne (which now has a 14 per cent stake in Hatchtech), GBS Venture Partners, QIC BioVentures and Biocomm Services. Subsequent investors include OneVentures (37 per cent stake), Blue Sky Alternative Investments and Australian Super. Hatchtech has also received funding from the Australian Government’s Innovation Investment Fund and through R&D tax incentives. Total funding has exceeded $A40 million.
These funds supported the development of abametapir into the topical lotion Xeglyze, through 75 non-clinical and 11 clinical studies (including Phase III), and a New Drug Application to the FDA in 2015.
In 2015, Hatchtech reached a commercialisation deal with Dr Reddy’s Laboratories. It includes an upfront payment, and pre-commercialisation and sales-based milestone payments, worth up to $A279 million.
Dr Reddy’s acquired the rights to manufacture and distribute Xeglyze in Australia, New Zealand, the USA, Canada, India, Venezuela, Russia and the Commonwealth of Independent States. Hatchtech retains the right to commercialise Xeglyze outside these territories. Hatchtech also retains global rights for non-human applications of the product.
In July 2020, the US FDA approved Xeglyze as a prescription medicine for the treatment of head lice.
Hatchtech is currently investigating other potential animal health applications for its technology.
Partners
Funding support
Publications
Bowles VM et al (2008) Metalloproteases and egg-hatching in Pediculus humanus, the body (clothes) louse of humans (Phthiraptera: Insecta). Parasitology 135(1): 125–130. doi: 10.1017/S0031182007003587
Bowles VM et al (2017) Ovicidal efficacy of abametapir against eggs of human head and body lice (Anoplura: Pediculidae). Journal of Medical Entomology 54(1): 167–172. doi: 10.1093/jme/tjw132
Bowles VM et al (2019) Effect of a new head lice treatment, abametapir lotion, 0.74%, on louse eggs: a randomized, double-blind study. Global Pediatric Health 6. doi: 10.1177/2333794X19831295
Patents
AU2004257351, filed 16 July 2004
AU2014377875, filed 17 December 2014
People
Banner image: Close up of a male louse on strands of hair by GillesSM/Flickr under CC 2.0.