Atticus Medical & Medicines Development for Global Health enrol first patient in Phase 2b study of moxidectin in scabies

Melbourne, Australia, 28 November 2023 – Atticus Medical and Medicines Development for Global Health, today announced that the first participant has been enrolled in a Phase 2b clinical study of moxidectin in patients with scabies.

The multi-national, randomized, double-blind, placebo-controlled study (protocol number MDGH‑MOX‑2002; NCT05875441) is designed to evaluate the efficacy and safety of 8, 16 or 32 mg of moxidectin compared to placebo in adults with scabies. The primary endpoint of the study is the number of participants achieving complete cure 28 days after treatment. Recruitment is on-going, with sites open or soon to open in the United States, the Dominican Republic, El Salvador, Puerto Rico and Honduras.

Curt LaBelle, Director of Atticus Medical, commented: “This is an important milestone towards providing scabies patients with improved treatments options. Annually, scabies impacts more than half a billion people globally, with around ten million of those in high-income countries. Developing moxidectin for scabies is a perfect illustration of how Atticus Medical can make a difference for patients suffering from neglected diseases, whilst also providing return for investors.”

Moxidectin is an investigational medicine that could be a single dose oral treatment for scabies, potentially simplifying the current treatment options. If successful, moxidectin could dramatically improve the scabies treatment paradigm as existing topical treatments are cumbersome whilst oral treatments are not approved in all jurisdictions. All treatment options typically require more than one dose for the best outcomes. Atticus Medical owns the rights to moxidectin in high-income countries and works with Medicines Development for Global Health to deliver the drug in low- and middle-income countries.

Mark Sullivan AO, Managing Director of Medicines Development for Global Health said “We are excited to have begun the dose confirmation study of moxidectin in the treatment of scabies. Moxidectin is approved or under development for the treatment of six parasitic diseases that impact more than a billion people globally, and it has the potential to become one of the most transformational medicines in global health.”

About Atticus Medical Pty Ltd

Atticus Medical is a clinical-stage, Australian biotechnology company developing moxidectin for the potential treatment of scabies and headlice. The company was established in December 2019 by the Global Health Investment Fund 1, LLC (a double bottom-line investment fund) and Medicines Development for Global Health (a not-for-profit biopharmaceutical organisation) using part of their respective entitlements to proceeds of the 2019 sale of a priority review voucher awarded by the United States Food and Drug Administration.

Atticus Medical has a unique for profit, for purpose model, having been established to commercialise new treatments for infectious diseases in high-income countries, while enabling social impact in low- and middle-income countries through its not-for-profit partner, Medicines Development for Global Health.

Further information is available on our About page.

About Medicines Development for Global Health

Medicines Development for Global Health is a not-for-profit, independent biopharmaceutical organisation, dedicated to the development and delivery of new and improved medicines for diseases that disproportionately affect people in low- and middle-income countries.

Medicines Development for Global Health was founded in 2005 by Mark Sullivan AO. Its expertise is in the product development process which is applied to advancing medicines and vaccines that address important unmet needs. In 2018 it achieved United States Food and Drug Administration approval of moxidectin for the treatment of river blindness (onchocerciasis) and is currently developing moxidectin for the treatment of several other neglected tropical diseases. In 2020 Medicines Development for Global Health secured global rights to dovramilast (previously known as CC-11050 or AMG 634), a treatment that holds promise in tackling tuberculosis and leprosy type 2 reaction.

Further information is available at www.medicinesdevelopment.com

About moxidectin

Moxidectin is an oral antiparasitic medicine from the same class as ivermectin, under investigation for several parasitic diseases caused by worms and arthropods.

Moxidectin was approved in 2018 by the United States Food and Drug Administration for the treatment of onchocerciasis in people aged 12 years and older. Medicines Development for Global Health developed moxidectin for onchocerciasis in partnership with the Special Programme for Research and Training in Tropical Diseases (TDR).

Moxidectin has been assessed in a Phase 2a study in patients with scabies, which was completed in March 2022 (EudraCT No. 2019-001775-37, protocol MDGH-MOX-2001, NCT03905265). Moxidectin is not yet approved for use in scabies.

About scabies

Scabies is a common ectoparasitic skin infestation caused by the mite Sarcoptes scabiei variant hominis. Scabies occurs in all countries, affecting people of all ages; in 2017 it was estimated to affect 100 to 200 million people at any time. Populations at greatest risk live in socioeconomically disadvantaged settings where access to healthcare is limited or where overcrowding is common. Reflecting its burden in these settings, scabies was formally adopted as a World Health Organization-recognised neglected tropical disease in 2017. Read more about scabies on our pipeline page.

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