GlobeStar adds another partner for Project Amethyst clinical trial

Advanced Innovative Partners (AIP) has agreed to assist GlobeStar Therapeutics Corporation and SMI Healthcare in designing and running clinical trials to evaluate Project Amethyst, a patented triple combination of U.S.-approved medications aiming to prevent neurodegeneration due to multiple sclerosis (MS).

This definitive agreement follows a memorandum of understanding between GlobeStar and AIP signed earlier this year, which indicated that the companies would collaborate on aspects of Project Amethyst‘s development.

AIP initially will help in the design and launching of a clinical trial in India, as well as in securing regulatory approvals for GlobeStar’s MS products in North America and Europe. AIP will be paid a monthly consulting fee and bonuses, a portion of which will be dependent on the therapy being approved in the U.S.

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GlobeStar, which retains the worldwide license for Project Amethyst, also recently entered into a partnership with SMI, where it was agreed that SMI would help manage an initial clinical trial and regulatory filings, as well as manufacturing, sales, and distribution in India, and parts of Southeast Asia, Africa, and the Middle East.

“I am pleased that GlobeStar and SMI Healthcare will receive advice and assistance from the superb team at AIP to further the growth of Project Amethyst,” James C. Katzaroff, president and CEO of GlobeStar, said in a company press release. “I … have strong confidence in AIP’s capabilities, relationships and wisdom.”

Inflammatory attacks on healthy nervous system tissue damage and kill nerve cells to cause MS. This neurodegeneration contributes to progressively worsening disability, mobility problems, fatigue, pain, and other disease symptoms.

Project Amethyst is a patented (U.S. patent No. 10610592) oral formulation of three medications — minocycline, fluconazole, and atorvastatin — approved in the U.S. for indications other than MS.

Minocycline, an antibiotic used to treat bacterial infections, is believed to have immunomodulatory and neuroprotective properties. It has been evaluated in MS clinical trials. Fluconazole is an antifungal medication, and atorvastatin is a cholesterol-lowering treatment and potential immunomodulatory agent.

The oral combination of these three medications initially was developed by researchers in Italy. Global rights to the therapy were acquired in 2020 by a subsidiary of Angiosoma, which was renamed as GlobeStar in 2021.

Initial study in MS patients in Italy reported to show promise

Its potential to prevent neurodegeneration in MS was demonstrated in a preliminary study in Italy that enrolled 90 MS patients, ages 25 to 65, and 60 healthy adults as a control group. Eligible patients were required to have been living with MS for between five and 20 years, GlobeStar reported on its homepage.

Participants were given two oral doses of the therapy daily for 45 days, along with a controlled diet.

Study results indicated significant reductions in disability, reflected by lower Expanded Disability Status Scale (EDSS) scores. Specifically, patients’ average EDSS score dropped by at least 1.3 points during a pretreatment period, and by an average of 4.02 points after 45 days of treatment, GlobeStar reported.

Improvements in motor control and balance, better bladder control, as well as reductions in fatigue, also were reported. MRI scans indicated that the therapy led to reductions in brain lesions.

“Through our agreement with GlobeStar Therapeutics Corporation, we will have the opportunity to contribute to the refinement, approval and launch of Project Amethyst therapeutics that we believe will be important tools in the fight against MS,” said Stanley Satz, PhD, chairman and chief science officer at AIP.