Alzheimer’s drug in development shows potential against osteopenia

A phase 2 study shows 24% of patients with at least a 40% reduction in bone turnover markers.

A new drug in early clinical trials for Alzheimer's disease may have potential as a treatment for osteopenia patients.

In a phase 2 pilot trial, post-menopausal women treated with HCT 1026 (NicOx SA) had a significant reduction in bone resorption markers. The trial reached its primary endpoint, with 24% of patients achieving a response (P<.001), according to a company press release.

HCT 1026 is a nitric oxide-donating derivative of the drug flurbiprofen. The results of the study show the potential for nitric oxide-donation as a therapeutic approach to treating bone disorders, company officials said in the release.

Giancarlo Isaia, professor of internal medicine at the University of Turin, and colleagues conducted an open label, non-placebo controlled pilot study evaluating HCT 1026 against bone turnover. The study involved women with high bone turnover who had experienced menopause within the last five years. Researchers identified bone turnover as free urine deoxy pyridinoline/creatinine ratio of at least 8.5 mmol/mol. Participating patients also needed a lumber spine bone mineral density between -1 and -2 standard deviations from normal.

The researchers excluded the following patients:

those who had bone diseases other than osteoporosis;
those who received treatment with corticosteroids;
those who received an existing osteoporosis treatment within the previous six months; and
those who took NSAIDs within the previous 14 days.

In the study, patients received 100 mg doses of the HCT 1026 twice daily for six months. At six month's follow-up, the researchers found that five of 21 evaluable patients (24%) showed at least a 40% decline in the serum bone resorption marker CTX (P<.001). Additionally, six of 24 evaluable patients (25%) showed a significant decrease in the urinary bone resorption marker NTX (P<.001), according to the press release.

Patients also generally tolerated the drug well, company officials noted.

“This trial for HCT 1026 was preliminary in nature and followed a surrogate marker of the disease, but the results are encouraging as they provide the first clinical data showing potential for NicOx's nitric oxide-donating technology,” Isaia, principal investigator for the trial, said in the release.

HCT 1026 is in clinical development for the treatment of Alzheimer’s disease. In the current study, NicOx used HCT 1026 as a test compound to confirm the activity of nitric oxide-donation in osteoporosis. The company does not expect to conduct further clinical trials in this area other than to generate supporting data for the drug’s Alzheimer’s disease indication.

For more information:
NicOx SA; Web site: www.nicox.com.