Preclinical development

DoNatur isolated a novel API (active pharmaceutical ingredient) of natural origin and completed with them preclinical safety studies (single-dose, 90 day repeated dose, 2 generation-prenatal safety) and tests of genotoxic potential requested for human application. Pharmacology studies have been focused to disclose on pain relief and anti-inflammatory mechanisms of the novel drugs essential for their anti-rheumatic efficacy.

Aim of the pharmacological and clinical investigations is to compare the proprietary novel products with already marketed anti-rheumatic products such as the Non-steroidal Anti-inflammatory Drugs (NSAIDs)   

DON Ointment

A pivotal proof of concept study has confirmed the excellent tolerability of the anti-rheumatic DON-Ointment revealing a significant pain relief (VAS) in osteoarthritis and back-pain patients. The completion of the combined Phase II/III confirmatory trial is projected for the year 2016/17.

DON Injection

DoNatur has already completed a randomized double-blind Phase IIa clinical trial with the novel arthritis pain drug: DON injection with painful shoulder peri-arthritis (PHS) patients. The trial confirmed the significantly higher pain relief score and improvement of the shoulder range of motion (ROM) obtained with the DON-injection treated patients in comparison with those in the placebo group.

A Phase IIb/III clinical trial is projected with roughly 1500 patients as required by the authority for the confirmation of the clinical efficacy of an injection product on a large number of patients.