Essential Science
Essential Science:
AKP-020: (bis(ethylmaltolato)oxovanadium (IV), or BEOV): AKP-020 is a novel vanadium compound that has shown considerable potential as a treatment for patients with type 2 diabetes. AKP-020 is anticipated to begin Phase 1b or 2a clinical trials after IND submission in 2007. Akesis' scientific advisory board members, Chris Orvig and John McNeil, helped advance BEOV (AKP-020) through Phase 1 clinical trials. Phase I data showed that AKP-020 has advantages over unpatented vanadyl sulfate with respect to dosing, pharmacokinetics and bioavailability, without any signs of toxicity. The data set includes extensive positive safety and efficacy studies of AKP-020 in rodents and dogs.
AKP-120: (metformin plus bis(ethylmaltolato)oxovanadium (IV), or BEOV) Given the existing data on AKP-020, Akesis expects the program to enter the clinic before AKP-120 (BEOV plus metformin). We anticipate AKP-020 will enter Phase 1b or 2a trials in the second half of 2007, once the appropriate FDA filings are completed and approved. Akesis may elect to perform additional Phase 1 studies for AKP-020 in healthy and /or diabetic patients.
AKP-111 (metformin plus vanadyl sulfate and chromium picolinate): A Phase 2, open-label trial in 81 patients demonstrated that AKP-111 was well-tolerated and lowered HbA1c levels 1.7% more than metformin alone. AKP-111 is a phase 2 ready product candidate.
AKP-201 (glipizide plus chromium): In a study conducted by Pennington Biomedical Research Center, the addition of chromium to glipizide increased insulin sensitivity in patients and attenuated the weight gain typically associated with glipizides.
In addition to AKP-020, AKP-120, AKP-111 and AKP-201, Akesis' pipeline includes AKP-320 (Rosiglitazone plus BEOV) and several other combination products. Hundreds of published clinical and preclinical studies have shown the beneficial effects of vanadium and / or chromium on lowering blood sugar, providing strong validation for Akesis' pipeline.