Akesis Pharmaceuticals

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Akesis Pharmaceuticals is an emerging metabolic disease company with a unique, patent-protected product that utilizes the insulin enhancing activity of vanadium, a naturally occurring micro-nutrient.  In the last two decades clinical studies have shown that vanadium-containing products lower blood glucose levels in type 2 diabetes patients more substantially than many prescription drugs.  Akesis’ management team is highly experienced in drug development and is leading the company in validating these findings, with the goal of offering unique FDA approved products to treat diabetes and other metabolic diseases that significantly impact public health.  Akesis plans to develop AKP-020, its lead product, as a monotherapy within the $6 billion oral diabetes drug market.

 Akesis in-licensed AKP-020 (bis(ethylmaltolato)oxovanadium (IV), or BEOV), a novel vanadium compound that has shown considerable potential as a treatment for patients with type 2 diabetes, from the University of British Columbia in March of 2007. AKP-020 is anticipated to begin Phase 2 clinical trials after IND submission in 2007. BEOV was advanced through Phase 1 clinical trials by vanadium experts Chris Orvig and John McNeil, both members of the Akesis Scientific Advisory Board.

The addition of AKP-020 (BEOV) substantially accelerates the Akesis' clinical programs for the treatment of type 2 diabetes. Phase 1 data for AKP-020 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.

Akesis' initial product focus is shifting away from AKP-111, combination of metformin plus vanadyl sulfate and chromium picolinate, and towards AKP-020, BEOV monotherapy, and AKP-120, BEOV-metformin combination therapy. Given the existing data on AKP-020, Akesis expects the AKP-020 program to enter the clinic before AKP-120. We anticipate AKP-020 will enter Phase 2 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 combines vanadyl sulfate and chromium picolinate with metformin, a leading first-line treatment for diabetes with $1.4 billion in annual sales. 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.

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 chromium and /or vanadium on lowering blood sugar, providing strong validation for Akesis' pipeline.

Akesis' products will be regulated by the FDA, while current minerals are not, and should thus offer the advantages of consistency and purity, as well as the potential for reimbursement and convenience of a single pill. These benefits provide a basis for both new product introductions and brand extensions in the treatment of diabetes, which affects 20 million Americans.

Akesis' management and advisory team is highly experienced in drug development, hailing from Avalon Ventures, Minimed Inc., Pfizer Inc., DupontMerck, Elan, Chiron, Sytera Inc., and others. A virtual business model helps Akesis keep costs low and allows the company to remain entrepreneurial and efficient. The Company raised approximately $4.2 million in 2006 and believes that will be sufficient to complete the AKP-020 Phase 1b or 2a trial and cover operating expenses into the second half of 2008.

Akesis, founded in 1998, is publicly traded on the BB-OTC as AKES.OB.