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November 6, 2007

Akesis Pharmaceuticals Files IND for Phase IIa Trial of AKP-020 to Treat Type 2 Diabetes

Akesis Pharmaceuticals, Inc.

SAN DIEGO (October 31, 2007) – Akesis Pharmaceuticals, Inc. (OTC/BB: AKES), an emerging diabetes drug-development company, today announced that it has filed its first Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its lead product candidate AKP-020, a novel vanadium compound that is expected to show considerable potential as a treatment for patients with Type 2 Diabetes.  This IND submission follows the pre-IND filing in early July, from which the Company received constructive feedback from the FDA. 

Upon FDA approval of the IND application and protocol, Akesis intends to initiate a Phase IIa open-label, single arm U.S. clinical trial in diabetic patients for AKP-020.  The trial will be performed by dgd Research, Inc. of San Antonio and will be designed to measure efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping test), pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetics.  Subject to the timing of obtaining the required FDA approval, the Company is currently projecting the trial to begin in the fourth quarter of 2007.

“The IND filing is an important milestone for the Company, and we continue to stay on track with our development timeline,” said Jay Lichter, president and chief executive officer of Akesis. 

Earlier this year, Akesis initiated 28-day renal-focused safety and toxicology studies in rats and dogs for AKP-020.  The Company will report these results as soon as feasible once they become available.

AKP-020 is the product designation for a novel vanadium compound otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV.  The compound was invented and developed by University of British Columbia researchers Chris Orvig, professor of chemistry and pharmaceutical sciences, and John McNeill, Ph.D., professor and dean emeritus, pharmaceutical sciences, and is licensed exclusively to Akesis Pharmaceuticals.  Professors Orvig and McNeill, who are experts in the study of metal chemistry and pharmaceutical sciences, helped to advance the BEOV program through Phase I clinical trials.  They also are members of the Akesis Scientific Advisory Board.


About Akesis Pharmaceuticals
Akesis Pharmaceuticals has a pipeline of innovative oral product candidates for the treatment of diabetes and related metabolic disorders.  These product candidates are supported by issued and filed U.S. patents for both prescription and over-the-counter treatments that combine anti-diabetic trace minerals with certain classes of diabetes oral agents.  Akesis' product candidates have demonstrated preliminary evidence of efficacy in lowering and controlling blood glucose levels in patients with Type 2 diabetes.  Blood sugar control via oral drugs represents a market opportunity in the billions of dollars, as reports indicate that approximately 20 million people suffer from diabetes in the United States alone. More information can be found at www.akesis.com.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These forward-looking statements can generally be identified as such because the context of the statement will include words such as "will", "expects", "should", "believes", "anticipates" or words or phrases of similar meaning. Examples of such statements include statements relating to Akesis’ ability to secure critical FDA approvals of its proposed studies and the initiation of a Phase IIa trial relating to AKP-020. Stockholders, potential investors and other readers are cautioned that these forward-looking statements are predictions based only on current information and expectations that are inherently subject to risks and uncertainties that could cause future events or results to differ materially from those set forth or implied by the forward-looking statements. Certain of those risks and uncertainties are discussed in Akesis’ filings with the Securities and Exchange Commission, including Akesis’ most recent annual report on Form 10-K (as amended by its annual report on Form 10-K/A) and quarterly reports on Form 10-QSB. These forward-looking statements are only made as of the date of this press release, and Akesis does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

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