Hyperion Therapeutics closes acquisition of Andromeda Biotech

DiaPep277 is currently being evaluated in a fully enrolled confirmatory Phase 3 clinical study in adult patients, with results anticipated in the first quarter of 2015. DiaPep277 holds Orphan Drug designation in the United States.

"The addition of DiaPep277 to our pipeline is an excellent strategic fit, as it provides us with a late-stage asset that has a potential near-term commercial opportunity in a larger orphan indication," said Donald J. Santel, president and chief executive officer of Hyperion.

"We believe DiaPep277 gives us diversity across our product portfolio, while staying true to our mission to address significant unmet medical needs in orphan indications."

Under the terms of the agreement announced on April 24, 2014 and in conjunction of the closing of the transaction on June 12, 2014, Andromeda became a wholly owned subsidiary of Hyperion Therapeutics in exchange for $12.5 million in cash, less adjustments for expenses incurred in connection with the transaction, and 312,869 shares of Hyperion common stock (valued at approximately $7.85 million based on the average closing price of $25.09 per share for the 15 consecutive trading days ending April 17, 2014).

DiaPep277 is a 24-amino acid peptide derived from human heat shock protein 60 (hsp60) that has demonstrated a specific and beneficial effect on the auto-immune attack of pancreatic beta cells that occurs in patients with Type 1 diabetes. DiaPep277 is designed to preserve endogenous insulin secretion by selectively impeding beta cell destruction without impacting other essential immunological functions or causing systemic immune suppression.

Treatment of new onset Type 1 diabetes patients with DiaPep277 may have several potential benefits, including slowing disease progression, maintaining metabolic control, and reducing risk for diabetic complications. DiaPep277 is administered via subcutaneous injection once every three months and has been studied in over 500 pediatric and adult Type 1 diabetes patients in more than a dozen clinical trials. The compound holds Orphan Drug designation in the United States for treatment of Type 1 diabetes patients with residual beta cell function.

About the DiaPep277 Phase 3 Program

The first Phase 3 trial, DIA-AID 1, was a multinational, randomized, double-blind, placebo-controlled study, which was conducted to evaluate the safety and efficacy of DiaPep277 over a 24-month treatment period in 457 adult new onset Type 1 diabetes patients.

Results in both the modified intent-to-treat and per-protocol populations demonstrated a significant improvement in preservation of glucagon-stimulated C-peptide secretion and a significantly higher proportion of patients who maintained HbA1c target levels in the DiaPep277 treatment arm versus placebo.

DiaPep277 was safe and well tolerated; no significant differences in serious adverse events or adverse events were observed between the treatment and placebo arms. A peer-reviewed manuscript describing the results of the study was published in the May 2014 issue of Diabetes Care.

DiaPep277 is currently being studied in the confirmatory Phase 3 DIA-AID 2 study. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study is investigating the safety, tolerability and efficacy of DiaPep277 over a 24-month treatment period in 474 newly diagnosed Type 1 diabetes patients ages 20-45 years.

The primary endpoint is preservation of glucagon-stimulated C-peptide secretion. Secondary endpoints include percentage of subjects who achieve target HbA1c levels, daily insulin use, and hypoglycemic events. The study, which is being conducted at 100 sites in North America, Europe, Israel and Argentina, is fully enrolled and results are anticipated in the first quarter of 2015.