In The Spotlight: Zafgen

(RTTNews) - Shares of Zafgen Inc. (ZFGN) are up an impressive 129% year-to-date compared to the 4% gain of the iShares Nasdaq Biotechnology ETF (IBB) index during the same period.

Zafgen is a clinical-stage biopharmaceutical company developing potentially transformative therapies for patients affected by a range of metabolic diseases like difficult-to-control type 2 diabetes and Prader-Willi syndrome.

The Company's lead drug candidate is ZGN-1061 for difficult-to-control type 2 diabetes.

ZGN 1061, a twice-weekly injectable, is a second generation methionine aminopeptidase 2 (MetAP2) inhibitor, which successfully completed a phase II clinical trial as recently as last month.

The trial, whose results were reported on June 23, 2018, met all of its primary endpoints, with ZGN-1061 demonstrating a statistically significant reduction in *A1C at 0.9 mg versus placebo at Week 8 and Week 12. The 12-week data also demonstrated a favorable safety and tolerability profile, with no treatment-related serious adverse events and no CV safety signals observed. (*A1C is a biomarker for the diagnosis and prognosis of diabetes).

The Company is also exploring a 1.8 mg dose of ZGN-1061, and results from this additional cohort are expected to be announced in early 2019.

In a mouse model of NASH, ZGN-1061 markedly reduced liver weight, NAS score and markers of liver damage (ALT and AST).

NASH, or non-alcoholic steatohepatitis, refers to liver inflammation due to fat buildup in the liver. An estimated 16 million Americans have NASH, according to reports.

Next in the pipeline is ZGN-1258, and the Company will be exploring its potential initially in the treatment of Prader-Willi Syndrome.

It is estimated that about 200,000 patients worldwide are affected by Prader-Willi Syndrome, which is the most common genetic cause of life-threatening obesity. This syndrome is characterized by unrelenting pathologic hunger (hyperphagia), and the average life expectancy of persons with this condition is roughly 32 years.

Zafgen expects to initiate a phase I study of ZGN-1258 in Prader-Willi Syndrome in the fourth quarter of 2018.

By year end 2018, the Company intends to identify an orally dosed development candidate for liver specific metabolic conditions such as NASH.

Recent events:

-- On July 2, 2018, the Company closed its offering of common stock and exercise in full of the underwriters' option to purchase additional common shares. The offering resulted in total gross proceeds of $69.0 million. -- On June 25, 2018, Zafgen joined the Russell 3000 Index. The shares have gained 44% since the addition to the index.

Key Numbers...

Accumulated deficit: $305.5 million (as of March 31, 2018) Shares Outstanding: 35.56 million

The Company had cash of $89 million at March 31, 2018, and raised total gross proceeds of $69.0 million from a public offering, which closed on July 2, 2018.

ZFGN has traded in a range of $3.21 to $10.75 in the last 1 year. The stock closed Thursday's trading at $10.69, up 2.49%.