Zafgen Inc (NASDAQ:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced a clinical update for beloranib, the Company’s lead MetAP2 inhibitor product candidate.
After review of its ongoing clinical trials, the Company has elected to proceed with efficacy and safety data analysis and close the randomized portion of its Phase 3 ZAF-311 clinical trial of beloranib in patients with Prader-Willi syndrome (PWS) and its ZAF-203 Phase 2b clinical trial of beloranib in patients with severe obesity complicated by type 2 diabetes.Zafgen believes that a sufficient number of patients have completed randomized treatment in both clinical trials to assess the efficacy of beloranib and help inform next steps for the beloranib program. Following the partial clinical hold announced last week, the Company believes it can best preserve the integrity of the data in each clinical trial by closing the randomized portion of the clinical trials early. The Company, based on consultation with the U.S. Food and Drug Administration (FDA), expects ZAF-311 to remain a pivotal clinical trial. The Company expects to report top-line results from both the ZAF-311 and ZAF-203 clinical trials in the first quarter of 2016.
Zafgen will continue the six-month open label extension (OLE) of the ZAF-311 clinical trial in PWS to obtain important ongoing efficacy and safety data. As previously planned, the Company is continuing to offer an open-ended, unblinded extension study after patients have completed six months of OLE.
In consultation with the FDA, a full assessment of the safety and efficacy data from ZAF-311 will be performed to inform the design of ZAF-312, the Company’s second PWS Phase 3 clinical trial. The FDA has informed the Company that it will review the ZAF-311 clinical trial results on the basis of an abbreviated data package.
“The strategic decision to analyze results from the ZAF-311 and ZAF-203 clinical trials early allows us to better preserve data integrity by limiting dose interruption in both clinical trials, and inform the future development of this important product candidate,” said Dennis Kim, M.D., Chief Medical Officer of Zafgen. “PWS is a life-threatening and complex rare disorder that severely impacts the quality of life of both patients and their families, and we continue to believe that beloranib may have an important role in addressing hyperphagia and underlying obesity associated with this disorder. We will continue to treat, closely monitor and follow patients in the ZAF-311 extension portion of the clinical trial.”
As previously reported, Zafgen learned of a patient death in the ongoing Phase 3 ZAF-311 clinical trial of beloranib in PWS, and it subsequently received notice from the FDA that beloranib has been placed on a partial clinical hold. Although the autopsy report remains to be received, the cause of death based on the death certificate has been determined to be respiratory failure due to pulmonary emboli. However, it is not known if this event was related to treatment with beloranib.
“Patient safety is paramount and we will continue to work with regulators on current and future clinical trials of beloranib. Beloranib has demonstrated important clinical outcomes in patients with complicated and severe obesity, including patients with PWS,” said Dr. Thomas Hughes, Chief Executive Officer of Zafgen. “We look forward to analyzing results from our ZAF-311 and ZAF-203 clinical trials, and to advancing our programs. We remain committed to the PWS community and to the development of beloranib.” (Original Source)
Shares of Zafgen closed yesterday at $10.72. ZFGN has a 1-year high of $55.36 and a 1-year low of $10.06. The stock’s 50-day moving average is $33.19 and its 200-day moving average is $35.06.
On the ratings front, Zafgen has been the subject of a number of recent research reports. In a report issued on October 19, Suntrust Robinson Humphrey analyst Edward Nash maintained a Buy rating on ZFGN, with a price target of $25, which represents a potential upside of 133.2% from where the stock is currently trading. Separately, on the same day, RBC’s Simos Simeonidis reiterated a Buy rating on the stock and has a price target of $20.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Edward Nash and Simos Simeonidis have a total average return of 35.5% and -19.1% respectively. Nash has a success rate of 55.0% and is ranked #241 out of 3795 analysts, while Simeonidis has a success rate of 26.8% and is ranked #3739.
Overall, one research analyst has assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $36.00 which is 235.8% above where the stock closed yesterday.
Zafgen Inc is a biopharmaceutical company dedicated to improving the health and well-being of patients affected by obesity. Beloranib is the Company’s product candidate.