News

Hypoparathyroidism - Orphan Drug Approval (EMA)

June 29, 2016 - Entera's oral PTH 1-34 drug for the treatment of hypoparathyroidism has been approved as an orphan drug by the European Medicines Agency (EMA).

New Director – Roger L. Garceau

March 28, 2016 – Dr. Roger L. Garceau, the former Executive Vice President and Chief Medical Officer (CMO) of NPS Pharmaceuticals, Inc. was appointed to Entera’s board of directors. Dr. Garceau brings more than 30 years of experience to Entera's board. Dr. Garceau served in a number of senior leadership positions at Sanofi-Aventis as well as in other pharmaceutical companies.

New Director – Luke M. Beshar

December 22, 2015 – Mr. Luke M. Beshar, the former Executive Vice President and Chief Financial Officer (CFO) of NPS Pharmaceuticals, Inc. was appointed to Entera’s board of directors. Mr. Beshar brings more than 35 years of leadership experience to Entera's board. Mr. Beshar helped reposition NPS as a leading global rare disease biopharmaceutical company, and was a key member of the team that led the $5.2 billion sale of NPS to Shire plc in February 2015.

Hypoparathyroidism - Phase II Results

July 22, 2015 - Entera's drug for hypoparathyroidism, completed its first Phase II clinical trial. The trial met its safety and efficacy endpoint. The trial included 17 hypoparathyroidism patients and was carried out at the Lin Medical Center, Haifa as well as at the Hadassah Medical Center, Jerusalem. The study showed a significant reduction in calcium supplementation while maintaining the blood calcium levels. Entera’s oral PTH 1-34 was well tolerated and had a high level of compliance. No related adverse events were recorded in the 17 subjects completing the trial. (2 additional subjects were excluded from the trial following the first treatment day. One of these subjects had hypercalcemia prior to receiving the study drug and the other withdrew consent).

New Director – Gerald M. Lieberman

December 17, 2014 – Mr. Gerald M. Lieberman, a former President and Chief Operating Officer at Alliance Bernstein L.P. (until 2009), was appointed to Entera’s board of directors. Mr. Lieberman brings to Entera many years of experience as an executive in leading financial services companies and provides finance, risk management and operating expertise.

Hypoparathyroidism - Phase II

August 20, 2014 - Entera's drug for hypoparathyroidism, enters Phase II clinical trials. The trials will include at least 15 hypoparathyroidism patients and will be carried out at the Lin Medical Center, Haifa as well as at the Hadassah Medical Center, Jerusalem.

Hypoparathyroidism - Orphan Drug Approval

April 24, 2014 - Entera's  drug for the treatment of hypoparathyroidism has been approved as an orphan drug by the U.S. Food and Drug Administration (FDA).

Hypoparathyroidism - Orphan Drug Application

January 22, 2014 – Entera has submitted to the U.S. Food and Drug Administration (FDA) an application for recognition as an orphan drug for the treatment of hypoparathyroidism with Entera’s oral PTH 1-34.

Osteoporosis – Results Support Hypoparathyroidism Application

October 31, 2013 – Additional analysis of Entera's successfully completed Phase I clinical trial using oral PTH 1-34 show that a significant reduction in blood calcium levels was also attained. This provides additional support to the applicability of Entera’s oral PTH 1-34 in the treatment of hypoparathyroidism.

Osteoporosis – IRB Approval for Scale Up Trial

August 27, 2013 - Entera received Helsinki Committee approval to conduct clinical trials that will take place at the Hadassah Medical Center and include 30 healthy volunteers. The influence of production scale-up and of different diets on drug uptake will be tested.

Osteoporosis - Succesful Completion of Phase I

August 25, 2013 - Phase I clinical trials of Entera's oral drug for osteoporosis have been successfully completed. The desirable Cmax - the maximal concentration of the active compound in blood - has been attained with no side effects.

Hypoparathyroidism - Clinical Trials

August 5, 2013 - Entera's drug candidate for osteoporosis will be tried for treating hypoparathyroidism, a rare condition in which the parathyroid glands fail to produce sufficient amounts of parathyroid hormone or the parathyroid hormone produced lacks biologic activity. Entera has submitted an application to the ethics committee in England for ethical approval to conduct a trial at the Norfolk and Norwich University Hospital. The trial is expected to be 4 months long and will include 10 patients.

Osteoporosis - Scale Up Trial

June 10, 2013 - Entera applies to Helsinki Committee for approval of clinical trials that will take place at the Hadassah Medical Center and include 30 healthy volunteers. The influence of production scale-up and of different diets on drug uptake will be tested.

Osteoporosis - Cmax

September 27, 2012 - Entera attains Cmax - the maximal concentration of the active compound in blood at levels similar to those attained by commercial injection.

Osteoporosis - Bioavalabilty

May 8, 2012 - Good interim results are obtained from the Phase 1 clinical trial with Entera's oral PTH 1-34 drug for osteoporosis. No side effects were observed in the 12 volunteers who orally received the drug. In addition, rapid absorption, short distribution time and rapid elimination of the drug indicate its potential as a drug.

Osteoporosis - Phase 1 Clinical Trials

September 19, 2011 - Entera completes the first stage in Phase 1 clinical trials for its osteoporosis drug. The trials were carried out at the clinical trials unit at the Hadassah Medical Center in Jerusalem and in addition to the main objective of demonstrating safety in humans the Company expects to receive indications of the drug's bioavalability and its penetration to the vascular system. 

Osteoporosis - Animal Trials

March 6, 2011 - Entera has completed animal (pigs) trials of its oral osteoporosis drug. The results demonstrate bioavailability above the Company's expectations paving the way for Phase 1 clinical trials planned to start soon.