REHOVOT, Israel, Aug. 25, 2016 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (NASDAQ:NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced financial results for the second quarter ended June 30, 2016 and provided a corporate update.
“We have been very productive in recent months advancing our clinical programs and moving closer toward our goal of providing a less invasive, continuous levodopa delivery treatment option for patients suffering from Parkinson’s disease,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We announced that Trial 005, evaluating ND0612H to DUODOPA® in a head-to-head pilot pharmacokinetic study, achieved comparable results in patients with severe Parkinson’s disease. In addition, we have commenced enrolling patients in three important clinical trials: our first clinical trial for ND0701 (trial 101), our continuous, subcutaneously delivered liquid apomorphine-base formulation; a Phase II trial of ND0612H (trial 006) for severe Parkinson’s disease; and a Phase III trial of ND0612L (trial 007, named the “iNDiGO” trial) in patients with moderate Parkinson’s disease. We look forward to meeting with the FDA in late October to discuss our clinical development program and plan to hold a similar meeting with the EMA later this year,” concluded Dr. Lieberman.
Initiation of a Phase III efficacy trial for ND0612L (trial 007; “iNDiGO”).
Presentation of the study design of the Phase II clinical trial of ND0612H (trial 006) as well as preclinical data on the Company’s new apomorphine product candidate ND0701 at the 20th International Congress of Parkinson’s Disease and Movement Disorders.
Announced ND0612H achieved comparable pharmacokinetics to DUODOPA® in head-to-head pilot PK comparison trial (trial 005).
Started U.S. patient enrollment in a Phase II trial (trial 006) to investigate the efficacy, safety, tolerability and pharmacokinetics of ND0612H to the baseline oral standard of care.
Announced key management additions: Tami Yardeni as Chief Operating Officer and Eran Shor as Vice President of Devices.
Announced the first clinical study (trial 101) for ND0701, a continuous subcutaneously delivered liquid apomorphine-base product candidate for the treatment of advanced Parkinson’s disease, in a bioequivalence trial in healthy volunteers.
Recent tests have demonstrated that, after thawing, ND0612 is stable for up to thirty-five days at room temperature.
Last updated on: 27/08/2016
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