HP-101, a novel product candidate with a unique multi-modal mechanism of action, has demonstrated disease-modifying potential in validated preclinical models of multiple sclerosis
SAN DIEGO, CA, March 08, 2021 (GLOBE NEWSWIRE) — Emerald Health Pharmaceuticals Inc. (EHP or the Company), a clinical-stage biotechnology company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases with unmet medical needs, has initiated activities for a Phase 2 international clinical study for the treatment of patients with multiple sclerosis (MS).
“The initiation of this MS Phase 2 study is another important milestone for our lead product candidate, EHP-101,” said Joachim Schupp, M.D., Dr. med., EHP’s Chief Medical Officer. “We have finalized the trial design with our MS Clinical Advisory Board members, who are globally-recognized key clinical opinion leaders in the treatment of MS. We will soon be seeking regulatory approvals to begin the study and look forward to starting clinical site initiations and enrolling multiple sclerosis patients later this year.”
The MS Phase 2 study is an open label study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the company’s lead product candidate, EHP-101, an oral formulation of a patented new synthetic molecule, in patients with relapsing forms of multiple sclerosis (RMS). The study is planned to enroll approximately 50 patients who suffer from RMS (relapsing-remitting and relapsing secondary progressive MS) in approximately 20 study centers in the United States and Australia. Escalating doses administered once or twice daily are planned to be evaluated over a treatment duration of 24 weeks. The dose levels were established based on previous successful 6 and 9-month animal toxicity studies and a Phase 1 human study in 104 healthy subjects, all showing a good safety and tolerability profile.
Along with assessments of safety and tolerability, efficacy endpoints in the Phase 2 MS study will include the changes from baseline in brain lesion activity as measured by MRI; disease progression and disability status, as well as the proportion of relapse-free patients, patient-reported outcomes, and assessments of several biomarkers such as changes in the neurofilament light chain (NfL) levels in the blood, which is a promising diagnostic, prognostic and monitoring biomarker used in assessing neurological diseases.
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