Chelsea Therapeutics International Ltd. (CHTP) said it plans to give the Food and Drug Administration more data on its potential rheumatoid arthritis drug CH-4051 late July. The move follows the agency’s request for more information on preclinical studies, notably histological reports from lower dose groups in the completed toxicology studies. Chelsea also initiated a late stage trial to evaluate Northera, its drug candidate to treat neurogenic orthostatic hypotension related to Parkinson’s disease.CH-4051 is the L-isomer of CH-1504 and second drug candidate from the company’s portfolio of orally bioavailable, non-metabolized antifolates. Both are orally available molecules with anti-inflammatory, autoimmune and anti-tumor properties that potently inhibit dihydrofolate reductase, an enzyme required for cell proliferation.
Preclinical and clinical data to date suggests superior safety and tolerability, as well as increased potency versus methotrexate, currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases. Diseases that may potentially be treated with these compounds include rheumatoid arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis, Uveitus, psoriatic arthritis and several different kinds of cancer.
The company said that given the known toxicities and side-effects of methotrexate, the most widely prescribed antifolate, it believes that the FDA is interested in fully characterizing the safety of its proposed Phase II doses of CH-4051. Chelsea said it anticipates completion of the requested histology reports by late July and in the interim, will explore potential strategies to mitigate any FDA concerns regarding dose while allowing for evaluation of the full dose range.
Additionally, the company announced the initiation of Study 306, a Phase III trial evaluating the efficacy of Northera, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension or NOH associated with Parkinson’s disease, the second most common neurodegenerative disorder in America.
As a result of decreased levels of norepinephrine associated with the disorder, approximately 20% of Parkinson’s disease patients may experience symptomatic NOH, which results from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and falls.
Study 306 is a twelve-week randomized, placebo-controlled, induction-design Phase III trial targeting the treatment of 84 patients with symptomatic NOH associated with Parkinson’s disease.CHTP is currently trading at $2.83, down $0.09 or 2.92%, on a volume of 0.11 million shares on the Nasdaq.
No comments:
Post a Comment