Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) shares began Tuesday’s session in the red, as the commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an investigational oral melanocortin-4 receptor (MC4R) agonist, in hypothalamic obesity.
“Based on LG Chem’s significant preclinical work and encouraging results from a Phase 1 trial, we believe LB54640 has the potential to be an effective oral therapy for treating MC4R pathway diseases without hyperpigmentation,” said CEO David Meeker. “We look forward to advancing this molecule with the goal of offering a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.”
The Phase 2 trial is a randomized, placebo-controlled, double-blind study to assess the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older (N=28) with hypothalamic obesity. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo for 14 weeks. The primary endpoint of the study is the change from baseline in body mass index after 14 weeks of treatment, and patients may continue on therapy for up to 52 weeks.
RYTM shares let go of 32 cents to $49.46.