Samumed, LLC is engaged in small molecule drug development using assays and screens for the treatment of oncology and degenerative diseases. Samumed, LLC was known as Wintherix & Epitherix, LLC. The company was founded in 2007 and is based in San Diego, California.
9381 Judicial Drive
San Diego, CA 92121
Founded in 2007
Samumed Announces Increases in Both Hair Count and Hair Density Observed in its Phase II Study for a Potential Treatment of Androgenetic Alopecia
Dec 4 15
Samumed, LLC announced preliminary analysis of efficacy data from its Phase II AGA trial, in which one of the dosage arms, compared to vehicle, showed statistically significant increases for both objective outcome measures: non-vellus hair count (a primary outcome measures) and hair density (a secondary outcome measures), using the pre-specified statistical model. Samumed’s investigational drug is a topical solution of its novel small molecule compound SM04554. The 300-subject, multi-center, randomized (1:1:1), double-blind, vehicle-controlled trial studied the safety, tolerability and efficacy of two different doses of SM04554 in male subjects with AGA between the ages of 18 and 55 with Norwood-Hamilton hair loss classification scales of 4, 5, 5A, 5V, or 6. The study involved a 90-day once-a-day treatment period and a 45-day post-treatment follow up. The primary endpoints were the objective quantification by macrophotography of non-vellus hair count, and the subjective assessment of hair quality by subject-completed Men’s Hair Growth Questionnaire. The findings are consistent with preclinical in vivo animal models, in which SM04554 has been shown to generate new hair follicles and increase hair count. The safety results from its Phase II study, as well as results from a previously completed Phase I study, were presented at the 9thWorld Congress for Hair Research (WCHR) in Miami, Florida on November 21, 2015. As the company previously announced, in the Phase II study, there were no serious adverse events observed in any treated patient, and the incidence of adverse events was similar between treatment and vehicle groups.
Samumed, LLC to Announce Clinical Data on Potential Treatment of Androgenetic Alopecia at the World Congress for Hair Research
Nov 18 15
Samumed, LLC announced that it will present clinical data on a small molecule (SM04554, an investigational new drug) for potential treatment of androgenetic alopecia (AGA), commonly known as male pattern baldness, at the 9thWorld Congress for Hair Research (WCHR) in Miami, Florida. The company is a Silver Sponsor of the meeting. In preclinical in vivo studies, SM04554 has been shown to regenerate new hair follicles and increase hair count in multiple animal models. The company has finished a Phase I trial and is about to complete its Phase II trial with the same potential AGA treatment. At the WCHR, Samumed will present clinical results detailing safety, pK, and patient and investigator-reported efficacy data from a 28-day (14 day dosing, 14 days of follow-up), placebo-controlled, double-blind, randomized Phase I clinical trial of SM04554 in male AGA patients between the ages of 18 and 60 with Norwood-Hamilton Classification scores of 4, 5, 6, or 7.