Phase 2 Trial Results for Samumed Genetic Hair Loss Treatment

One of the highlights of the 2016 annual meeting of the American Academy of Dermatology (AAD) came from a company who hoped to treat severe pattern hair loss in men.

Samumed LLC representatives at the 74th meeting of the AAD took the opportunity to relay the initial clinical trial results to their peers, creating a wave of interest in their work. The point of difference with SM04554 - the new type of treatment under review - is, according to its developers, that it is designed to work in cases of baldness.

Point of difference

Currently, MHRA and FDA approved, clinically-proven hair loss treatments can help to stabilise shedding and promote regrowth in many cases of Male Pattern Baldness - from the earliest signs of hair thinning, to advanced hair loss. However, in some instances of hereditary balding, the skin takes on a shiny appearance as a sign that the hair follicles no longer function. This is considered true baldness and once this occurs it is generally viewed as being 'too late' for pharmaceutical treatment to be worthwhile.

Now the 75th AAD Annual Meeting, which took place over the first weekend in March 2017, has seen Samumed release its Phase 2 scalp biopsy safety and efficacy results. Once again the data is hugely engaging even though the trial was small in scale, with only 49 participants being studied, and was carried out by the manufacturers.

A company press release notes: 'The results suggested that Samumed’s investigational drug, a topical solution of the novel small molecule compound SM04554, may be the first treatment causing follicular neogenesis.' This, in essence, means that the drug may be able to prompt damaged hair follicles to reconstitute.

Latest trial results

The company's latest safety, efficacy and tolerability trials took place across a number of locations and were conducted in a randomised, double-blind manner. Men aged between 18 and 65 with a Norwood-Hamilton Classification of 4, 5, 5A, 5V, or 6 participated and were studied over a 135 day period.

Developing story. Please check back for updates.