Samumed SM04554 Named as Potential Cure for Advanced Baldness

added 16th March 2016

A new hair loss treatment, currently in clinical trials, aims to bring hope to men in the latter, more advanced stages of male pattern baldness.


SM04554 is a once-daily topical treatment for genetic hair loss that has been developed by Samumed LLLC, an American pharmaceutical company that specialises in regenerative medicine.


Promising safety data from initial phase I and II studies was announced in November 2015 at the World Congress for Hair Research and generated a lot of interest given the level of baldness the drug is designed to treat. Stages IV, V, VA, VV and VI on the Norwood Hamilton Scale are some of the most advanced cases of male hair loss and far beyond the capabilities of most over-the-counter hair loss products which usually profess to treat ‘moderate’ thinning.


The latest news on this progressive treatment comes from this month’s American Academy of Dermatology annual meeting. Whilst the formulation of SM04554 remains a closely guarded secret, it is believed to involve the Wnt pathway which has recently been found to be key in regulating hair growth and is an area in which the company has made previous advances. So far though all Samumed have confirmed, via a press release, is that they did successfully ‘develop small molecule drugs that potentially address numerous degenerative conditions’.


The blind randomised clinical trial tested two different strengths of SM04554 – 0.15 per cent and 0.25 per cent – and a placebo, which were applied daily over a 90 day period on 300 volunteers who all had the levels of male pattern hair loss outlined above. Forty-five days after this treatment period follow-up assessments were carried out from which the researchers drew their conclusions.


The methods of assessment used included macrophotography to ascertain hair count and density changes, and participant self-assessment with feedback provided via a questionnaire. Findings were as expected in the placebo group, namely hair loss continued so hair count and density decreased from 114 hairs/sq cm to 111.5 on average. A surprising result came with the Samumed formulations, however, in that generally the stronger a medication, the more effective it is – although this can also increase the risk of side effects. Data from this trial indicates that the lower dose of 0.15 per cent was more efficient, with that particular group of test subjects achieving a more significant boost in hair count. Users of the weaker treatment saw a vellus hair count increase from 104.9 to 115, whereas the 0.25 per cent test group registered a gain of 118.5 from 110.8.



Interestingly, given the level of hair loss being studied, the test subjects are fairly young – all between 18 and 55 years of age. A man’s age certainly can play a part in not only how severe his genetic hair loss is but also in how likely treatment is to succeed. Generally these extensive patterns of baldness are more commonly found in older men and male hair loss treatments such as Regaine have a maximum age limit of 65 so it would be good to see this trial extended into upper age ranges where it can be increasingly useful, as it moves forward.
Samumed commented on the research via a press release, stating: ‘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 company’s Chief Medical Officer, Yusuf Yazici, M.D is also quoted, saying: “The Phase II safety and efficacy data so far are very promising and support moving this program into pivotal studies. We are analyzing the efficacy data further.” As such, while research is on-going, there is no information available as to the development timeline or a forthcoming release date for this formula which has the potential to revolutionise male pattern hair loss treatment options for men with severe levels of baldness. For now, finasteride 1mg paired with topical full strength minoxidil formulas are able to treat extensive thinning or a receding hairline in many men unless they are bald and the hair follicles no longer function.

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