Male Hair Loss Treatment Samumed SM04554 Unveils Trial Data
Regenerative bioscience and technology is proving a fruitful area for hair loss researchers at the moment with the likes of Shiseido and RepliCel investigating stem cell applications for addressing male pattern baldness.
As updates from the weekend's 74th Annual Meeting of the American Academy of Dermatology (AAD) announcements leak, could Samumed LLLC have developed a new treatment for advanced male hair loss?
The proposed treatment for androgenic alopecia (AGA) which seems specifically aimed at men given no women were involved in the clinical trial, involves a once-per-day topical application of SM04554 - a drug developed by the Californian pharmaceutical and regenerative medicine company, Samumed LLC.
Known for its innovative work with the Wnt pathway, according to a company press release, Samumed has managed to 'develop small molecule drugs that potentially address numerous degenerative conditions'. SM04554 is described in the same release as a 'novel small molecule compound' but no other information is yet available as to its ingredients or precise makeup.
The drug has been in development for a number of years already, with the safety results from this phase II study and the phase I clinical trial precursor having already been declared in November 2015 at the World Congress for Hair Research.
The phase II multi-centre trial involved 300 male participants aged between 18 and 55, with male pattern baldness classified as stage IV, V, VA, VV or VI on the Norwood Scale. What makes this drug and its trials different to others currently underway is that it is concentrating on treating men with the more advanced stages of hair loss.
These men were treated once a day for 90 days with one of three different products, which were randomly assigned in equal measure to allow for effective comparisons. The three products, distributed on a blind basis so that none of the volunteers knew what they or anyone else was using, were a placebo solution, a 0.15 per cent SM04554 solution and a 0.25 per cent SM04554 solution.
Following the initial daily treatment period, participants were also subject to a follow-up at 45 days after treatment. Using high resolution macrophotography and self-assessment via a survey questionnaire, changes in their non-vellus hair count and hair density were recorded.
Whilst the findings state that men using the placebo solution lost hair during the study dropping from an average 114 hairs/sq cm to 111.5, those using the lower 0.15 per cent dose achieved an average hair count gain (104.9 at start rising to 115 following treatment). Interestingly those applying the higher 0.25 per cent SM04554 solution did not achieve as large an increase, with the average increase being 118.5 from 110.8.
The company's press release states that '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'. However, a report in Forbes suggests that, given only the lower of the two dosages tested during the trial proved significantly effective at regrowing hair, this outcome may have an effect on the drug's future development.
Journalist Matthew Harper states, 'Usually drug makers like to see what’s called a dose response: you give more drug, you get more efficacy and side effects. For some companies, lack of a dose response can be seen as reason to cancel a drug development program.'
“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,” said Chief Medical Officer of Samumed, Yusuf Yazici, M.D. The hope is that the data from the pursuant research will allow the drug to achieve FDA approval in the USA.
No timeline has been mentioned in relation to when Samumed is aiming to have the drug ready to market - assuming it meets the necessary safety, tolerability and efficacy criteria - and hair loss treatments can take years to be made publically available. Luckily for anyone concerned that they are losing their hair now there are already clinically-proven and MHRA and FDA approved treatments for male pattern baldness available.
Further information on the latest SM04554 phase II trial findings are expected to be released shortly, following their presentation at the American Academy of Dermatology in Washington on Saturday 5th March 2016. Once these details are released we will report on these findings here on the Belgravia blog so do check back for the latest updates.
As updates from the weekend's 74th Annual Meeting of the American Academy of Dermatology (AAD) announcements leak, could Samumed LLLC have developed a new treatment for advanced male hair loss?
Topical treatment SM04554
The proposed treatment for androgenic alopecia (AGA) which seems specifically aimed at men given no women were involved in the clinical trial, involves a once-per-day topical application of SM04554 - a drug developed by the Californian pharmaceutical and regenerative medicine company, Samumed LLC.
Known for its innovative work with the Wnt pathway, according to a company press release, Samumed has managed to 'develop small molecule drugs that potentially address numerous degenerative conditions'. SM04554 is described in the same release as a 'novel small molecule compound' but no other information is yet available as to its ingredients or precise makeup.
The drug has been in development for a number of years already, with the safety results from this phase II study and the phase I clinical trial precursor having already been declared in November 2015 at the World Congress for Hair Research.
The phase II multi-centre trial involved 300 male participants aged between 18 and 55, with male pattern baldness classified as stage IV, V, VA, VV or VI on the Norwood Scale. What makes this drug and its trials different to others currently underway is that it is concentrating on treating men with the more advanced stages of hair loss.
These men were treated once a day for 90 days with one of three different products, which were randomly assigned in equal measure to allow for effective comparisons. The three products, distributed on a blind basis so that none of the volunteers knew what they or anyone else was using, were a placebo solution, a 0.15 per cent SM04554 solution and a 0.25 per cent SM04554 solution.
Following the initial daily treatment period, participants were also subject to a follow-up at 45 days after treatment. Using high resolution macrophotography and self-assessment via a survey questionnaire, changes in their non-vellus hair count and hair density were recorded.
Lower dose more effective
Whilst the findings state that men using the placebo solution lost hair during the study dropping from an average 114 hairs/sq cm to 111.5, those using the lower 0.15 per cent dose achieved an average hair count gain (104.9 at start rising to 115 following treatment). Interestingly those applying the higher 0.25 per cent SM04554 solution did not achieve as large an increase, with the average increase being 118.5 from 110.8.
The company's press release states that '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'. However, a report in Forbes suggests that, given only the lower of the two dosages tested during the trial proved significantly effective at regrowing hair, this outcome may have an effect on the drug's future development.
Journalist Matthew Harper states, 'Usually drug makers like to see what’s called a dose response: you give more drug, you get more efficacy and side effects. For some companies, lack of a dose response can be seen as reason to cancel a drug development program.'
More studies needed
“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,” said Chief Medical Officer of Samumed, Yusuf Yazici, M.D. The hope is that the data from the pursuant research will allow the drug to achieve FDA approval in the USA.
No timeline has been mentioned in relation to when Samumed is aiming to have the drug ready to market - assuming it meets the necessary safety, tolerability and efficacy criteria - and hair loss treatments can take years to be made publically available. Luckily for anyone concerned that they are losing their hair now there are already clinically-proven and MHRA and FDA approved treatments for male pattern baldness available.
Further information on the latest SM04554 phase II trial findings are expected to be released shortly, following their presentation at the American Academy of Dermatology in Washington on Saturday 5th March 2016. Once these details are released we will report on these findings here on the Belgravia blog so do check back for the latest updates.
The Belgravia Centre
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