A presentation to the American Academy of Dermatology in Washington, D.C. has shown that an experimental drug from Samumed, an unknown San-Diego-based biotechnology firm, is efficient in growing hair among bald men.
The preliminary data, delivered by Yusuf Yazici, Samumed Chief Medical Officer, have demonstrated ‘promising’ results. However, there are many concerns whether the drug will hold up in larger studies or not. The company seeks to bring the topical drug, dubbed as SM04554, into larger research efforts to get an approval from the Food and Drug Administration (FDA).
Initial Test Results
300 patients have undergone the study. They were randomly assigned to get a placebo version without any drug, a 0.15% SM04554 solution, or a 0.25% SM04554 solution.
Those who took the drug experienced an increase of hair in their scalp. Meanwhile, those who belong in the control group have reported hair loss. Generally, hair count significantly declined to 111.50 hairs per square centimeters from 114 hairs. Those who took 0.15% of the solution had a hair count increase to 115 from 104.90. Finally, those who took 0.25% of the SM04554 solution had a hair count gain to 118.50 from 110.80 hairs.
Same results were seen in terms of hair density. However, the drug maker has not yet revealed results in terms of hair quality.
How Does It Work?
The drug, when rubbed on the bald surface of the head, affects a significant signalling pathway discovered in fruit flies that plays a vital role in embryo development and cancer growth in all species, known as the Wnt pathway.
Currently, given the preliminary data, concerns include that the solution is more effective at a lower dose. For drug companies to further the development and study of an experimental drug, a drug response is necessary. Drug response means that the higher the dosage given, the more the efficacy and side effects are seen. Usually, lack of or a poor drug response leads to cancellation of the study.
According to Rochelle Torgerson, Mayo Clinic, Rochester, Minnesota assistant dermatology professor, further studies and research development programs are necessary in order to further evaluate the drug’s safety and achieve the proper and most effective dosage level.