Samumed Continues Testing New Ointment, Seeking FDA Approval

Questions Persist Despite Phase Two Trial Finding 10 Percent Increase in Hair Follicles The effort to create hair follicles outside of the body continues to generate a lot of excitement and investment. We previously updated you on the work of Columbia University researcher Angela Christiano who is working on lab-grown hair. The latest buzz comes from Samumed, a biotech company that until recently was operating behind closed doors to develop drugs that some believe could reverse certain aspects of aging – including hair loss. That is a pretty outrageous claim, so let’s examine what we actually know about Samumed’s work to date. Samumed most recently presented phase-two trial data at the American Academy of Dermatology conference in Washington, D.C. in March. According to Samumed’s Chief Medical Officer, Dr. Yusuf Yazici, their experimental drug, code named SM04554, is a so-called “Wnt drug” that targets certain proteins that scientists think play a critical role in the development and renewal of stem cells. If you’ve never heard of Wnt, you probably will soon. Figuring out how to disrupt or activate “WNT pathways” has become a major emphasis in cancer research. In August, Science Daily published the story, “Discovery of a novel Wnt inhibitor with potential to eradicate colorectal cancer stem cells, report researchers.” The Samumed study of SM04554 involved 300 male patients. The study subjects were assigned randomly to one of three groups that either:

1. Received a placebo version of the topical solution without any drug;
2. Received a 0.15 percent solution of SM04554; or
3. Received a 0.25 percent solution of SM04554.

The drug was applied to the heads of the individuals in latter two groups. After about four and a half months (135 days), those in the control (placebo) group continued to lose hair, which is to be expected. Hair count dropped from 114 hairs per square centimeter to 111.5. Patients who took the drug experienced hair growth. Researchers examined the number of hairs in a one square centimeter area of their scalp. Among those in the 0.15 percent group, hair count increased 9.6 percent. Those in the 0.25 percent group experienced a lower percent change with hair count increasing 6.9 percent. According to Samumed, side effects were minor or nonexistent: “SM04554 appeared to be safe and well-tolerated. There were no serious adverse events (SAE) observed in the treatment groups, and the incidence of adverse events (AE) was similar between treatment and control groups.” So far, all research has been focused on men. Samumed’s plan is to extend the testing to women and eventually cycle SM04554 into larger studies, which is clearly necessary. As others have observed, it is usually a red flag if the effectiveness of a drug goes down when you increase dosage. Dr. Yazici attempted to shrug it off as a “Goldilocks Zone,” in which the challenge is finding the dosage that is just right. He reported seeing similar results in studies on animals and hypothesized that applying too high a dosage over-stimulates cells, which could diminish hair growth. What are the chances we’ll see Samumed’s topical ointment hit the market before the end of the decade? At Arocha Hair Restoration, we believe in the power of positive thinking, but we also are realistic. Only about 20 percent of drugs that reach this stage of research ever make it to market. The Food and Drug Administration will require that any new drug be superior to the two drugs the FDA has already approved to treat hair loss: Finasteride (Proscar®, Propecia®), which is effective at generating new hair growth, and Minoxidil (Rogaine®), which slows hair loss. Based on what we know, it appears possible that the Samumed drug could have some advantages, especially if women see positive results. Propecia® is considered dangerous for women, so Minoxidil is their only option, and it only slows hair loss. We’ll keep our eye on Samumed and post updates as more information becomes available. Other Reading: Cure Baldness? Heal Arthritis? Erase Wrinkles? An Unknown Billionaire's Quest To Reverse Aging http://www.forbes.com/sites/matthewherper/2016/04/13/the-god-pill/ An experimental treatment wants to harness the power of stem cells to treat baldness http://www.businessinsider.com/whats-the-samumed-baldness-treatment-2016-3 Hair Loss Talk interview with Dr. Yazici https://www.hairlosstalk.com/interact/threads/samumed-interview-w-dr-yusuf-yazici.95424/