Over the past 20 years, hair loss treatments have not made much progress. But several biotech companies are hard at work on the case, tantalizingly close to the breakthrough many patients are hoping for. As body dysmorphia is amplified by our ubiquitous digital world, psychiatrists are increasingly linking the onset of male- and female-pattern baldness to mental health conditions ranging from anxiety to depression.
Closing the gap in preventive care
Preventive treatments are lacking. Until recently, the only drugs approved by regulators were minoxidil and Propecia, both of which were only marginally effective at stopping hair loss, and the former being the only treatment available to women.
Over the past decade, cosmetic surgery has sought to ease that burden. Therefore, the market value of the global hair transplant industry is predicted to exceed 24 billion euros ($28 billion) by 2027. However, hair transplants are expensive and sometimes painful, so they are not a panacea. As a result, there is a huge market for new products that can effectively prevent alopecia, and a range of biotech companies see this as an opportunity.
“The number of patients waiting for new treatments is huge,” said Jan Alenfall, chief scientific officer at Follicum, a Swedish biotechnology company that treats hair loss and diabetes.
“Because transplantation is an invasive method, it also involves infection. Additionally, the hair loss process is generally continuous, so many patients tend to require multiple transplants.”
Jan Alenfall, Follicium CSO
Reconsider topical therapy
This was a research breakthrough that inspired the development of Folicum’s hair loss treatment. Scientists at Sweden’s Lund University, while researching treatments for arteriosclerosis (the thickening and hardening of artery walls that often occurs in older people), discovered that the protein osteopontin, a molecule naturally present in our bodies, discovered that a mutant of the gene could increase hair growth. Mouse growth.
Subsequent research revealed that this protein variant has a highly specific target for hair follicle cells and can accelerate the hair cycle from telogen to anagen. This stimulates the dormant hair follicles and encourages them to start producing visible hair again.
But Follicum’s story reflects the challenges faced by researchers developing hair loss treatments. In June 2021, the company was forced to discontinue development of its lead drug candidate for alopecia after phase 2a trial results showed no significant difference from the placebo group. Folicum is now exploring other avenues for its drug candidates, but this is another blow to a disease that requires more attention from drug developers.
Pattern hair loss occurs because the hair follicles become more sensitive to scalp hormones, especially dihydrotestosterone (DHT). Dihydrotestosterone (DHT) binds to the hair follicle and causes it to shrink until it no longer produces visible hair.
As a result, Italian biotech company Cassiopea is developing its own buzzy product, Breezula. This treatment directly blocks the negative effects of DHT on the scalp, based on a mechanism of action discovered through research into the role of hormones in acne development.
“Our drug actually counteracts the negative effects of DHT around the hair follicle, slowing or stopping hair loss,” explained Cassiopeia CEO Diana Herbert. “And those hair follicles that aren’t completely shut down because of DHT will start producing hair again.”
Helps women with hair loss
The main reason biotech companies are working so hard to develop topical treatments for hair loss is because they have fewer side effects. One of the main limitations of Propecia, an oral drug, is that it is associated with erectile dysfunction due to its effects on hormone levels. Additionally, because it acts systemically, it is unsafe for use in female hair loss patients, a patient group that has traditionally been neglected in this field. Therefore, completely bypassing the hormonal pathway is considered a promising approach.
Cassiopea’s products work on DHT, but due to the topical nature of the treatment, there are no safety warnings like oral medications, and previous research suggests side effects are minimal. As a result, the company initiated a Phase 2 trial of its flagship product in female patients and announced the first positive results in September 2021. However, to date, there is still too little data available on Breezula’s efficacy and safety.
“The treatment options that actually work for hair loss are very limited, and the cycle of social complications is very problematic because it has a huge impact on patients’ self-esteem,” says Herbert. . “This is very embarrassing for them, and research shows that women are even more likely to suffer from these psychological complications than men, so there is a huge unmet need.”
While some solutions offer hope, patients suffering from hair loss must continue to wait to receive the treatment they desire.
Promotion of hair growth and treatment of alopecia areata with JAK inhibitors
Alopecia areata is an autoimmune disease characterized by the sudden, often unpredictable loss of hair on the scalp and sometimes other parts of the body. This condition occurs when the immune system mistakenly attacks the hair follicle, usually causing hair loss in small round patches, but in some cases it can be more widespread.
The exact cause of alopecia areata is not completely understood, but a combination of genetic and environmental factors are thought to be involved. The condition can affect individuals of any age, gender, or ethnic background, but often first appears in childhood or early adulthood. Although the hair loss associated with alopecia areata can be painful, it is important to note that this condition does not cause any physical illness.
Illy Lilly and Pfizer have been in a tight race to win approval for two drugs that showed promise in Phase 3 trials for hair loss.
Developed and marketed by Eli Lilly, Olumiant acts as a Janus kinase (JAK) inhibitor, targeting pathways involved in the immune attack on hair follicles. By inhibiting these pathways, Olumiant reduces inflammation and promotes hair growth.
Approved by the U.S. Food and Drug Administration (FDA) in June 2022 for adults with severe alopecia areata, Olumiant is the first systemic drug approved for this condition. Clinical trials have proven its effectiveness, showing that a significant proportion of participants achieved significant scalp hair regrowth after 36 weeks of treatment.
While Olumiento offers hope for people suffering from severe alopecia areata, it also comes with a number of risks, including serious infections, increased risk of death in older adults with risk factors for heart disease, and the possibility of serious cardiovascular events. Comes with potential side effects and risks.
In June 2023, one year after Ormuniant’s approval, the FDA approved a second JAK inhibitor treatment for alopecia areata, Litoflo. This Pfizer-developed solution is the first treatment approved for adolescents alongside adults with alopecia areata, addressing the needs of a younger population often deeply affected by the psychological and social aspects of hair loss. It emphasizes its importance in coping.
In clinical trials, specifically ALLEGRO’s Phase 2b/3 trial, Litfulo showed significant efficacy in promoting hair regrowth, with 23% of participants achieving significant scalp hair coverage after 6 months of treatment I did. However, like Olumniant, Litfulo comes with potential side effects and risks. These include serious infections, increased incidence of malignancies such as non-melanoma skin cancer and lymphoma, cardiovascular events, and blood clots.
These drugs are known to reduce the immune response because they block the activity of cytokines (small inflammatory proteins). JAK inhibitors can be used to treat cancer and autoimmune diseases such as rheumatoid arthritis. Although these JAK inhibitors have real potential in the treatment of alopecia areata, they remain an important risk factor for patients. Research and development still has a long way to go to solve this condition in a safer way.
Research in hair loss treatment still needs to mature
These companies are investigating a variety of existing and new compounds, while others are seeking to understand more about the molecular mechanisms that underpin human hair growth and loss. The goal is to find an entirely new class of hair treatments, and many companies are investing in early-stage research.
For example, Italian biotech company Giuliani is researching a particularly innovative way to revive dormant hair follicles in hair loss patients. Over the past four years, by studying existing medications for other conditions that cause unwanted body hair growth as a side effect, we have identified an entirely new pathway to stimulate hair follicles.
Although the current picture regarding the future of hair loss treatments is perhaps brighter than ever, Giuliani consultant scientist Ralph Paus says there are still a number of fundamental questions that need to be understood about the science of hair growth. I think there is. If solved in the next few years, it could go a long way toward eliminating baldness for good.
“One of the biggest mysteries about hair follicles is that these tiny little organs follow an autonomous internal clock that drives cycles of growth, regression, and rest,” he says.
“This clock is located within the follicle itself, but the mechanisms that regulate it are unknown. If we can understand how this organ actually works, we can target it pharmacologically. A drug that can interfere with the clock mechanism built into human hair follicles would be a very powerful hair treatment.”
Ralph Paus Consultant Scientist at Giuliani & Co.
In other words, a deeper understanding of the mechanisms behind hair loss is essential for the hair loss industry to advance faster in this field and develop more effective treatments.
New technologies related to hair loss treatment:
This article was originally published by David Cox in February 2021 and updated by Jules Adam in February 2024.
