Follicum and Follica Hair Treatment Continue Research Studies
We have been seeing quite a bit of activity coming out of Sweden-based Follicum in recent months as it continues to advance what some believe is likely to be the first new medical treatment for hair loss since the 1990s.
The last time we posted an update on Follicum’s progress with its promising drug candidate, FOL-005, was November 2018. They reported positive findings in a Phase IIa study involving 60 patients who had FOL-005 injected into their scalps. One of the intended outcomes of that study was to gather information that would help Follicum develop an effective topical formulation of FOL-005, which is now ready to be tested.
FOL-005 has been in development for the better part of a decade and is a shorter sequence of the human protein ostepontin, a peptide that is believed to play a role in increased hair growth. While modified slightly, FOL-005 is still based on natural amino acids.
In recent weeks, Follicum announced plans to start a Phase IIa clinical study with a topical formulation of FOL-005 after receiving approval from the German Medicines Agency and the German Ethics Committee. This will be a much larger clinical trial than the previous human trial, with approximately 200 patients. They will be divided into a treatment group who will be treated with FOL-005 and a control group who will get a placebo.
The upcoming phase IIa study, which will be conducted in collaboration with the Charité Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin and proDERM, Hamburg, Germany, aims to investigate the safety, efficacy of and response to FOL-005 applied as a topical formulation.
As designed, the patients will apply FOL-005 or placebo to the scalp once daily in the evening. Researchers will test the effectiveness of three different doses to see which has the greatest positive impact on hair growth. The formulation strength has been a focus of great interest as prior research has found that if the dosage is too low, it isn’t as effective, but if the dosage is too high, it appears to slow or stop hair growth altogether. The key to its effectiveness is to find the best dosage. When that happens, the results appear to be good.
In the article, “Could We See a New Dawn for Hair Loss Treatments?” published in Labiotech.eu, Jan Alenfall, CEO of Follicum said the fact that FOL-005 avoids hormonal pathways could make it a particularly suitable for women to stimulate hair regrowth.
“There are several potential advantages with a new, non-hormonal, mechanism of action,” Alenfall told Labiotech.eu. “The side effects of current therapies are not expected, and none have been seen in the clinical program performed so far. Based on this, [Follicum’s drug] might become a safe and efficacious treatment option for women as well.”
The planned Phase IIa study is expected to be completed and the results communicated by the end of 2020.
Study To Evaluate Alternatives to Hair Transplant Surgery
Another interesting announcement recently came from Follica, another company we’ve posted about in the past. Their work is centered around what the company describes as “targeted scalp disruption.” That’s a fancy term to describe microneedling, which is usually done through the use of a skin roller with tiny needles that activates the body’s natural wound response. Also called micro-wounding, this process apparently stimulates stem cells and causes new hair follicles to grow.
Follica has been testing a hair regrowth treatment regimen that uses what they call the Follica Hair Follicle Neogenesis device (sounds like a microneedle roller) in combination with application of topical Minoxidil.
Follica’s study involved patients undergoing a quick microneedling procedure, with Follica evaluating a range of variables to determine the optimal frequency and number of treatments. The selected treatment regimen recorded a 44 percent improvement of visible (non-vellus) hair count after three months of treatment compared to baseline.
“Our data show that clinical results differ significantly based on the approach to disrupting the skin and confirm Follica’s proprietary treatment paradigm is optimized for new hair growth. We look forward to initiating the pivotal trial,” said Jason Bhardwaj, chief executive officer of Follica.
The company announced plans to initiate a Phase 3 registration study in the first half of 2020.
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