Follicum Reports Positive Findings in Latest Human Trial of FOL-005 By Bernard Arocha, MD on November 27, 2018

Follicum AB has released initial data from the first phase IIa trial of its promising drug candidate, FOL-005, which it believes can stimulate hair growth. The phase IIa study examined the safety and therapeutic effect of different doses of FOL-005, administered as injections into the scalp. At the highest dose, researchers observed a measurable increase in hair growth. Moreover, they reported minimal side effects, which researchers celebrated as confirmation that the treatment was safe, which is always the first hurdle for any new drug.

We’ve been keeping an eye on the Sweden-based Follicum since they first popped onto our radar back in February 2018, in our story, “Hair Restoration Advances at the Cellular Level.” In July we reported on the start of this trial in our story, “60 Patients Begin Phase IIa Trial of FOL-005.”

FOL-005 was first developed over six years ago and is a shorter sequence of the human protein ostepontin, which is a peptide that has been suggested to play a role in hair growth. While modified slightly, FOL-005 is still based on natural amino acids.

Prior research has confirmed that depending on the dose FOL-005 can promote hair growth – and it can also inhibit hair growth. If the dosage is too low, it isn’t as effective. 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 latest study, 60 men who are experiencing male pattern baldness received injections of FOL-005. Follicum reports that hair growth increased on average by seven hairs per square centimeter. Additionally, a positive effect was shown in the number of hairs in growth phase. At the highest dose, researchers observed an 11 percent increase in the number of hair follicles in growth phase. Meanwhile, the ratio between the number of hairs in the growth phase to those in the dormant phase increased by 18 percent.

“This difference reinforces the other results, which taken together indicate that FOL-005 is a promising treatment for alopecia (hair loss),” said Follicum in its news release announcing the initial study findings. “The dose and treatment length will probably need to be optimized to obtain maximum effect.”

“The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can “awaken” dormant hair follicles,” said CEO Jan Alenfall. “We are now looking forward to starting a new study on the scalp with a larger number of patients.”

The results from the latest study generally track with the findings from the first clinical study involving humans completed in 2017. In that research, 76 percent of patients experienced increased hair growth. The highest hair density increase achieved was eight percent.

In an interview with BioStock posted on the Follicum website, Alenfall said there was one notable difference in the results of the two human studies. In the latest study, the treatment effect on hair density at the highest dose was slightly weaker than in the previous study. As a result, he indicated that researchers will increase the dose, as well as the dose frequency in upcoming studies.

“Nonetheless, this study clearly stated that we were able to activate the hair follicles, which indicates that hair growth should increase further at a more effective dosage and long-term treatment,” Alenfall told BioStock. “This finding is particularly interesting because a short growth phase is the primary problem of hair follicles in alopecia patients.”

Follicum’s focus in that next study will be to evaluate the effectiveness of FOL-005 as a topical formulation rather than an injection. That is scheduled to start about a year from now in the fall of 2019 at the earliest. That study will examine dose, dosing frequency and treatment duration to arrive at an optimized treatment approach. The work is being conducted at the Clinical Research Center for Hair and Skin Science in Berlin and at Bioskin in Hamburg, Germany. Bioskin is heading up the research.

At the same time, the company will focus on finding a partner as it pushes forward with development of FOL-005.

We at Arocha Hair Restoration will continue tracking the development of FOL-005. In the meantime, men and women experiencing hair loss have options that include topical medications and hair replacement surgery, as well as other treatments such as tricopegmentation, which is a type of scalp micropigmentation specifically to enhance hair restoration results.

Call us today at 713-526-HAIR to learn more and book a free video consultation with Dr. Arocha.

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Arocha Hair Restoration

Since 2002, Bernardino A. Arocha, M.D. has been transforming lives through the power of hair restoration. With an artistic approach and a variety of procedures available, Arocha Hair Restoration has a track record of providing stunning results. Dr. Arocha is affiliated with prominent organizations with memberships that include:

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