Home/Blog/60 Patients Begin Phase IIa Trial of FOL-005

60 Patients Begin Phase IIa Trial of FOL-005

Researchers at two clinics in Germany have begun the Phase IIa trial of Sweden-based Follicum’s promising drug candidate, FOL-005. The trial includes 60 men who are experiencing male pattern baldness. 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.

FOL-005 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.

The drug was first developed over six years ago, and ever since it has been winding its way through the exhaustive scientific process that designed to ensure patient safety. Here’s the path they’ve completed so far:

  • 2012: Trials on mice
  • 2013: Trials on human tissue in-vitro
  • 2015: Trials on human tissue transplanted on mice
  • 2016: Toxicity trials, three months
  • 2016/17: Clinical phase I/IIa trials on humans

To date, the research has confirmed that FOL-005 can promote hair growth – but it can also inhibit hair growth. It all depends on the dose. If the dosage is too low, it isn’t as effective. If the dosage is to 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 pretty good.

In the first clinical study involving humans completed last year, 76 percent of patients experienced increased hair growth. The highest hair density increase achieved was eight percent. Researchers also have determined that patients have experienced no adverse effects from FOL-005.

In June, Follicum announced they are ahead of schedule as they completed recruiting male patients for their Phase II study. For the first time, this study includes injections into the scalps of the patients. It is designed to confirm the effectiveness and safety of FOL-005, and examine the positive and negative effects of different dosages. Researchers will administer FOL-005 or placebo in two separate areas of the scalp. Each patient will be treated three times a week for a total of three months.

“In our forthcoming clinical study the objectives is to reproduce our results from earlier trials concerning efficacy, safety and response on human scalps through injections of FOL-005,” reads a statement on the Follicum website.

In an interview posted on Youtube, Follicum’s CEO, Jan Alenfall, said that beyond studying the drug’s effectiveness and safety, researchers also aim to develop a suitable topical formulation that they believe would be easy for patients to use.

“We have three parallel tracks for a nice, cosmetically attractive formulation,” said Alenfall. “We have succeeded in all three formulations we have in development to have a stable product with good performance.”

The study is expected to be completed and reported by the end of 2018.

While these developments are of course interesting, encouraging and even exciting, one of the big takeaways of this story is just how long the drug development process takes. When they conducted their first trials on mice subjects, President Obama was still in his first term!

Keep this in mind as new discoveries are announced, which seems to be happening every few weeks lately. When new research is revealed and then breathlessly reported in the media as a ‘cure for baldness,’ remember the timeline described in this story. A discovery is just the beginning of a long road that is sure to take a decade and potentially longer to complete.

We will keep an eye on FOL-005 and post updates as they become available. 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 Platelet-Rich Plasma (PRP) Therapy, LaserCap® LCPRO therapy and tricopegmentation, which is a type of scalp micropigmentation specifically to enhance hair restoration results.

Call us today at 713-526-HAIR or 713-526-4247 to learn more and book a free consultation with Dr. Arocha.