News from Follicum I stumbled on. Check below.
As a Investor in this company, what do you guys think?
Follicum successfully completes the Phase I / IIa study and prepares to take FOL-005 into a Phase II clinical trial
Follicum AB ("Follicum") has now obtained the final results from the completed clinical phase I / IIa study. The results after the three-month follow-up period following completion of treatment with FOL-005 show that hair growth has returned to its original levels. The results confirm that Follicum's drug candidate FOL-005 stimulates hair growth during the treatment period.
In January 2016, Follicum initiated a clinical Phase I / IIa study at the Clinical Research Center for Hair and Skin Science ("CRC") at the Charité University Hospital in Berlin, Germany, primarily to evaluate the safety profile of the company's drug candidate FOL-005 and in Second, evaluate power parameters. In February 2017, Follicum announced that FOL-005 was well tolerated and in April 2017, FOL-005 was reported to stimulate hair growth with a statistically assured increase of approximately 8% compared to pre-treatment. The level of hair growth stimulation is similar to that described for preparations on the market.
Three-month follow-up completed
Now three months after the study participants' final treatment with FOL-005, a safety and effect follow-up has been conducted and the study as a whole is thus completed. During this follow-up period, no treatment with FOL-005 has occurred. The results show that the safety profile is very good. Approximately 2% of the growth of hair growth remains after three months without treatment, which should be compared to an increase of approximately 8% immediately after treatment with FOL-005. This confirms that Follicum's drug candidate FOL-005 is well tolerated and has a treatment effect that stimulates hair growth.
In the completed Phase I / IIa study, FOL-005 has been injected on the front of the thighs. Nevertheless, Follicum's substance has shown efficacy results that are in line with what has been published in Phase III studies for existing preparations on the market. The fact that the FOL-005 in the first clinical trial showed statistically-assured effects on hair growth, without the study being primarily designed for this, is very interesting.
Preparations for study on scalp
The next step in the development of the drug candidate FOL-005 is to carry out a study similar to the recent study but on scalp, which is the intended use of FOL-005 where the ambition is to further clarify the effect of FOL-005. In parallel, work on the development of a user-friendly formulation proceeds according to plan. When an optimized formulation has been developed, the company intends to launch a more comprehensive impact study on scalp.
CEO Jan Alenfall comments
- We are excited to report the clinical trials of the clinical phase I / IIa three-month follow-up showing that FOL-005 is well tolerated and had positive effects during the months undergoing treatment. The final results that show that only a portion of the hair-stimulating effect remained when participants did not receive our treatment were expected. The clinical study has shown that treatment with FOL-005 is safe and provides a good effect, despite the fact that we have not developed a final formulation and do not have a complete dose. Overall, these results provide a good reason for the continued development of FOL-005 in the next step of product development.
As a Investor in this company, what do you guys think?
Follicum successfully completes the Phase I / IIa study and prepares to take FOL-005 into a Phase II clinical trial
Follicum AB ("Follicum") has now obtained the final results from the completed clinical phase I / IIa study. The results after the three-month follow-up period following completion of treatment with FOL-005 show that hair growth has returned to its original levels. The results confirm that Follicum's drug candidate FOL-005 stimulates hair growth during the treatment period.
In January 2016, Follicum initiated a clinical Phase I / IIa study at the Clinical Research Center for Hair and Skin Science ("CRC") at the Charité University Hospital in Berlin, Germany, primarily to evaluate the safety profile of the company's drug candidate FOL-005 and in Second, evaluate power parameters. In February 2017, Follicum announced that FOL-005 was well tolerated and in April 2017, FOL-005 was reported to stimulate hair growth with a statistically assured increase of approximately 8% compared to pre-treatment. The level of hair growth stimulation is similar to that described for preparations on the market.
Three-month follow-up completed
Now three months after the study participants' final treatment with FOL-005, a safety and effect follow-up has been conducted and the study as a whole is thus completed. During this follow-up period, no treatment with FOL-005 has occurred. The results show that the safety profile is very good. Approximately 2% of the growth of hair growth remains after three months without treatment, which should be compared to an increase of approximately 8% immediately after treatment with FOL-005. This confirms that Follicum's drug candidate FOL-005 is well tolerated and has a treatment effect that stimulates hair growth.
In the completed Phase I / IIa study, FOL-005 has been injected on the front of the thighs. Nevertheless, Follicum's substance has shown efficacy results that are in line with what has been published in Phase III studies for existing preparations on the market. The fact that the FOL-005 in the first clinical trial showed statistically-assured effects on hair growth, without the study being primarily designed for this, is very interesting.
Preparations for study on scalp
The next step in the development of the drug candidate FOL-005 is to carry out a study similar to the recent study but on scalp, which is the intended use of FOL-005 where the ambition is to further clarify the effect of FOL-005. In parallel, work on the development of a user-friendly formulation proceeds according to plan. When an optimized formulation has been developed, the company intends to launch a more comprehensive impact study on scalp.
CEO Jan Alenfall comments
- We are excited to report the clinical trials of the clinical phase I / IIa three-month follow-up showing that FOL-005 is well tolerated and had positive effects during the months undergoing treatment. The final results that show that only a portion of the hair-stimulating effect remained when participants did not receive our treatment were expected. The clinical study has shown that treatment with FOL-005 is safe and provides a good effect, despite the fact that we have not developed a final formulation and do not have a complete dose. Overall, these results provide a good reason for the continued development of FOL-005 in the next step of product development.