Follicum Ab Reports Top-line Data From First-in-man Scalp Study
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ollicum AB (“Follicum” or “Company”), a biotech company that develops new drugs in two areas, hair loss and diabetes, today reports top-line data from the first phase IIa study with FOL-005 for the treatment of hair loss on scalp in patients. The phase IIa study examined the safety and therapeutic effect of different doses of the drug candidate FOL-005, administered as injections into the scalp 3 times per week. The results confirmed that the treatment was safe with minimal side effects reported. Furthermore, increased hair growth was measured at the highest dose. Follicum will now follow up with a clinical efficacy study using a topical formulation of FOL-005.
In the study, hair growth (primary endpoint) increased on average by 7 hairs per cm2 and the increase was borderline statistically significant compared to baseline (p = 0.078). There was no statistically significant difference for placebo when compared to baseline. The study was designed to measure the effect after treatment vs. baseline (the individual’s starting value) and not vs. placebo. A clear positive effect was also shown in the number of hairs in growth phase, another very important parameter for hair growth. At the highest dose, a marked, 11% (median) increase in the number of hair follicles in growth phase was observed. Furthermore, the ratio between the number of hair in the growth phase to those in the dormant phase increased by 18% (median), while the corresponding number for placebo was minus 16% (median). This difference reinforces the other results, which taken together indicate that FOL-005 is a promising treatment for alopecia (hair loss), although the dose and treatment length will probably need to be optimized to obtain maximum effect. In the case of the placebo, the majority of the parameters showed changes in the opposite direction, i.e. weakened hair growth. The next step for the company is to prepare for a clinical study evaluating the effect of a topical formulation of FOL-005, where dose, dosing frequency and treatment duration will be optimized. In parallel, the company will focus on finding a suitable partner for further development of FOL-005.
In the study, hair growth (primary endpoint) increased on average by 7 hairs per cm2 and the increase was borderline statistically significant compared to baseline (p = 0.078). There was no statistically significant difference for placebo when compared to baseline. The study was designed to measure the effect after treatment vs. baseline (the individual’s starting value) and not vs. placebo. A clear positive effect was also shown in the number of hairs in growth phase, another very important parameter for hair growth. At the highest dose, a marked, 11% (median) increase in the number of hair follicles in growth phase was observed. Furthermore, the ratio between the number of hair in the growth phase to those in the dormant phase increased by 18% (median), while the corresponding number for placebo was minus 16% (median). This difference reinforces the other results, which taken together indicate that FOL-005 is a promising treatment for alopecia (hair loss), although the dose and treatment length will probably need to be optimized to obtain maximum effect. In the case of the placebo, the majority of the parameters showed changes in the opposite direction, i.e. weakened hair growth. The next step for the company is to prepare for a clinical study evaluating the effect of a topical formulation of FOL-005, where dose, dosing frequency and treatment duration will be optimized. In parallel, the company will focus on finding a suitable partner for further development of FOL-005.
- Reaction score
- 707
Dissapointing results or am i missing something?
- Reaction score
- 137
P = .078 is not significant. At all.
Not impressed.
Not impressed.
CEO Jan Alenfall comments:
“We are very pleased to have completed this phase IIa clinical study that has shown that the treatment is safe and despite the limited number of patients, also shows a good effect on hair growth. The highest dose showed that the treatment resulted in both increased hair growth and a substantial increase in the number of hair follicles in growth phase. This is of great importance for alopecia patients who have a reduced hair growth period. The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can “awaken” dormant hair follicles. In the placebo group, the proportion of hair follicles in growth phase decreased. Overall, the results provide very important guidance for planning the new efficacy study with a topical formulation where dosage and dosing frequency will be studied. We are now looking forward to starting a new study on the scalp with a larger number of patients to overcome the issues with large, individual variations in a small patient cohort.”
Source: http://follicum.com/follicum-ab-rep...n-scalp-study-with-fol-005-against-hair-loss/
“We are very pleased to have completed this phase IIa clinical study that has shown that the treatment is safe and despite the limited number of patients, also shows a good effect on hair growth. The highest dose showed that the treatment resulted in both increased hair growth and a substantial increase in the number of hair follicles in growth phase. This is of great importance for alopecia patients who have a reduced hair growth period. The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can “awaken” dormant hair follicles. In the placebo group, the proportion of hair follicles in growth phase decreased. Overall, the results provide very important guidance for planning the new efficacy study with a topical formulation where dosage and dosing frequency will be studied. We are now looking forward to starting a new study on the scalp with a larger number of patients to overcome the issues with large, individual variations in a small patient cohort.”
Source: http://follicum.com/follicum-ab-rep...n-scalp-study-with-fol-005-against-hair-loss/
I read this and hard to make a sensible assessment, the median regrowth is 11% and unfortunately only has a p-value of 0.078 ... at the same time, the study only lasting 3 months with a relatively low number of patients and an unoptimized dose . At the same time, they have increased anagen phase by 18% in three months! Overall, because they have no side effects, does this feel relatively promising or?
Well, the good news is that they’re still testing, they’re going forward with a new topical, and they’re using varying dosages to assess safety. The higher dose yielded the best results, and Jan said there were no safety concerns with that. Hopefully they’ll go on seeing what dose is optimal and safe.
- Reaction score
- 686
Exactly phase 2 AND they keep moving on whti a topical from now on. I think a topical will be worse than an injection effectivness wise...
They do at least one more phase 2 trial then a phase 3 trial and they are a small company which needs funding. By the time they could launch their product there will be way better treatments so i don t have the slightest hope they will process till launch... Nobody will fund them with this kind of results and when tsuji, samumed histogen follica maybe even breezula are all availabel at that time...
Bro no offense, but if you have been around for the last 5 years you would know that aint sh*t promised. Better for these guys to try and do everything to get to market because the chances of all that other sh*t failing are 75% imho.
I don’t Know the full details of the study but Follicum is not like Fidia so you could email them and probably get an answer. Btw what do you guys think of the result. I mean I would like the p-value to be less than 0,05 but it’s only three months with a limited number of people trying this with 3 applications a week. Also the stock is now oversold so this opens up for great profits down the line.
- Reaction score
- 288
http://follicum.com/interview-folli...ing-and-motivate-us-to-start-a-topical-study/
Interview with Follicums CEO about the study
Interview with Follicums CEO about the study
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