Alopecia - Clinical Trial Results

Three companies have released phase 3 clinical results with their respective drugs for Alopecia, and plan to file for FDA approval for this unmet need. Graph below of the clinical results, showing what each companies highest dose achieved in their phase 3.                                                                                        

The above chart shows, the effectiveness that each drug to the SALT 20 scoring criteria. A lower SALT from baseline signifies that there was more hair growth while on therapy. The highest percentage of test participants that achieved under or equal to the SALT 20 score, was Concert's CTP-543 12mg, with 38% and 41% of patients scoring under, in two phase 3 clinical trials. The hope is that those suffering from Alopecia will have a selection of at least two effective drugs for their disease. Thank you for reading.

Alopecia Areata - Long Term Efficacy

There's not an FDA approved drug, for unmet medical need Alopecia available for patients at this time. Both Lilly (Baricitinib) and Concert (CTP-543) have now released long-term (52 week) Alopecia efficacy data, using the SALT score of equal to, or less than a score of 20. Note, that a SALT score 0f zero is considered a full head of hair. So the lower the score the more hair growth has been achieved while on therapy. Below is a chart of the percentage of patients achieving the SALT score of equal to or below 20, in each Lilly and Concert's long-term clinical trials.

From the chart data above, Concerts CTP-543 has 57% of patients achieving SALT 20 or lower in their open label 52 week study. The Lilly press release of their results, can be found here Lilly. Concert’s information is located at their website under Scientific Presentations. There's a strong possibility that one, or both of these oral drugs will get approved, over the next two years. Thank you for reading. 

Alopecia Areata - CTP-543, Baricitinib, Ritlecitinib

Of the three companies addressing the unmet medical need that exits for Alopecia Areata, both Concert Pharmaceuticals, and Lilly, have officially released SALT 20 scores. With both companies completing either phase 2 or phase 3 clinical trials, we can make comparison's from the information the companies have released to the public. Lilly has completed two phase 3's Brave-AA1, Brave-AA2 with drug Baricitinib, and Concert has completed a phase 2 with CTP-543. Both have initiated two dosing arms in their trials.

Without considering safety issues for either CTP-543, Baricitinib or Retlecitinb at this time, CTP-543's 12 mg dose appears to have the strongest effect for patients with 42% achieving SALT equal or below a score of  20.

Pfizer has released Ritlecitinib phase 2/3 clinical data Abstract 41, but did not break out the SALT 20 scores, but has issued long-term 48 week results. Below is a comparison of Ritlecitinib 48 week and CTP-543 52 week (Mean SALT Score) results that the companies have released to the public. 

Note that a SALT score of zero is a full head of hair. So the lower the SALT score from baseline, the more hair growth that has occurred. The baseline score (SALT 88.1) was derived from Pfizer's phase 2 part of the phase 2/3 clinical trial. Concert has used the 12 mg dose from two clinical trials to derive a baseline average score of SALT 86.5. Thank you for reading.

Patent Expiration Dates

A drug's patent is of extreme importance to the company that has developed the drug, and competitors looking for acquisition.  This is a running patent list, as new drugs become of interest.  The typical drug patent extends for 20 years from the priority date, once the patent is approved.  After 20 years, and any additional patent extensions, generic companies are able to replicate, and sell the drug at a very high discount to the expired patented drug.

AVP-923 US 2026                                                          

AVP-923 EU 2023

AVP-786 US 2030
AVP-786 EU 2028
AXS-05  US 2040
AXS-07 US 2036
D-Baricitinib US (August 2032)
D-Baricitinib EU xxxx
Baricitinib US 2028
CTP-543 US 2037
CTP-543 EU xxxx
Ruxolitinib US (Dec 2027)
CTP- 656 US (May 2031)
CTP- 656 EU xxxx
Kalydeco US 2027
Kalydeco EU 2025
CTP-692 2038
CTP- 730 US 2030
CTP- 730 EU 2030
Otezla US 2024 (pending through 2028)
Otezla EU 2028
GLPG0634  US (June 2029)
GLPG 1837  US 2034
ITI- 007 US 2028
JZP-386 US, EU, JP (2030-2032)
Xyrem  2019-2024
MIN-101 GR US 2035
D-Momelotinib US (Jan 2033)
D-Momelotinib EU  xxxx
Momelotinib US (March 2027)
Nuplazid US 2028
Nuplazid EU 2025
Rexulti US (February 2027)

Rexulti EU (December 2026)
SAGE-217 US  April 2034
SAGE-217 EU April 2034
SAGE-547 US  to 2033 - 2037
SAGE-718 US  Sep 2032 or Oct 2037