UK biotech Com­pass Path­ways re­vealed this morn­ing that they reached the pri­ma­ry end­point in a Phase IIb clin­i­cal tri­al of psilo­cy­bin ther­a­py.

In the ran­dom­ized, con­trolled and dou­ble-blind tri­al, in­ves­ti­ga­tors looked at a sin­gle dose of Com­pass’s in­ves­ti­ga­tion­al psilo­cy­bin ther­a­py COMP360 for treat­ment-re­sis­tant de­pres­sion in 233 pa­tients, giv­en along­side psy­cho­log­i­cal sup­port. The tri­al, which had all pa­tients stop­ping an­ti­de­pres­sants be­fore par­tic­i­pat­ing, com­pared two ac­tive dos­es of COMP360, 25mg and 10mg, against a com­para­tor 1mg dose.

The re­sults showed that there was a “sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly rel­e­vant re­duc­tion in de­pres­sive symp­tom sever­i­ty af­ter three weeks,” ac­cord­ing to a Com­pass state­ment.

While the can­di­date was gen­er­al­ly well tol­er­at­ed, 179 pa­tients re­port­ed at least one ad­verse event — the most com­mon be­ing headaches, nau­sea, fa­tigue and in­som­nia. There were 12 pa­tients who re­port­ed more se­ri­ous ad­verse events, such as sui­ci­dal be­hav­ior, in­ten­tion­al self-in­jury, and sui­ci­dal ideation.

The goal of the tri­al was to find the ap­pro­pri­ate dose for a larg­er, piv­otal Phase III tri­al, which the biotech ex­pects to be­gin some­time next year.

George Gold­smith

“We set out to ex­plore the safe­ty and ef­fi­ca­cy of COMP360 psilo­cy­bin ther­a­py in treat­ment-re­sis­tant de­pres­sion, through a rig­or­ous and large-scale tri­al, and to find an ap­pro­pri­ate dose to take to the next stage,” said Com­pass CEO George Gold­smith in a state­ment. “With these com­pelling da­ta, we will ur­gent­ly progress our clin­i­cal de­vel­op­ment pro­gramme and move clos­er to mak­ing this ther­a­py ac­ces­si­ble to pa­tients in need, if ap­proved.”

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