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.”

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.