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.”

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Not even two months after reporting a Phase II fail for its lead drug candidate, Stealth BioTherapeutics is now being eyed for a potential acquisition, with one firm wanting to take it private.

Stealth reported Monday that Morningside Venture Investments sent Stealth’s board of directors a non-binding preliminary proposal to acquire all outstanding shares not yet owned by Morningside for 2.6 cents per share and 31.3 cents per ADS.