Com­pass Path­ways' Phase IIb psilo­cy­bin tri­al shows re­duced de­pres­sion symp­toms

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.”

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

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 cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

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.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

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.