Martin Tolar, Alzheon CEO

In one-year up­date, Alzheon goes big talk, but shows off lit­tle clin­i­cal da­ta

As Bio­gen pulls its glob­al Aduhelm ap­pli­ca­tions left and right, Alzheon — an­oth­er small­er Mass­a­chu­setts-based biotech — claims (again) it has “in­dus­try-lead­ing” da­ta on its Alzheimer’s drug. In a field lit­tered with drug fail­ures, any clin­i­cal ben­e­fit would be a ma­jor break­through. But on that front, Alzheon came up emp­ty-hand­ed.

In a one-year up­date on its Phase II tri­al, Alzheon said that in 75 pa­tients who took its oral drug ALZ-801 twice a day, it ob­served a 41% re­duc­tion from base­line in lev­els of phos­pho­ry­lat­ed tau, or p-tau, a brain pro­tein which builds up in Alzheimer’s dis­ease. Alzheon al­so said that its drug re­duced the ra­tio of p-tau and a com­po­nent of amy­loid plaques, Aβ42, by 37%.

Alzheon’s Phase II tri­al en­rolled 84 pa­tients with ear­ly Alzheimer’s who have ei­ther one or two copies of a spe­cif­ic geno­type — APOE4 — which is a ge­net­ic risk fac­tor for Alzheimer’s.

But no­tably, Alzheon pro­vid­ed no clin­i­cal da­ta in its one-year up­date. It on­ly said that mem­o­ry test scores were “main­tained above base­line at 1-year time­point,” but failed to pro­vide any spe­cif­ic num­bers or sta­tis­tics. Alzheon did not re­spond to re­quest for com­ment at the time of pub­li­ca­tion.

In its six-month study up­date in Feb­ru­ary, Alzheon like­wise did not give ex­act num­bers on mem­o­ry test da­ta, say­ing on­ly that there was an im­prove­ment from base­line at 26 weeks with a p-val­ue of 0.002.

Alzheon’s drug, like oth­ers be­fore it, is built on the amy­loid hy­poth­e­sis — the idea that Alzheimer’s can be treat­ed by re­mov­ing the brain pro­tein plaques that are a sig­na­ture of the dis­ease.

But that hy­poth­e­sis has con­tin­u­ous­ly floun­dered in clin­i­cal tests. Aduhelm’s con­tro­ver­sial ap­proval lies in two sup­pos­ed­ly iden­ti­cal­ly-de­signed Phase III stud­ies that had con­flict­ing clin­i­cal re­sults.

In April, Alzheon raised $50 mil­lion as part of its Se­ries D. The big test for Alzheon is its NIH-fund­ed Phase III study on ALZ-801 — a 300-pa­tient study in which suc­cess rides on re­al clin­i­cal im­prove­ment.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.