Brian Harris, MedRhythms CEO

Bio­gen taps dig­i­tal ther­a­peu­tics biotech for mu­sic-based ther­a­py to help peo­ple with MS im­prove their walk­ing

In the past decade, dig­i­tal health­care has been get­ting big — and now it’s sad­dling up with Big Phar­ma. As the lat­est phar­ma to take a swing at dig­i­tal ther­a­py, Bio­gen has li­censed an in­ves­ti­ga­tion­al pre­scrip­tion ther­a­py meant to help pa­tients with mul­ti­ple scle­ro­sis (MS) im­prove their gait from MedRhythms, a Port­land, ME-based biotech.

For the ther­a­py, dubbed MR-004, MedRhythms is re­ceiv­ing $3 mil­lion up­front and can get up to $117.5 mil­lion more in down­stream mile­stones, ac­cord­ing to the press re­lease.

The dig­i­tal ther­a­py “us­es a com­bi­na­tion of sen­sors, soft­ware, and mu­sic” to im­prove walk­ing for peo­ple with MS. Gait prob­lems are one of the most com­mon symp­toms of MS, and cur­rent treat­ment op­tions in­clude phys­i­cal ther­a­py as well as an oral med­ica­tion known as Ampyra (dal­fam­pri­dine), which aims to help the nerves con­duct sig­nals through the body.

Mar­tin Dubuc

“As part of our as­pi­ra­tion in dig­i­tal health, to­geth­er with MedRhythms we aim to ad­vance a new, in­no­v­a­tive treat­ment op­tion for peo­ple liv­ing with MS that may help ad­dress walk­ing im­pair­ment, a com­mon is­sue that im­pacts their over­all qual­i­ty of life,” Bio­gen’s head of dig­i­tal health Mar­tin Dubuc said.

While the dig­i­tal MS ther­a­py is still in fea­si­bil­i­ty stud­ies, if it reach­es ap­proval, it would be the first pre­scrip­tion dig­i­tal ther­a­py for a con­di­tion that af­fects many pa­tients who have MS.

Bio­gen is not the on­ly phar­ma com­pa­ny try­ing to get in­to dig­i­tal ther­a­peu­tics. Just last week, Sanofi penned a mul­ti-year deal with Dar­i­o­Health, which is push­ing AI-based apps for man­ag­ing a va­ri­ety of chron­ic health con­di­tions.

MedRhythms’ ap­proach fo­cus­es most­ly on pre­scrip­tion treat­ments for con­di­tions re­lat­ed to neu­ro­log­i­cal dis­eases, lever­ag­ing a form of mu­sic ther­a­py known as “Rhyth­mic Au­di­to­ry Stim­u­la­tion.” The com­pa­ny al­so boasts a dig­i­tal walk­ing ther­a­py for pa­tients re­cov­er­ing from stroke, which re­ceived a break­through de­vice des­ig­na­tion from the FDA in 2020.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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