Neuroelectrics co-founders Ana Maiques and Giulio Ruffini

Per­son­al­ized elec­tric stim­u­la­tion for epilep­sy, de­pres­sion? Morn­ing­side bets $17.5M on an idea dat­ing back to Ro­man Em­pire

In his 46 AD com­pendi­um of med­ical treat­ments, Scri­bo­nius Largus, the court physi­cian to the Ro­man em­per­or Claudius, de­scribed a pe­cu­liar way to re­lieve headache.

Place a live tor­pe­do fish — the black, flat, disc-look­ing fish al­so known as elec­tric ray — on the place which is in pain, he in­struct­ed, un­til the pain ceas­es and the part grows numb. The pur­port­ed ef­fect? It would “im­me­di­ate­ly re­move and per­ma­nent­ly cure a headache, how­ev­er long-last­ing and in­tol­er­a­ble.”

Neu­rostim­u­la­tion resur­faced as a vi­able med­ical tool in the 19th cen­tu­ry af­ter sci­en­tists fig­ured out ways to pro­duce and de­liv­er elec­tric cur­rents in a re­li­able man­ner. Now, Morn­ing­side Ven­tures is putting $17.5 mil­lion be­hind a next-gen, per­son­al­ized take on the idea that of­fers hope of at-home ther­a­pies for pa­tients with CNS con­di­tions, such as epilep­sy and de­pres­sion, that are re­frac­to­ry or re­sis­tant to treat­ment.

Neu­ro­electrics is no start­up. The first stage of its life took about a decade, when the com­pa­ny sus­tained it­self by sell­ing its non-in­va­sive de­vice — a head scarf cov­ered in elec­trodes and wires — to re­searchers around the world, get­ting to a point where they earned $5 mil­lion rev­enue last year.

They al­so man­aged to start some pi­lot clin­i­cal stud­ies and with Morn­ing­side’s back­ing, they ex­pect to fin­ish the piv­otal leg of the epilep­sy tri­al and pave the way to com­mer­cial­iz­ing the de­vice as a treat­ment.

“Ul­ti­mate­ly I think we will be­come a huge brain da­ta com­pa­ny,” Ana Maiques, co-founder and CEO, told End­points News from Barcelona, where the de­vices are man­u­fac­tured. The clin­i­cal work, mean­while, takes place in Boston.

Every time a new pa­tient tries Neu­ro­electrics’ de­vice, she ex­plained, the com­pa­ny gets an MRI and EEG so that an 18-per­son team can get to work build­ing a 3D mod­el. From there, they de­vise a per­son­al­ized pro­to­col spec­i­fy­ing how many elec­trodes and how much cur­rent they need and where.

In the pi­lot epilep­sy study in­volv­ing 20 pa­tients, the ther­a­py re­port­ed­ly led to 44% re­duc­tion in seizures com­pared to base­line, meet­ing the bench­mark with im­plantable neu­rostim­u­la­tion de­vices such as va­gus nerve stim­u­la­tion, Maiques said.

There are lim­its to where the tech­nol­o­gy can go, she ad­mit­ted. It will like­ly have lit­tle ef­fect, for in­stance, in dis­eases like Parkin­son’s where the source of tremor lies deep in the brain. But if Neu­ro­electrics proves its de­vices ef­fec­tive in even a frac­tion of the in­di­ca­tions they are go­ing af­ter — Alzheimer’s, autism, AD­HD — they could be open­ing up a no­to­ri­ous field that’s blown up count­less drug de­vel­op­ment ef­forts.

“With these tech­nolo­gies, we have a unique op­por­tu­ni­ty to pro­vide a nov­el treat­ment but to learn day af­ter day what is the im­pact of these treat­ments in re­al time,” she said.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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