Saniona har utsett Pierandrea Muglia, M.D., till Chief Medical Officer, med över tre decenniers erfarenhet från internationella läkemedels- och bioteknikbolag och neurovetenskaplig forskning. Sedan han klev in som styrelseledamot 2023 har Muglia sett bolagets pipeline och partnerskap utvecklas, inklusive avtalet på 610 MUSD med Acadia Pharmaceuticals. Nu ska han leda Sanionas kliniska och regulatoriska arbete när tre kandidater förbereds för fas II-studier. Vi kontaktade Muglia för att ta del av hans visioner.

Sanionas nye CMO Pierandrea Muglia har en bakgrund som VP och Head of Neurology Early Clinical Development på UCB, CMO på Handl Therapeutics samt grundare och vd för GRIN Therapeutics. På GRIN byggde han ett bolag till klinisk fas och säkrade finansiering för ett framgångsrikt proof of concept, som nu leder till starten av en fas III-studie av en småmolekyl riktat mot en svår neurologisk utvecklingsstörning. Med över 100 publikationer med hög impaktfaktor spänner hans karriär över både akademi och industri.

I en kommentar säger vd Thomas Feldthus: “Pierandrea’s extensive expertise in clinical development is invaluable as Saniona advances its pipeline for the treatment of neurological and psychiatric diseases. His leadership will be instrumental in driving the clinical strategy.”

Siktar på att upprepa Acadia-avtalet

Sanionas pipeline fokuserar på epilepsi och neurologiska sjukdomar, med SAN711 (fas II-klar för essentiell tremor), SAN2219 (akuta upprepade anfall) och SAN2355 (fokala anfall från Kv7-programmet). Dessutom har bolaget utlicensierat tesofensine till Medix för behandling av fetma, med möjligt godkännande i Mexiko under 2025.

I november förra året ingick Saniona ett partnerskap med Acadia Pharmaceuticals för att utveckla och kommersialisera SAN711. Avtalets totala potentiella värde är 610 MUSD, inklusive en förskottsbetalning på 28 miljoner USD. Under 2025 siktar man på att upprepa Acadia-avtalet för en av sina tillgångar och använda medlen för att föra de andra till proof of concept. I sin nya roll på Saniona ska Dr. Muglia övervaka och stärka bolagets kliniska utveckling och regulatoriska funktioner och därmed befästa positionen inom neurologi.

Frågor till CMO

BioStock kontaktade Dr. Pierandrea Muglia för en kommentar.

How will your GRIN Therapeutics experience shape your approach as CMO of Saniona?

– My experience at GRIN Therapeutics was all about being innovative and thinking holistically. We worked on developing a small molecule that targets the underlying cause of a severe neurodevelopmental disorder, with the goal of addressing the broad range of symptoms it causes. That approach taught me a few critical lessons that I’m bringing with me to Saniona.

– First, we need a strong scientific rationale backed by solid data. The connection between a drug candidate’s mechanism of action and the underlying biology of the disease has to be clear and robust. That’s the foundation of everything.

– Second, we have to focus on areas of high unmet need where there’s a real potential to transform the standard of care. Drug development is costly and complex, so it’s essential to invest resources in candidates that offer significant benefits over what’s already available.

– Third, clinical program sophistication is key. It’s about designing rational drug development programs and, especially in CNS disorders, establishing biomarkers that can demonstrate early on whether a compound is doing what it’s supposed to do at the brain level. Being able to detect relevant pharmacology with achievable doses makes all the difference. 

What’s the biggest strength in Saniona’s current pipeline?

– The biggest strength of Saniona’s pipeline is the combination of the potential to address high unmet medical needs and a high probability of success. What’s exciting is that all the compounds approaching clinical development have well-designed biomarker plans for both target engagement and early proof of concept.

– And as Sir James Whyte Black, the Nobel Prize winner, famously said: “The most fruitful basis for the discovery of a new drug is to start with an old drug.” That principle applies well here.

– Saniona’s pipeline represents years of dedication from talented chemists and biologists who, building on existing knowledge around molecules targeting known targets like GABA, have created innovative molecules with the potential to be truly transformative. That’s why I’m so enthusiastic about this new role and the company’s future.

How do you plan to leverage biomarkers in clinical trials?

– What’s remarkable about Saniona’s assets is that we have the tools to make early-stage development highly efficient. For all the compounds we’re preparing for clinical studies, we can use available PET imaging tracers to link doses with target engagement. We will also rely on established electrophysiology paradigms to detect relevant pharmacology.

– Having these tools in place gives us a fundamental advantage—it allows us to identify optimal doses for first-in-patient studies much earlier and more effectively than usual. This approach significantly de-risks the development process and maximizes the likelihood of success.

Having served on the board since 2023 and contributed to securing the Acadia partnership, how do you foresee striking a similar deal?

– The Acadia deal was a testament to the quality of molecules that the Saniona team continues to produce, especially considering the challenging economic environment we’re all navigating.

– The exciting part is that the other assets in the pipeline come from the same “production line.” They are high-quality compounds with clear value propositions and the potential to address multiple indications. We’re confident that as we continue to advance these assets, the interest from potential partners will only grow. So, yes, more deals are definitely on the horizon. 

What’s your long-term vision as CMO?

– Saniona has already established itself as a strong platform and a preferred partner. Now, the next step is to strengthen our development capabilities and progress our assets further into clinical stages.

– The potential of Saniona’s assets positions the company to become a leader in the CNS biotech space—one that can truly compete with major players internationally. I see us building a pipeline that not only attracts partnerships but also brings real, transformative therapies to patients who desperately need them. That’s the ultimate goal.

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