Roche shelved these psychiatry drugs. So its former head of neuro cooked up some new plans — and raised $59M for his startup
As the former head of neuroscience product development at Roche for a decade, George Garibaldi can personally vouch for the quality of what the Swiss pharma giant does. But having worked on psychiatric disorders, he also knew way too well the downside of a field where animal models were a poor prediction of how drugs would perform in humans.
So when he caught word that Roche was putting part of its psychiatry pipeline on the shelf, Garibaldi, by then running his own consultancy, immediately took interest in licensing those compounds. He’d go down a slightly different direction, at a startup eventually named Noema Pharma.
“The story of Noema is very similar to Actelion in terms of how it started,” CEO Luigi Costa told Endpoints News, referring to the biotech spun out from Roche with its top cardiovascular researchers and programs.
In particular Sofinnova Partners, which had backed Actelion’s launch round and since started two other companies leveraging a similar model with Roche, helped build Noema from scratch. Managing partner Antoine Papiernik invited Costa to take it on as his first entrepreneur-in-residence project, and they put a plan together with Garibaldi.
Sofinnova is also co-leading a $59 million Series (CHF$54 million) Series A with Polaris Partners. Roche also chimed in, alongside Gilde Healthcare, Invus and BioMed Partners.
The funding should take the biotech into readouts of three Phase IIb studies in orphan neurological diseases: seizures in tuberous sclerosis complex, trigeminal neuralgia and Tourette syndrome.
NOE-101, a negative modulator of mGluR5, covers the first two indications while a second, NOE-105, is designed to reduce the involuntary tics in Tourette patients by inhibiting PDE10A.
Both of those candidates were already in Phase IIb at Roche for psychiatric disorders (a previous effort to develop an mGluR5 drug for Fragile X had floundered). The other two compounds are slated for Phase II studies later in 2021.
Instead of modulating behavior, Noema is trying to drive changes in tangible symptoms that have a big impact on daily functions.
“We’re directing them to more neurology, where it’s more diseases with clear symptoms that you and I can see,” he said. “So seizures, something that we can see. But in psychiatry, you don’t see what people think.”
That doesn’t necessarily make it easier. Yet somewhat serendipitously, Garibaldi said, between 2017 and 2019 a host of scientific papers published independently by labs had provided evidence that inspired them to select the lead indications with confidence. Some, for instance, suggested that blocking the mGluR5 receptor could reduce tumor growth as well as seizures, the two defining features of TSC. Another showed that NOE-101 goes directly into the nucleus of spinal cord cells, which is key for chronic pain.
John Kemp, who had recently left his role leading Janssen’s neuroscience discovery, joined early as CSO. The internal team at Noema totals only six staffers — a size that allows them to be nimble and flexible.
The same philosophy is in play as they tailor clinical trials against the backdrop of Covid-19. While having oral, small molecule drugs to administer already avoids some headaches, Noema is still playing safe. The global program will start, for now, in Australia, with an eye to minimizing the number of visits to clinical sites and maximizing remote monitoring.
If the data bear out — and we should have a first look by the end of next year — Garibaldi said Noema won’t “exclude in the long term going back to Roche” for more in-licensing deals.