Neurosterix debuts with $63M to bankroll muscarinic modulator for neuropsychiatry
03 Apr 2024
AcquisitionPhase 1Drug ApprovalPhase 2
Neurosterix on Wednesday announced a $63-million series A to develop allosteric modulator therapeutics that can overcome the burdens of traditional drugs for patients with underserved neurological disorders. The round was led by Perceptive Xontogeny Venture Fund II, with participation from Perceptive Life Sciences Fund and Acorn Bioventures.
The capital will help support the Addex Therapeutics spinout's lead programme, a muscarinic M4 positive allosteric modulator (M4 PAM) for schizophrenia, as it advances towards clinical studies. CEO Tim Dyer told FirstWord that IND-enabling studies are set for later this year, with a potential advance into Phase I in the second half of 2025.
Decades without neuro innovation
Addex, which will retain partnered programmes with Johnson & Johnson and Indivior, has a 20% stake in Neurosterix. But the bulk of its employees, including Dyer, are heading over to Neurosterix and are squarely focused on advancing M4 PAM.
Allosteric modulators bind receptor sites distinct from the main active site, potentially offering greater selectivity and control over biological pathways, and ultimately better safety and efficacy. "There really hasn't been a genuinely new mechanism of action in neuropsychiatry for a very, very long time, for decades," Fred Callori, managing director at Perceptive Advisors and board chairman at Neurosterix, said in an interview with FirstWord.
"This M4 class of drugs are demonstrating really increased potential in schizophrenia…with a very compelling safety profile compared to the traditional antipsychotics. We know that the patient unmet need is enormous, so the ability to kind of impact patients' lives is very material here," he added.
Building on earlier entrants
Neurosterix is entering a space being reshaped by a pair of recently acquired muscarinic frontrunners. Last year, Bristol Myers Squibb purchased Karuna Therapeutics for $14 billion and AbbVie acquired Pfizer spinout Cerevel Therapeutics for $8.7 billion – both centred on muscarinic receptor modulators for neuropsychiatric conditions like schizophrenia (see – KOL Views Q&A: Leading psychiatrist sees a muscarinic revolution coming in schizophrenia and beyond).
The startup's lead programme is similar to Cerevel's investigational antipsychotic emraclidine, which is also a selective M4 receptor PAM. Emraclidine is currently in mid-stage testing for schizophrenia, and is also being evaluated in Phase I study to support a potential Alzheimer's disease psychosis programme. "We're catching up, should I say, with Cerevel," Dyer said.
Meanwhile, Karuna's lead asset KarXT (xanomeline-trospium), an oral M1/M4-preferring muscarinic agonist, could reach the market first pending an FDA decision expected in September to treat schizophrenia.
However, there is no concern over at Neurosterix about coming in a little later in the game than others have. "We actually see that as an advantage," said Callori. "We think we can be differentiated, but even without that, the size of this market and the needs are really set up to allow for multiple drugs to benefit these patients."
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