Funds to advance Phase 2 trials of MapLight Therapeutics lead program for schizophrenia and Alzheimer’s disease psychosis

San Francisco, October 30, 2023.- Novo Holdings, a leading life science investor, today announced that it co-led an oversubscribed Series C financing round in MapLight Therapeutics, to advance transformative treatments for neuropsychiatric and neurological conditions.

New investors Novo Holdings, 5AM Ventures, Cowen Healthcare Investments, and others joined MapLight’s existing syndicate in the financing. With this round of funding, MapLight will advance ML-007C-MA, a novel M₁/M₄ muscarinic agonist agent combined with a precision matched peripheral muscarinic antagonist, into Phase 2 trials for schizophrenia and Alzheimer’s disease psychosis in 2024, and enable continued progress on the company’s other pipeline programs.

“MapLight is advancing what we believe will be the best-in-class muscarinic agent for difficult-to-treat disorders including schizophrenia and Alzheimer’s disease psychosis. Schizophrenia alone affects around 3 million adults in the U.S. and 1 percent of the worldwide population,” said Jim Trenkle, Ph.D., MBA, Partner in the Venture Investments group at Novo Holdings. “We are delighted to partner with a strong group of existing and new investors to catalyze significant advancements in the fight against these important central nervous system disorders, and to support the talented, dedicated team at MapLight.”

In connection with the financing, Jim Trenkle, Ph.D., MBA, Partner in the Venture Investments group at Novo Holdings will join the MapLight Therapeutics Board of Directors.

Transformative therapies for diseases with high unmet need
If approved, MapLight’s ML-007C-MA would be one of the earlier market entrants of a new class of antipsychotic, the muscarinic receptor antipsychotics. The muscarinic receptor antipsychotics improve psychotic symptoms via a distinct mechanism of action to currently approved atypical antipsychotics.

Today schizophrenia is treated with dopaminergic atypical antipsychotics with limited success and significant side effects: 30% of people with schizophrenia achieve no response to treatment and another 30% only achieve a partial response. This leaves a substantial portion of the population with urgent unmet needs.

ML-007 is a muscarinic receptor agonist designed to target M1 and M4 muscarinic receptor subtypes with no direct activity on dopamine receptors. Deficits in M1 receptors are linked to schizophrenia, and M1 receptors directly regulate neural circuits known to be important in both psychosis and cognition. M4 receptors regulate a complementary neural circuit known to be important in psychosis. ML-007C-MA unlocks the full therapeutic potential of ML-007, an M1/ M4-preferring muscarinic agonist, by pairing it with a precision-matched muscarinic antagonist to block peripheral side effects.

MapLight’s ML-007C-MA is also being developed as a potent treatment for Alzheimer’s disease psychosis. Currently more than 40% of people with Alzheimer’s disease will experience delusions and hallucinations as part of the disease, a condition known as AD psychosis. There is no FDA approved medication for the treatment of this condition. Atypical antipsychotics are typically used off-label in elderly patients with the condition, a group for whom atypical antipsychotics present concerning safety issues.

In addition to ML-007C-MA, MapLight currently has two other products in clinical development: ML-007 is under study for dyskinesia, and ML-004, a 5HT-1b agonist is currently in Phase 2 for social communication deficits in patients with autism spectrum disorder. MapLight’s pipeline of preclinical assets include ML-016, a GPR-6 antagonist under study for both Parkinson’s disease and depression, and ML-009, in development to treat hyperactivity and impulsivity.

“MapLight has built a diverse pipeline of innovative neuroscience therapeutics targeting a spectrum of Central Nervous System (CNS) disorders where the challenges faced by patients and families are significant and the unmet need is high. This financing will fuel the important clinical development necessary to bring these innovative therapies to patients,” said Christopher Kroeger, M.D., MBA, Chief Executive Officer, and Founder. “The enthusiasm and continued support of our existing investors, combined with the significant commitment from this new slate of top tier funds, provides validation for our circuit-based discovery platform approach, the quality of our clinical assets, and the strong capabilities of our team.”

About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development.
As of year-end 2022, Novo Holdings had total assets of EUR 108 billion.