Stalicla’s series B adds $17.4M for trials in substance abuse disorders, ASD

Stalicla SA Secures $17.4 Million in Series B Funding to Advance Innovative Therapies

Subtitle: Funding Enables Progress in Treating Cocaine Misuse Disorder and Autism Spectrum Disorder

Date: Friday, Jan. 19, 2024

Source: BioWorld (©2024 BioWorld. Reprinted with permission from Clarivate.)

Stalicla SA Achieves First Close of $17.4 Million Series B Round for Therapeutic Development

BioWorld, the leading source for 30 years in reporting on the evolution of groundbreaking human therapies, proudly announces the successful completion of the first close of Stalicla SA’s series B round, securing a substantial $17.4 million. This funding marks a crucial milestone for Stalicla as it prepares to advance its flagship programs, STP-7 and STP-1, targeting the treatment of cocaine misuse disorder and autism spectrum disorder (ASD), respectively.

Advancing STP-7 (Mavoglurant) for Cocaine Misuse Disorder

Stalicla SA, based in Geneva, Switzerland, disclosed that the series B funds will facilitate the commencement of a phase III trial for STP-7, also known as mavoglurant, a promising mGluR5 negative allosteric modulator. The U.S. National Institute on Drug Abuse (NIDA) will sponsor the phase III study, focusing on cocaine misuse disorder. However, completion of Chemistry, Manufacturing, and Controls (CMC) quality work is required before the study can initiate in 2025.

Precision Medicine Approach for ASD with STP-1

The series B financing empowers Stalicla to apply its precision medicine technique to STP-1 for ASD. This program involves endophenotyping patients with neurodevelopmental disorders (NDDs), aiming to identify a specific subgroup of ASD patients with similar molecular signatures. Over 1,000 patients are expected to be screened to select likely responders for inclusion in the upcoming phase II trial.

Endophenotyping: A Comprehensive Approach to NDDs

Stalicla’s endophenotyping approach transcends traditional diagnostic methods, utilizing metabolomics, whole genome sequencing, and RNA sequencing. By decoding underlying mechanisms and causal factors, Stalicla stratifies patient populations. This approach not only aids in identifying potential responders but also forms the basis for repurposing approved drugs or reconsidering those that showed promise in NDD clinical trials.

Mavoglurant’s Evolution: From NDDs to Substance Use Disorders

Originally intended for neurodevelopmental disorders, mavoglurant, in-licensed from Novartis AG, exhibited potential in treating cocaine addiction. Positive results from a 68-participant trial in cocaine use disorder paved the way for exploring its application in multiple substance use disorders. Lynn Durham, Founder and CEO of Stalicla, emphasized the non-specific nature of mavoglurant’s mechanism, targeting the mGluR5 receptor abundant in the brain’s reward system.

Exploring New Applications and Collaborations

Stalicla is actively engaged in discussions with government agencies to investigate mavoglurant’s use in alcohol use disorder and fentanyl addiction. With a robust safety profile from testing in over 1,800 clinical trial participants, Stalicla is poised for potential collaborations with government agencies to expand mavoglurant’s reach.

Strategic Moves and Future Prospects

Part of the series B funds will be allocated to position mavoglurant as a versatile technology platform applicable across neurological indications. Stalicla anticipates the need for additional funding to advance these indications, with leading venture capitalists expressing interest in the potential of mavoglurant in substance abuse treatment.

Closing Thoughts and Future Initiatives

The series B round, led by SPRIM Global Investments Pte Ltd., with additional investor participation, includes a $3.8 million credit facility. While preparations for the phase III cocaine use trial progress, the majority of the funds will be directed towards advancing the STP-1 ASD phase II study. Stalicla’s precision medicine model, involving biosampling observation trials, will be crucial in pre-recruiting patients for subsequent clinical trials. The capital raise aims to support this ambitious undertaking, with an estimated 40 patients needing screening to identify one eligible for the phase II trial.

Securing Intellectual Property and Commercial Protection

As part of their strategic approach, Stalicla sees the opportunity to build new intellectual property during the drug-drug interaction study conducted by NIDA for the phase III cocaine trial. While details remain undisclosed, CEO Lynn Durham emphasizes the importance of optimizing strategies to ensure commercial protection for mavoglurant for as long as possible.

Future Funding and Venture Capital Interest

To propel mavoglurant into addressing a broader spectrum of neurological indications, including substance abuse, Stalicla acknowledges the need for additional funding. Promisingly, leading venture capitalists have expressed newfound interest in mavoglurant’s potential in substance abuse treatment, signaling a shift in perception from the past.

Key Participants in the Series B Round

The first close of the series B round was led by SPRIM Global Investments Pte Ltd., showcasing the strong support from the investment community. Additionally, the funding includes a $3.8 million credit facility, contributing to the overall financial robustness for Stalicla’s endeavors.

Strategic Allocation of Funds and Focus Areas

While the phase III cocaine use trial takes shape, the majority of the $17.4 million series B funds will be dedicated to progressing the STP-1 ASD phase II study. Stalicla’s commitment to a precision medicine model, driven by biosampling observation trials, underlines the meticulous approach in patient recruitment and clinical trial dosing.

Looking Ahead: A Significant Undertaking

Stalicla recognizes the magnitude of the undertaking, estimating the need to screen 40 patients to identify one eligible for the phase II trial. This underscores the dedication to advancing innovative therapies for neurodevelopmental disorders and substance abuse, with a focus on patient-specific treatments.

Conclusion: Advancing Therapies with Precision and Purpose

Stalicla SA’s successful first close of the series B round not only signifies financial support but also highlights the commitment to advancing precision medicine in the treatment of neurodevelopmental disorders and substance abuse. With innovative approaches, collaborations with government agencies, and potential applications across various indications, Stalicla positions itself at the forefront of therapeutic development, driven by a mission to improve patient outcomes.

Note: This article is based on information available as of Friday, Jan. 19, 2024, and is subject to updates as the situation evolves.

©2024 BioWorld. Reprinted with permission from Clarivate.

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