RCS - Cambridge Cognition - Cambridge Cognition submits FDA Letter of Intent

Cambridge Cognition HoldingsAnnouncement

18/02/2025 07:15

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RNS Number : 4165X  Cambridge Cognition Holdings PLC  18 February 2025

18 February 2025

Cambridge Cognition Holdings plc

("Cambridge Cognition", the "Company" or the "Group")

Cambridge Cognition submits FDA Letter of Intent for Cognitive Impairment
Assessments in Schizophrenia

 

Cambridge Cognition (AIM: COG), the brain health software group specialising
in digital products to advance clinical research and patient treatment, has
submitted a Letter of Intent to the U.S. Food and Drug Administration (FDA)
under the Drug Development Tool pathway, outlining its plan to develop and
validate an objective and reliable measure of cognitive impairment associated
with schizophrenia (CIAS).

The FDA has indicated that CIAS improvement could serve as a co-primary
outcome in schizophrenia clinical trials, alongside functional improvement(1).
This development aligns with the growing recognition of cognitive symptoms as
a crucial treatment target in schizophrenia care.

CIAS affects functions such as memory, attention, and problem-solving in
people with schizophrenia. It appears early in the illness, even before
medication starts. The impairment is typically more severe than cognitive
issues seen in other mental health conditions and impacts daily functioning;
making it harder for patients to work, maintain relationships, and live
independently. Research shows that CIAS accounts for up to 60% of functional
challenges faced by patients(2). Unlike other schizophrenia symptoms, CIAS
tends to persist regardless of whether other symptoms are well-controlled and
there is no approved treatment which targets this important symptom.

The Letter of Intent outlines Cambridge Cognition's proposed approach to
digital cognitive assessment for use in clinical trials in CIAS, making use of
its touch screen computerised cognitive tasks and providing scalable
assessments of the core cognitive domains affected in schizophrenia, reducing
some of the burden associated with lengthy and potentially less accurate
pencil and paper cognitive tests. The approach builds on recent positive
exploratory results using several of these assessments in a Phase III clinical
trial of patients with schizophrenia(3).

Rob Baker, Joint Managing Director and Chief Operating Officer, commented:

"This Letter of Intent submission to the FDA marks a pivotal moment in our
strategy to address the critical need for improved cognitive assessment in
schizophrenia. If approved, this holds the potential to streamline clinical
trials and accelerate the development of targeted treatments. Our approach
offers unique advantages in terms of sensitivity, reliability and ease of use
compared to traditional cognitive assessment methods. While we are still in
the early stages of this regulatory process, we are confident that our
extensive scientific foundation and clinical evidence base position us well
for constructive discussions with the FDA."

The Company will provide further updates as appropriate.

1.     Keefe RS, Haig GM, Marder SR, Harvey PD, Dunayevich E, Medalia A,
Davidson M, Lombardo I,
Bowie CR, Buchanan RW, Bugarski-Kirola D. Report on ISCTM consensus meeting on
clinical
assessment of response to treatment of cognitive impairment in schizophrenia.
Schizophrenia bulletin.
2016 Jan 1;42(1):19-33

2.     Barnett JH, Robbins TW, Leeson VC, Sahakian BJ, Joyce EM, Blackwell
AD. Assessing cognitive
function in clinical trials of schizophrenia. Neuroscience & Biobehavioral
Reviews. 2010 Jul
1;34(8):1161-77

3.     Horan, William P., et al. "The Impact of Xanomeline and Trospium
Chloride on Cognitive Impairment in Acute Schizophrenia: Replication in Pooled
Data From Two Phase 3 Trials." American Journal of Psychiatry (2024).

 

 

 

Enquiries:

 

 Cambridge Cognition Holdings plc                                 Tel: 012 2381 0700

 Rob Baker, Chief Operating Officer and Joint Managing Director

 Panmure Liberum   Limited (NOMAD and Joint Broker)               Tel: 020 7886 2968

 Freddy Crossley / Will Goode / Mark Rogers                       (Corporate Finance)

 Rupert Dearden                                                   (Corporate Broking)

 Dowgate Capital Limited (Joint Broker)                           Tel: 020 3903 7715

 David Poutney / James Serjeant

 Hudson Sandler (Financial PR and IR)                             Tel: 020 7796 4133

 Dan de Belder / Hattie Dreyfus / Harry Griffiths                 cog@hudsonsandler.com (mailto:cog@hudsonsandler.com)

 

Notes to Editors

About Cambridge Cognition

Cambridge Cognition is a brain health software group specializing in digital
health products that advance brain health research and treatment.

The company offers four core products: CANTAB® assessments-providing
scientifically validated, highly sensitive, precise, and objective measures of
cognitive function correlated to neural networks; a flexible and proven eCOA
platform with an extensive library of instruments, enabling efficient study
setup and scalable data capture; rater training services that standardise
assessment delivery and scoring across clinical trials and quality assurance
tools that ensure data integrity by automatically detecting deviations in
administration and scoring, saving time and money. These products collectively
improve clinical trial outcomes, enable early patient identification, and
enhance global efficiency in healthcare and pharmaceuticals.

 

For further information, visit: www.cambridgecognition.com
(https://eur01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.cambridgecognition.com%2F&data=05%7C02%7Chgriffiths%40hudsonsandler.com%7Cc696c6a3150d40f91a9508dcfdd13b58%7Ca33bdb157e25438ab1fd5c523a8866f9%7C0%7C0%7C638664322305026349%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=vQVOIVxNQ8WYYOufDnSVKUH0oa7PLvXjnP0VT%2FzCfJc%3D&reserved=0)

 

 

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