ADHD
- ·23M individuals in the US
- ·20-30% of stimulant-treated children experience clinically significant nightly insomnia
Unmet needMany treatments exist, but none also improves sleep
Lexington, MA · Neurodevelopment
Strengthening Executive Function in neurodevelopmental conditions
Anaka is developing AKA1315, a first-in-class, clinical-stage therapy in parallel development for executive function impairment in ADHD, Down syndrome (DS-EF) and autism, with pipeline-in-a-product franchise potential.
~32M
individuals with ADHD, Down syndrome and autism spectrum disorder in the US
0
approved therapies designed to directly stabilize the EF network
5
drugs brought to market by our founding team
ADHD Lead ProgramDS-EF Lead ProgramIon Channel Modulation505(b)(2) PathwayFirst-in-Class Mechanism
The challenge
A significant, unaddressed need across
neurodevelopmental conditions
Executive function (EF), the brain's control system governing working memory, inhibition, cognitive control, planning, and attention, is significantly impaired in ADHD, Down syndrome, and autism. Across all three, no approved therapy is designed to directly stabilize the EF network itself.
Down syndrome executive function (DS-EF)
- ·70%+ of individuals with DS have significant EF impairment
- ·Impacts independence, learning, communication, and sleep
Unmet needNo approved treatment for EF impairment
Autism spectrum disorder
- ·8M individuals in the US
- ·Many current options cause sedation or stimulant-type effects, with limited EF benefit
Unmet needNo approved treatment for EF impairment
Current treatments fall short
All existing options (stimulants, reuptake inhibitors, α2A agonists, and psychotropics) target monoamines, not the underlying prefrontal network dysfunction believed to drive EF impairment. None is designed to directly stabilize the affected neuronal firing. None improves sleep.
Down syndrome specialists describe a successful executive-function therapy as a potential blockbuster, and say better executive function is among the very top priorities families ask for.
Sources: de Graaf et al., Genet Med 2017; Eur J Hum Genet 2022; Skotko et al. estimates; Santoro et al., Genet Med 2020; Edgin et al., Neurosci Biobehav Rev 2015; Diamond 2013; Fidler 2005, 2009; Churchill et al., Sleep Med Rev 2015.
Our approach
AKA1315: stabilizing the brain's control system
Over three decades, co-founder Mario Sanchez systematically observed that compounds stabilizing neuronal firing produced consistent improvements in executive function across ADHD, Down syndrome, and autism, while standard neurotransmitter-targeting drugs did not. This hypothesis led directly to identification of AKA1315.
The driver of EF impairment
Unstable prefrontal network activity
EF impairment reflects a pattern of unstable prefrontal cortex (PFC) network activity, characterized by:
- ·Inconsistent attention and working memory
- ·Poor cognitive control and inhibition
- ·Worsening with sleep disruption and stress
- ·Shared downstream network instability across ADHD, DS, and autism, not a single upstream cause
Our mechanism
Direct neuronal firing stabilization
AKA1315 directly stabilizes neuronal firing via dual-state ion channel modulation:
- ·Reduces pathological firing variability
- ·Restores signal-to-noise in PFC networks
- ·Supports stable prefrontal network function
- ·No mechanistic overlap with any other active Down syndrome program in development
AKA1315 is the only therapy in development with early human signal across executive function, sleep, and mood in more than one neurodevelopmental condition, and one of the lowest regulatory-risk profiles of any active program in this space.
Why AKA1315
A development plan built to de-risk a historically difficult category
Neurodevelopmental drug programs typically fail for well-understood reasons: poorly characterized mechanisms, high placebo response, and unproven formulations. AKA1315's plan is designed to retire each of those risks in sequence, before the next dollar is spent.
Known safety profile
AKA1315 combines components with decades of established clinical safety data, removing the discovery-stage toxicology risk that sinks many CNS programs.
One new variable at a time
The modified-release formulation is the single genuinely new element in the program, gated by an objective pharmacokinetic readout before advancing.
Early human signal already observed
Consistent, early signals in executive function, sleep, and mood have been observed across three distinct conditions, ahead of the controlled studies designed to confirm them.
Staged, gated development
Each phase is tied to pre-committed, objective go/no-go criteria, so capital is only deployed once the prior risk has been retired.
Programs
A single asset with
Executive Function franchise potential
AKA1315 targets the EF network layer shared across multiple neurodevelopmental conditions. ADHD and Down syndrome executive function (DS-EF) are being developed in parallel as lead indications, with autism spectrum disorder as a follow-on franchise opportunity built on the same mechanism.
AKA1315Modified-release fixed-dose combination505(b)(2) regulatory pathway
Indication
PreclinicalPre
FormulationFDC
Phase 1Ph 1
Phase 2Ph 2
Phase 3Ph 3
ApprovalAppr.
ADHD
Lead indication
Preliminary human signal*
In planning
Current stage: In planning
Down syndrome executive function (DS-EF)
Lead indication
Preliminary human signal*
In planning
Current stage: In planning
Autism spectrum disorder
Follow-on
Preliminary human signal*
Future
Next: Future
CompletedOngoingCurrent stagePlanned
* Preliminary human signal is based on investigator-initiated, open-label experience and case series with the program's component therapies; it is not controlled clinical efficacy evidence for the final AKA1315 formulation. ADHD = attention-deficit/hyperactivity disorder; DS-EF = executive-function impairment associated with Down syndrome; FDC = fixed-dose combination.
The team
Experienced team and advisors built for CNS and Down syndrome development.
Our team brings together deep neuroscience and Down syndrome expertise, more than 100 years of drug development, and 30+ years of clinical insights across ADHD, DS, and autism -- built specifically to execute in neurodevelopmental conditions.
Hampus Hillerstrom, MBA, MSc, MS
President · CEO · Co-founder
- ·Started three biotech companies
- ·Led national Down syndrome research non-profit for 9 years
- ·Former VC, investment banking, and pharma executive
- ·MBA from Harvard Business School; MSc from HST/BEP (Harvard-MIT)
Luc-Andre Granier, MD, PhD
Chief Medical Officer · Chief Development Officer · Co-founder
- ·MD/PhD neurologist and psychiatrist
- ·Started four biotechs; one exit, three ongoing
- ·Five drugs approved across career
- ·Six years at Lilly Neuroscience
Jonathan Levenson, PhD
Chief Scientific Officer
- ·19 years, incl. as CSO, in neuropsychiatry, neurodegeneration, and neuroinflammation
- ·Prior work on ion channel modulation
Caroline Roussel-Maupetit, MEng
Head of Formulation & Manufacturing
- ·30+ years in biopharma industry
- ·Expert on GLP/GMP manufacturing, formulation, and clinical batch production
Mario Sanchez, Clin. Psych.
Scientific Originator · Co-founder
- ·30+ years treating patients across EF disorders, addiction, and autism
- ·Originator of the neuronal firing stabilization hypothesis that identified AKA1315
In memory of Mario Sanchez, who passed in April 2026. His clinical insight is the foundation of this work.
Scientific & clinical advisors
Andrew Cutler, MD
Clinical Prof. of Psychiatry, SUNY Upstate; PI on 400+ CNS & ADHD clinical trials
William Mobley, MD, PhD
Distinguished Prof. & Exec. Dir., UCSD Down Syndrome Center; DS neurobiology leader
Xavier Liogier d'Ardhuy, PhD
Chief of Translational Science, Loulou Foundation; ex-Roche DS & autism clinical lead
Joe Horrigan, MD
Pediatric neuropsychiatrist; ex-Autism Speaks & GSK; CMO across multiple CNS biotechs
Get in touch
Investor & partnership
inquiries welcome
We welcome conversations with potential investors, partners, and collaborators aligned with our mission to address the significant unmet need of executive function impairment across neurodevelopmental conditions.
Lexington, MA · Greater Boston Area
Hampus Hillerstrom
President, CEO, Co-founder
Emailinfo@anakapharma.com
AddressAnaka Pharmaceuticals, Inc.
21 Seaborn Place, Lexington, MA 02420
21 Seaborn Place, Lexington, MA 02420