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FDA clears IND for SBC003 in RPRead more

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SBC003 Development Pipeline

An oral compound advancing across multiple indications: retinal degeneration first, CNS neurodegeneration next.

The mechanism: SBC003 induces neuroglobin expression via p-body modulation, a mutation-agnostic, endogenous pathway that protects neurons regardless of the upstream trigger. One molecule, multiple indications, no injections.

Development Overview

Multiple programs, one oral pill: no intravitreal injections.

SBC003IND-Enabling

Retinitis Pigmentosa

Indication: Retinitis Pigmentosa (RP)Route: Oral Administration
  • Unique neuro-rescuing effects against neuronal apoptosis
  • Strong neuroprotective effects against multiple neurotoxins
  • Strong neurite outgrowth promoting effects
  • Predicted with favourable safety and tolerability profile
  • With a good uptake by the brain and retina
  • Recovery of interdigitation zone/photoreceptor structure in the macular area

Development Stage

  1. Discovery (completed)
  2. Research Stage (completed)
  3. Preclinical Development (completed)
  4. IND-Enabling
SBC003Preclinical Development

Dry AMD

Indication: Dry Age-Related Macular Degeneration (DAMD)Route: Oral Administration
  • Prevents and repairs photoreceptor apoptosis through anti-neuronal apoptotic mechanism
  • Improves visual function by enhancing lysosomal scavenger protein aggregation
  • Reduces age-related cellular debris accumulation
  • Recovery of interdigitation zone/photoreceptor structure in the macular area

Development Stage

  1. Discovery (completed)
  2. Research Stage (completed)
  3. Preclinical Development
  4. IND-Enabling
SBC003Preclinical Development

Optic Atrophy

Indication: Primary and Secondary Optic Atrophy (POA, GOA)Route: Oral Administration
  • Following oral administration, Rhesus monkeys with spontaneous optic atrophy showed recovery in RNFL thickness
  • Improvement in both RNFL and macular structure suggests broad utility

Development Stage

  1. Discovery (completed)
  2. Research Stage (completed)
  3. Preclinical Development
  4. IND-Enabling
SBC003Preclinical Development

CNS Neurodegeneration

Indication: CNS Neurodegeneration (Alzheimer's, Parkinson's, ALS)Route: Oral Administration
  • Excellent blood-brain barrier penetrance as a low-molecular-weight, orally bioavailable compound
  • Anti-apoptotic and proteostasis mechanisms validated in retinal models translate directly to CNS proteinopathies
  • Endogenous neuroprotective pathway activation relevant across multiple CNS neurodegenerative targets defined by toxic protein aggregation
  • Strong scientific rationale for target expansion into Alzheimer's disease, Parkinson's disease, and ALS following RP clinical validation

Development Stage

  1. Discovery (completed)
  2. Research Stage (completed)
  3. Preclinical Development
  4. IND-Enabling

Market Opportunity

SBC003's lead indications span retinal degeneration and CNS neurodegeneration. The neurodegenerative therapeutics market is growing at 5.7–7.2% CAGR, driven by aging demographics and the structural shortcomings of the one-target drug paradigm.

Retinitis Pigmentosa

Market Size
Significant unmet need
Growth
12.1% CAGR
Patients
2M globally

Unmet need: 99% have no disease-modifying treatment

Dry AMD

Market Size
Significant unmet need
Growth
9.3% CAGR
Patients
200M globally

Unmet need: No approved oral treatment; EMA rejected both approved injectables

Optic Atrophy

Market Size
Significant unmet need
Growth
8.8% CAGR
Patients
~2M in US/EU/China/Japan

Unmet need: No approved neuroprotective treatment

CNS Neurodegeneration

Market Size
Significant unmet need
Growth
5.7–7.2% CAGR
Patients
32–38M Alzheimer's, 10M Parkinson's, globally

Unmet need: No approved disease-modifying therapy across all major CNS indications.

Why SBC003 Is Different

No other compound in development combines oral bioavailability, broad-spectrum neuroprotection, and retinal + CNS potential in a single molecule.

  • Oral Administration

    SBC003 is a simple, daily pill.

  • Mutation-agnostic

    Targets the universal neuronal apoptosis pathway downstream of any mutation. Applicable to 100% of RP patients vs. <1% eligible for gene therapies like Luxturna.

  • Five-protein shield

    Published evidence of protection against all five major neurotoxic proteins (amyloid-β, α-synuclein, tau, prion, and amylin) in a single peer-reviewed Aging Cell paper.

  • Validated in primates

    Significant RNFL recovery in rhesus monkeys with naturally occurring optic atrophy at oral doses of 5–50 mg/kg. Plasma concentrations of 47.6–86.4 ng/mL confirmed.

  • Rescue, not just protection

    The only oral, mutation-agnostic RP program with evidence of restoring function in already-damaged tissue: from late-stage rescue in a genetic mouse model, to RNFL recovery in primates with existing optic atrophy.

Explore the Science Behind the Pipeline

Understand the mechanism of action, preclinical data, and the peer-reviewed evidence supporting SBC003.

Our SciencePublicationsInvestor Information

SBC003 is investigational and has not been approved by any regulatory authority. This page presents scientific and development-stage information only.