A New Generation of Oral Protein Therapies for Rare Diseases
LactoThera is developing a proprietary platform based on engineered safe bacteria designed to produce and deliver therapeutic proteins. Starting with CDKL5 Deficiency Disorder (CDD), we are validating a modular approach with the potential to address multiple rare diseases caused by protein deficiency.
3
THERAPEUTIC PROGRAMS
€700K
RAISED
1
EUROPEAN PATENT
ABOUT US
Most rare diseases still lack an effective therapy
More than 7,000 rare diseases affect millions of people worldwide, yet the vast majority still have no treatment capable of addressing their underlying cause. Many of these disorders result from the absence or dysfunction of a protein essential for normal biological function.
Advances in synthetic biology and microbial engineering are creating new opportunities to develop protein replacement therapies that are more accessible, scalable, and potentially applicable across a broad range of rare diseases.
We engineer Lactococcus lactis, a safe bacterium widely used in the food industry, into a living biotherapeutic capable of producing therapeutic proteins directly in the gastrointestinal tract.

PIPELINE
Development Pipeline
The LactoThera platform has reached TRL4 through preclinical proof-of-concept validation using model therapeutic proteins. Individual therapeutic programs are currently at different stages of development.
|
PROGRAM |
INDICATION |
APPROACH |
STAGE |
STRATEGIC ROLE |
|---|---|---|---|---|
|
LT-CDKL5 |
CDKL5 Deficiency Disorder (CDD) |
Oral microbial protein replacement therapy |
Lead therapeutic program for clinical validation of the LactoThera platform |
|
|
LT-ALDOB |
Hereditary Fructose Intolerance (ALDOB deficiency) |
Oral microbial enzyme replacement therapy |
Expansion into rare metabolic disorders |
|
|
LT-HO1 |
HMOX1 Deficiency and applications in inflammatory bowel diseases |
Oral microbial delivery of HO-1 |
Expansion toward immunomodulatory and anti-inflammatory applications |
|
|
Additional Targets |
Rare protein deficiency disorders |
Modular protein replacement platform |
Expansion of the platform to additional therapeutic proteins |
TECHNOLOGY
The LactoThera Platform
The LactoThera platform enables the design and development of engineered bacteria capable of producing and delivering therapeutic proteins.
Bacterial Engineering
Engineering food-grade bacteria to produce and secrete selected therapeutic proteins.
Oral Administration
An orally administered therapy designed to reduce the need for frequent injections and improve treatment convenience for patients.
In Vivo Production
Engineered bacteria act as living microfactories, producing and releasing therapeutic proteins directly within the gastrointestinal tract.
Systemic Delivery
The platform is designed to enable local protein release and systemic distribution, with the goal of reaching target tissues and restoring impaired biological function.
Validated Safety
We use GRAS (Generally Recognized As Safe) bacterial strains that have been extensively used in the food industry and possess a well-established safety profile.
Modular Platform
A versatile platform designed to be adapted to multiple therapeutic proteins and a wide range of rare protein deficiency disorders.
Proprietary IP
Technology protected by patent application 24175034.8 filed by the University of Bologna and exclusively licensed to LactoThera for therapeutic applications.
TEAM
Founding Team
Scientists, clinicians, and entrepreneurs committed to developing a new generation of protein therapies based on engineered bacteria.

Prof. Pietro Cortelli
Neurologist specializing in rare neurological and neurodegenerative disorders. He supports LactoThera’s clinical strategy and institutional development.

Prof. Elisabetta Ciani
(University of Bologna)
Scientific lead of the LactoThera program. For more than twenty years, she has investigated the molecular mechanisms underlying rare neurogenetic disorders and developed innovative therapeutic strategies for CDKL5 Deficiency Disorder.

Dr. Shiva Loccisano
Experienced in the management and development of innovative ventures, he supports the company’s strategic growth and business development.

Prof. Stefania Trazzi (University of Bologna)
Expert in the development and preclinical validation of innovative therapies for rare neurological disorders. She coordinates preclinical development and experimental validation of the LactoThera platform.

Dr. Antonino Caridi
Leads business development, fundraising, and relationships with patient organizations, investors, and stakeholders within the international CDKL5 community.

Prof. Maurizio Giustetto (University of Turin)
Expert in neural circuitry, synaptic plasticity, and preclinical biomarkers for neurological and neurodevelopmental disorders.

Dr. Giorgio Medici (University of Bologna)
Biotechnologist specialized in microbial genetic engineering and the development of bacterial strains for therapeutic applications. He leads the design and optimization of the microbial platform.

Prof. Aleš Berlec (Jožef Stefan Institute)
One of Europe’s leading experts in engineered bacteria for therapeutic applications, biosafety, and regulatory aspects of genetically modified microbial products.
PARTNERS & INVESTORS
Supported by Scientific, Industrial, and Institutional Partners
LactoThera was founded as a spin-off of the University of Bologna and is growing through collaborations with scientific, institutional, and industrial partners committed to advancing innovative therapies for rare diseases.




CONTACT
Let’s Transform the Future of Rare Disease Treatment Together
We welcome industrial partnerships, academic collaborations, and investment opportunities. We’d love to discuss how we can work together.
info@lactothera.com
HEADQUARTERS
Viale Fanin 48 – 40127 Bologna, Italy
BUSINESS DEVELOPMENT & PARTNERSHIPS
(To be added)

