A unique model of patient-initiated entrepreneurship
The French Prader-Willi community is a tightly knit and well organised group, which has supported from the very beginning the academic research work carried out by Professor Maithé Tauber’s team from the National Reference Centre for Prader-Willi Syndrome at the Toulouse University Hospital (now the CRMR PRADORT – Rare Diseases Reference Centre for Prader-Willi Syndrome and other rare forms of obesity with eating disorders). Following favourable phase II results in neonates with PWS, OT4B was created in 2017 to support the continuation of this work, in particular through the implementation of a phase III study and the preparation of a possible drug registration in Europe and the rest of the world.
OT4B (OxyTocin for Babies) represents a unique model of innovative French enterprise, resulting from an alliance between academic research into Prader-Willi syndrome and the patient experience.
Supported since its creation by French entrepreneurs and business angels, OT4B’s goal is to make the first early treatment for Prader-Willi syndrome, available to as many people as possible.
OT4B is also actively working on the development of oxytocin as a treatment for older children, adolescents and adults.
Key dates in the oxytocin development programme for Prader-Willi syndrome
Orphan designations in Europe and the United States are obtained by Professor Maithé Tauber.
Positive results in the phase II clinical study initiated by Professor Maithé Tauber on the intranasal administration of oxytocin to neonates with Prader-Willi syndrome: normalised sucking in 88% of newborns, significant improvement of mother-infant interactions and excellent tolerance of the treatment in patients (Tauber, 2017).
On the basis of these major and very promising results, the OT4B start-up is created.
An exclusive strategic partnership is concluded between OT4B and Toulouse University Hospital. This partnership is focused on the continuation and development of academic research work in order to implement a European phase III clinical study, aiming at achieving the registration and entry to market of oxytocin as the first treatment for neonates and infants with this condition.
The operational team is strengthened with experts in development, registration and marketing of drugs for rare diseases in Europe and the United States, under the direction of François Vuillet.
In the midst of the Covid-19 health crisis, the European phase III clinical study (OTBB3) is launched, aiming at demonstrating the efficacy and confirming the safety of intranasal oxytocin administration in neonates and infants with Prader-Willi syndrome.
A network of French and international scientific and regulatory experts is put in place by OT4B, and its Development and Scientific Advisory Board is established.
The OTBB3 Follow-up study starts, a study to follow up and compare babies treated in the OTBB3 study with a cohort of untreated patients up to the age of four.
Compassionate use is established in France to make oxytocin treatment available for neonates and infants with Prader-Willi syndrome.
The DYSMOT clinical study starts, aiming at investigating the effects of oxytocin on dysphagia in children and adolescents with Prader-Willi syndrome.
Focus on... the founders
A scientific engineer and scientific & technical director of engineering companies, François has participated in numerous European research projects. François has played a key role in the Prader-Willi France association, from its creation in 1996, to its executive management in 2009 and serving on the scientific advisory board. François is a member of various governmental working groups on disability, and also participates in the discussion on health for opinion leaders. He is on the IPWSO Board of Trustees, where he represents France and shares his experience. His knowledge and role within the PWS community, as well as his understanding of the patients needs, are essential in the development of OT4B.
Jean-Hubert Gallouët, co-founder of OT4B.
An engineer and economist, Jean-Hubert has devoted his professional career to creating, managing and consulting businesses in the field of financial services and development throughout the world (in Europe, Africa and Asia). Among other ventures, in 2005 he created a microfinance network (Advans), which now comprises 10 microcredit institutions with more than 6,000 employees, 700,000 clients and a loan portfolio of €700 million. Today, through his investment holding (Galpaco), Jean-Hubert is an entrepreneur/business angel. He provides OT4B with his experience in company structuring and his expertise as a financier and fund-raiser.