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A first in category prescription regimen for ADHD combining stimulants with intelligent dosing and digital capabilities

Periodic Reporting for period 1 - OnDosis01 (A first in category prescription regimen for ADHD combining stimulants with intelligent dosing and digital capabilities)

Reporting period: 2019-04-01 to 2019-09-30

Attention-deficit hyperactivity disorder is the most under-diagnosed, yet most treatable within the spectrum of psychiatric disorders.
Worldwide prevalence of ADHD has been estimated to be around 2.2% in children and around 2.8% in adults. Recent studies point out how these condition is associated with increased criminality and mortality rates among youngsters and adults. Stimulants are highly effective in treating ADHD; however, they raise significant concerns about adverse effects and potential for abuse.
To address the needs of ADHD patients and their poor compliance to treatment schemes, OnDosis is developing an innovative product, which will be prescribed as a drug/device combination regimen, combining active compounds and a patented technology platform that enables dose control and compliance monitoring.
OnDosis 01 has been developed with a modular approach, and it is based on a core technology platform that tailors the therapy to specific disease or user requirements.
OnDosis 01 has the potential to become a first-in-category device with “full features offering”, meaning it effectively addresses the major unmet needs in ADHD treatment: flexible and tailored dosing, improved adherence, abuse/misuse control, progress monitoring whilst enhancing patient acceptability. In contrast to today’s alternatives, it is delivered as prescription medicine with all features integrated in one unit.
The feasibility assessment included three major sections: 1) Clinical and technical feasibility evaluation, 2) Market feasibility assessment, and 3) Business Strategy development and implementation.
Based on this structure, we progressed from the primary market data collection and analysis, through the synthesis of the results, to finalising the financial and licensing targets, aligning our processes and business development plan with the overall strategy of the company.

The key methods used in this project included: desk research, analysis of the primary and secondary market data, interviews with professionals in the field (medical and commercial), attendance at medical and research conferences.
The collected data have provided us with valuable insights into the current market trends and opportunities for improved therapeutic regimens in ADHD, recent clinical development results, and activities undertaken by competitors.
Two groups of stimulants have been approved by the FDA and EMA for the ADHD treatment: methylphenidates (MPH) and amphetamines (AMPH).
These agents usually come in the following preparations: tablets, chewable tablets, capsules, and oral solution. The MPH formulations also include transdermal patch for application to the skin. However, none of these formulations allow for fine titration tailored on the user's need. Importantly, none of the existing products offer a solution that would combine active substance and digital device into one integrated medical device to address all major unmet needs in ADHD at once, including a drug formulation which allows for fine dosing specifically tailored on the user's needs.
OnDosis’ vision is to address the growing needs of ADHD patients and become the leader within ADHD therapy’s portfolio.
However, potential partners and investors have already expressed their interest in our device, as it offers a unique opportunity to address unmet needs in a range of diseases, such as pain medication, epilepsy and anti-rejection therapies.
We anticipate entering into co-development agreements with other pharmaceutical companies, with which we have ongoing consultations.