Click Therapeutics is positioning itself at the forefront of a potential revolution in digital therapeutics, driven by the anticipated finalization of the FDA's Prescription Drug Use Related Software (PDURS) guidance. According to Randall Stanicky, CFO of Click Therapeutics, this guidance could be a "game changer," creating a pathway for combining digital drugs with traditional pharmaceuticals to enhance treatment outcomes.
Hybrid Model and Data-Driven Approach
Unlike many digital therapeutic companies that have struggled, Click Therapeutics has adopted a hybrid model, blending a tech platform with a traditional medical office and commercial pharma approach. This strategy involves partnerships with major pharma companies while also developing internal assets for FDA approval. Stanicky emphasized the company's commitment to data-driven outcomes, stating, "We have a view internally that if you can't create drug-like outcomes that, for example, if it was a pill, would pharma launch it, then if you can't do that, then you don't have a drug."
Migraine Study and Therapeutic Expansion
Click Therapeutics recently announced positive results from a pivotal study of its migraine drug, which aims to reduce monthly migraine days. The company uses traditional validated drug scales, such as the MADRS scale for major depressive disorder, to ensure comparability with existing treatments. Stanicky noted that the goal is for their digital drugs to be "as good or better than the physical drug," with the added benefit of a superior safety profile. The company envisions expanding its digital drug development to various therapeutic areas, including oncology, to address unmet needs and improve patient outcomes.
PDURS Guidance and Market Access
The PDURS guidance is expected to allow digital drugs, when combined with traditional drugs in a randomized controlled trial demonstrating clinical benefit, to have that data included in the drug label. This could significantly expedite market access by allowing digital therapeutics to move directly into existing payer coverage, bypassing the challenges of standalone digital reimbursement. Stanicky believes that the PDURS guidance will revitalize the digital therapeutics industry by emphasizing the need for clinical rigor and separating clinically validated software from wellness products.
Future of Digital Therapeutics
Stanicky predicts the formation of an entire industry around PDURS, with Click Therapeutics aiming to be a leader in this space. He envisions a future where digital drugs are combined with traditional medications to address comorbidities and improve patient care. The company's AI-driven platform allows for continuous improvement of its drugs, potentially leading to better patient engagement and efficacy over time. This approach, combined with the rigorous clinical validation, positions Click Therapeutics to capitalize on the evolving landscape of digital therapeutics.
