Mark Burnett saw functional improvement in six months, going from stage 3 to stage 1 Parkinson's. He validated this progress using the amyloid beta 42/40 blood test, which shows increased plaques in the blood as they drain from the brain, providing a medical metric for efficacy.
To create a fair evaluation, Mark Burnett deliberately maintained his sedentary lifestyle and diet. This ensured any improvements were directly attributable to his supplement, making the product viable for patients unable or unwilling to change their habits.
Instead of diversifying across diseases, Kenai is building deep expertise in Parkinson's. Its pipeline addresses different patient needs: replacing lost cells (lead program), repairing existing damaged cells (002), and targeting inherited forms (003), creating a comprehensive disease franchise.
Emerging evidence suggests Parkinson's is a gut-brain axis disorder. Digestive issues, particularly constipation, often appear years before the classic motor symptoms. Fecal transplants have been shown to provide durable improvement in both movement and gut symptoms for Parkinson's patients, supporting the gut-first hypothesis.
The effectiveness of modern daratumab-based therapies has significantly improved patient outcomes. This positive development paradoxically made previous staging systems, founded in eras with less effective treatments, unable to accurately identify the highest-risk patients, necessitating the creation of a new prognostic model for the current era.
Voyager CEO Al Sandrock suggests the 30% average efficacy of new Alzheimer's drugs isn't uniform. Instead, some patients may see a complete halt in progression while others see no benefit. He argues the next critical step is predicting these responders, which will determine whether future therapies like anti-tau agents should be added on or used as a replacement.
The former high-risk group (Stage 3b) was traditionally excluded from major clinical trials. The new staging system demonstrates that these patients have better-than-expected outcomes with modern therapy and should be included in future studies. It simultaneously identifies a new ultra-high-risk group (Stage 3c) that requires entirely different trial designs.
Biomarkers provide value beyond predicting patient response. Their core function is to answer 'why' a treatment succeeded or failed. This explanatory power informs sequential therapy decisions and provides crucial scientific insights that advance the entire medical field, not just the individual patient's case.
The long-term vision for Alt-Pep's diagnostic extends beyond symptomatic patients or those with family histories. The goal is for it to become a routine screening assay, administered annually to the general population to catch the disease at its earliest molecular stages, changing the paradigm from treatment to prevention.
For the newly defined ultra-high-risk Stage 3c patients, early death is primarily caused by severe organ dysfunction, not the underlying plasma cell malignancy. This indicates a strategic shift is needed for this population, requiring trials that focus on therapies like antifibril antibodies which directly clear amyloid deposits from organs to improve function.
The company's clinical trials go beyond standard pain scores to track improvements in function, sleep, and patient satisfaction. Demonstrating that patients can climb stairs, drive, and sleep better provides a more compelling value proposition for a faster return to normal life, resonating with patients, surgeons, and payers alike.