The Alzheimer's disease treatment landscape is rapidly shifting. Lecanemab's full approval marks a watershed moment, but the intravenous administration of these new antibody therapies presents a significant hurdle for widespread adoption. While the world focuses on the complexities and costs associated with these injectable treatments, a small company, Cognition Therapeutics (CGTX), might just be laying the groundwork for a quiet revolution.

The recent Q4 2023 earnings call for Cognition Therapeutics was, on the surface, a standard affair. The company provided updates on its ongoing clinical trials – SHINE for mild to moderate Alzheimer’s, SHIMMER for dementia with Lewy bodies, START for early-stage Alzheimer’s, and MAGNIFY for geographic atrophy secondary to dry AMD. However, beneath the routine updates, there lies a potentially game-changing detail that seems to have slipped past most analysts: the potential for CT1812 to not only be a viable standalone treatment for Alzheimer's, but also a crucial component of combination therapies, particularly with the newly approved antibody treatments.

Cognition's decision to allow patients on stable background therapy with Lecanemab to enroll in the START trial is a subtle but powerful move. It signals a confidence in CT1812's safety and efficacy profile, particularly in the context of ARIA, a major concern associated with antibody therapies. But more importantly, it points towards a future where an oral, synapse-protecting drug like CT1812 could be used in conjunction with plaque-clearing antibodies to deliver a multi-pronged attack against Alzheimer's disease.

Imagine a scenario where an Alzheimer's patient, instead of undergoing bi-weekly intravenous infusions of Lecanemab, could take a daily pill of CT1812 in conjunction with less frequent Lecanemab treatments. This combined approach could potentially offer a more convenient and potentially safer treatment regimen, while maximizing the therapeutic benefits by addressing both amyloid plaque build-up and synapse loss, the two hallmarks of the disease.

This hypothesis is further bolstered by Cognition's preliminary analysis of the first 24 patients in the SHINE study, where they saw a 3-point difference in the slowing of cognitive decline compared to placebo on the ADAS-Cog11 after just six months. This is a significant difference, even exceeding the 1.4-point difference observed with Lecanemab over 18 months. While it is critical to wait for the full SHINE results before drawing definitive conclusions, this preliminary data, combined with the START trial design, creates a compelling narrative for CT1812's potential role in combination therapies.

The financial data further reinforces this narrative. Cognition's cash runway extends through May 2025, fueled by a recent $11.5 million public offering and $67.5 million remaining in grant funds from the National Institute on Aging. This provides ample time for the company to generate data from both SHINE and START, potentially setting the stage for a pivotal Phase 3 trial evaluating CT1812 as a combination therapy with Lecanemab.

This strategic focus on combination therapy is particularly astute considering the emerging competitive landscape. While other companies scramble to develop 'me-too' antibody therapies, Cognition is quietly positioning itself as a crucial partner for these very companies. An oral drug like CT1812, with its potential for enhancing efficacy and mitigating the risks of ARIA, could become an incredibly attractive asset for pharmaceutical giants seeking to optimize their existing antibody treatments.

Of course, there are risks and uncertainties inherent in any drug development program. The full SHINE results could be less impressive than the preliminary data suggests, and the START trial, which aims to enroll a large cohort of 540 patients, could face enrollment challenges. However, the potential for a convenient, oral treatment option for Alzheimer's, particularly in combination with existing antibody therapies, is too significant to ignore.

Cognition Therapeutics, with its novel approach to targeting amyloid beta oligomers and a strategic focus on combination therapies, is a company worth watching. If their upcoming clinical data lives up to its potential, CT1812 might just be the oral revolution the Alzheimer's market desperately needs.

R&D Spending Trend

The following chart shows Cognition's Research and Development spending over the past three years, reflecting their commitment to advancing CT1812.

"CT1812, an oral drug, shows promising potential as a standalone or combination therapy for Alzheimer's disease. Cognition Therapeutics is strategically positioning itself as a partner for companies developing antibody therapies. The company is well-funded, with a cash runway extending through May 2025. Upcoming clinical data readouts in 2024 could be pivotal for CT1812's development and market potential."

"The sigma-2 receptor, CT1812's target, was initially discovered in the 1970s, but its role in neurodegenerative diseases has only recently come to light, opening up exciting new avenues for drug development."