Accelerating Access to Safe and Affordable Treatment

Summary

In 2025, BKAMhealth committed to scale its patented LADR4 technology for drug repurposing to rapidly advance the use of therapies for existing generic treatments for cancer and diabetes. By 2027, BKAMhealth will advance two new therapies to improve availability and affordability of safe and effective treatments for two of the four disease groups that account for 80% of premature deaths from non-communicable disease worldwide. BKAMhealth will repurpose and advance a first-of-its-kind oral Taxol®, improving ease of use, availability, and cost of one of the most widely used cancer treatments. It will also advance a new form of topical treatment for diabetic peripheral neuropathy to minimize the side effects that impact patient adherence. Backed by significant experience in all facets of drug development including manufacturing, regulatory, patient-driven research, and clinical trial execution, BKAMhealth is well positioned to successfully execute on this effort.

Approach

BKAMhealth commits to the rapid advancement of two new therapies for existing generic drugs by 2027, through its patented LADR4 technology for drug repurposing, to improve availability and affordability of safe and effective treatments for high-burden diseases. LADR4 enables the development of novel, patent-protected treatments for a range of indications – with the potential for FDA approval at a fraction of the time, cost, and risk associated with traditional drug development. This addresses challenges of economic viability that have limited drug repurposing and its potential to increase availability of effective treatments.

BKAMhealth will advance oral Taxol®, transforming an intravenous therapy for solid tumors that is effective but can be costly and challenging for many to access (Humphry, 2023) , into a capsule-form that could make it more affordable, available, and easier to take. Solid tumors account for 90% (Cooper, 2000) of the estimated 20million cancer cases diagnosed annually (IARC, 2022) . BKAMhealth will also advance a topical capsaicin for diabetic peripheral neuropathy, which afflicts up to 50% (Nature Reviews Neurology, 2025) of the more than 500million people (IDF, 2025) affected by diabetes. Cancer and diabetes are two of the four disease groups that account for 80% of premature deaths from non-communicable disease (WHO) .

BKAMhealth is a joint venture of Aayam Therapeutics and Brickell Key Asset Management (BKAM) . Aayam and predecessor companies led by BKAMhealth co-founder, Sundeep Dugar, MD, have developed LADR4, which has already helped successfully advance six drugs in collaboration with US biotech companies, validating LADR4’s regulatory, financial, and exclusivity propositions. Licensees have raised over $200million for new indications for these LADR4-based therapeutics, which cover unmet indications such as acute kidney injury, peripheral arterial hypertension, and atrial fibrillation. BKAM is a U.S. SEC-registered investment advisor with over a decade of experience underwriting and raising capital for complex, IP-driven investments.

LADR4-based new methods of delivery of approved therapeutics have the potential to make them easier to use and more affordable, leading to better access to treatment.

Action Plan

Timeline for Oral Taxol and Topical Capsaicin (DPN Indication) run in parallel through first in human clinical studies (lead Oral Taxol fully through POC on allocated capital and Topical Capsaicin through FDA review) :

Starting Point: Existing approved Taxol and known compound of Capsaicin

Prior Work: Development of LADR4 platform and initial testing of Taxol and Capsaicin.

Q1-Q3 (Year 1) : KEY MILESTONE – Preparation to file for an INTERACT/PRE-IND meeting with the USFDA.

Q4-Q5 (Year 1-2) : Incorporate suggestions and responses from the USFDA into the IND package.

Q6 (Year 2) : File formal IND for a proof-of-concept clinical study in identified patient population(s) .

Q7-Q9 (Year 2-3) : Complete proof-of-concept clinical study in identified patient population(s) .

Background

There are over 10,000 diseases affecting millions of people globally that do not have any approved treatments (Global Genes, 2023) . Over 400 million people globally—and more than 30 million in the U.S.—live with these diseases (EURORDIS, 2020; NIH, 2023) with no respite in sight.

The current drug development model requires $1-2B and 10-15 years to develop a single new FDA-approved drug with a failure rate of >90% (Nature, Sci Rep, 2019) . There is not enough time nor funds for this to be the solution. Further, for approved drugs, the high price impacts affordability and access. In the US an estimated 9% owe over $250,000 due to health costs and nearly 100 million Americans owe a total of $220 billion in medical debt. (Consumer Financial Protection Board) .

Repurposing known drugs for new indications has long been positioned as a solution, but it’s been limited due to challenges around costs and economic viability that bottleneck investment (Breckenridge A, Jacob R., 2019) . Addressing these challenges can unlock the number and availability of affordable treatment options for known diseases.

Progress Update

Partnership Opportunities

BKAMhealth is seeking funding of $8M USD to advance the two identified therapeutics and complete the first-in-humans proof of concept clinical studies. Due to the existing approval and known safety of Taxol and Capsaicin, it is expected that the work to submit an investigational new drug submission will allow the clinical trial to bypass Phase 1 and move straight to Phase 2, saving significant development years and cost.

BKAMhealth is also looking for partnership opportunities with other organizations and disease foundations that can be a value add to its efforts to bring these and other therapeutics to patients worldwide that are affordable and accessible. Such partnerships will help in clinical recruitment and subsequent access to therapies for patients globally. With continuous exchange of clinical data through patient groups this will also help better align clinical practices across the globe,BKAMHealth looks forward to partnering with CGI affiliated organizations – fellow commitment-makers, foundations / charities, pharmaceutical groups and impact investors, and particularly with AI companies that have the tools to identify generic drugs for new indications. These alliances will help transform the repurposing of therapeutics for new indications for the benefit of patients. BKAMHealth and its experienced drug development team will engage with others in the CGI community to help advance their plans. BKAMHealth also has access to a global network of clinicians, contract development and manufacturing organizations, regulatory support and clinical research organizations that it can offer to partnering organizations. In essence BKAMHealth can provide the comprehensive support needed for drug development (including structuring and capital raise) to partnering organizations as its internal group are veterans of the US pharma industry.