Regulatory strategies for repurposing drugs-
While repurposing the drugs under the 505(b)(2) regulatory pathways in the United States, one needs to be very critical with the drug development strategy spanning across non-clinical, clinical and specifically regulatory strategy inputs from the US-FDA.
For example, one needs a detailed understanding of safety and efficacy of the approved molecule for its current indication as well as new changes that need to be implemented, like increasing solubility, changing dosage form, reducing the dose or dosing frequency, and improving patient compliance etc. You also need to assess how feasible it would be to run the clinical development program efficiently with minimum subjects being enrolled in the studies which will eventually impact the budget for the product development. It’s also important to consider the current players in the market and the expected business share. One of the most important things is to consider how you’re generating the intellectual property, which is not always obvious. This is a complex process and requires expertise across multiple domains e.g., CMC, clinical and non-clinical drug development. Fortunately, ISHA Therapeutics has all these experts available to us. We prefer to reach out to the FDA, discuss the complete repurposing program, gain specific insights, advise, then make a detailed analysis on what is feasible and what amount of time and money is needed to run that specific program. Once you have such a detailed analysis, the sponsor can make a go/no-go decision on the project.
One recent, example to share with you, a US based client wish to repurpose a small molecule currently used for CV indication by modifying its formulation e.g., improve solubility and better formulation characteristic etc. ISHA expert team worked hand in hand with the client, provided them critical inputs on formulation especially biopharmaceutics inputs to develop unique formulation with desired properties. ISHA team played a critical role in design of the clinical development plan which was extremely well received by the US-FDA Division of Cardiovascular Medicine and to the wonderful surprise of the clinical Agency agreed to doing only 2 studies that to bioequivalence studies with no need to run any safety studies going forward as well as large efficacy studies with reduced dose. Sponsors is taking the program actively forward. They are super delighted to work with us and unbiased, science inclined inputs we provided to their unique repurposing program.
ISHA has been extensively helping start-ups, mid-size, and even publicly listed companies to design effective, feasible clinical and regulatory development strategies for small molecules, synthetic peptides (including NCE), across all key therapeutic area e.g., CV, CNS, dermatology, infectious diseases etc.
If you are looking to repurpose your drug be it for COVID19, Dermatology, CV, CNS or a Rare disease, please reach out to us to discuss our unbiased science focused approach to drug development.
Manoj Jadhav, PhD, FCP
Founder and CEO