Re: Size of phase-3 Squalamine trials:
>> I'm thinking that appropriately-sized trials [for Squalamine in AMD] would be similar to ones for diabetes. So, IMHO, you are probably looking for patients in the thousands (3-5?) <<
I strongly disagree.
Drugs for diabetes are given chronically on a regular basis (in many patients for life). Moreover, a diabetes therapy must be biologically active whenever a patient eats; hence, from a practical standpoint, a diabetes drug must produce no serious side effects which can’t be controlled by other meds.
In contrast, Squalamine has a systemic half-life of only four hours, and it needs to be administered only a limited number of times during a course of therapy. So the difference between Squalamine and diabetes drugs is as great as the difference between night and day.
Where I might agree with you about the need for super-large trials with thousands of patients is in the testing of Squalamine as a long-term maintenance therapy. However, the potential benefit of Squalamine in maintenance therapy will probably not be broached until the drug is already on the market as an acute treatment. Regards, Dew
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