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Are antagomirs the best compounds that could be practical for treating multiple human diseases? Could companies like Alnylam (ALNY) initi

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ate first clinical trials using antagomirs relatively soon? I believe the answers to both questions are yes.

The paper published a coupl

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

of days ago by the scientists from Alnylam, the Rockefeller, and NY University (see the abstract below) provides perhaps the most convin

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ing evidence from animal studies that RNAi-related approaches could be practical for treating multiple human diseases. While the experime

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ts were done in mice, there is little doubt that the approach could be tailored to humans. Two points in the paper are critical. First, t

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ere is very specific and potent inhibition of the targeted miRNAs. Second, the application of the “drug”, antagomir, delivered via simple

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

intravenous injection, affected most tissues in the animals. Both the amounts of antagomirs introduced and the delivery method (intraveno

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s injection) are likely feasible for humans.

When could the first clinical trials be initiated in humans? Now that there is an antagomir

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

tool to knock down miRNAs, what we need are target miRNAs that could be involved in human diseases. While there are many protein coding g

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nes known or suspected to be involved in various diseases, almost nothing is known about miRNAs in this respect. But, this is going to ch

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nge were quickly via research in the academia and the industry. There are already examples of miRNAs implicated in cancer. For instance,

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

iRNA let-7 is a suspected tumor suppressor. Knocking out a tumor suppressor won’t stop cancer. So other miRNAs that are required for canc

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

r survival and not cancer suppression are needed. I am sure the research to locate such miRNAs is in high gear already. We will probably

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ee the first clinical trials using antigomirs in the 1-2 years.

Simple calculation shows that the antagomir dose used on mice (80 mg/kg)

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

translates to about 6 g/injection for an adult person. Now, with 6 g/dose what could be the price tag to synthesize compounds like antago

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

irs? Antagomir synthesis is essentially the same as synthesis of modified RNA oligonucleotides. My estimates are that antagomirs could co

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

t around 1000$/g or 6,000$/dose for humans. So, even if the drug’s effect could last around a month like in mice, the medicine is still p

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

icey. Of course, the price should come down as the scale of the synthesis is increased but I still see the expensive price of synthesis a

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

a potential problem for commercialization of antagomir-base therapies.

Reference:
Nature. 2005 Oct 30; [Epub ahead of print]

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ilencing of microRNAs in vivo with 'antagomirs'.
Krutzfeldt J, Rajewsky N, Braich R, Rajeev KG, Tuschl T, Manoharan M,
Stoffel M

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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