Biotech Values

[RockRat]

RE: ITEK

>>Last I remember trabodenoson + latanaprost failed to achieve the level of IOP lowering as Timolol (a beta-blocker) + latanaprost in a p2 study<<

I can find no numbers from this study except for an additive effect for the combo. Timolol is no better than PGAs on efficacy. AAO's Glaucoma Panel puts the IOP reductions in the range of 20%-25% and 25%-33% (6-8 mmHg) respectively. The company says addition of trabodenoson to latanoprost resulted in a further reduction of 5.5 mmHG in the study population, which was poor responders to PGAs.

A study of latanaprost/timolol combo (Xalacom) in a similar population only got 2.7 mmHg.

Xalacom study

But in this, later, blinded study, that combo did better.

blinded latanoprost/timolol study

Though approved in other some countries, the FDA has issued a couple of approvable letters a decade ago, and the combos remain unapproved here. The study authors all say those combos are safe and well-tolerated.

For some reason, the FDA hasn't agreed on the fixed combo efficacy.

Revisiting combination drugs for glaucoma

Even though Dr. Higginbotham was still trying this over ten years later, no commercial result.

Anyhow, while it's possible that latanoprost and timolol beat latanoprost and trabodenoson, it looks like it would be close to me.

Can you provide a link that shows the failure?

That the company doesn't seem to provide hard data does make one wonder. I have some faith in management, predominantly from Sepracor, which did OK. The study was completed sufficiently long ago for publication to have taken place somewhere, but I can't find it for the life of me. Company admits it's not a first line drug.

I should note the latanoprost and timolol combo also reduces hyperemia, one trabodenoson's claims to fame. The two are generic, but so far as I can tell, aren't prescribed as a combo off label. Compliance has been shown to be an issue if you can't deliver an actual blend of the two drugs.

I have a small position in ITEK, now at breakeven. I do wonder if the FDA will approve a beta-blocker/PGA combo, finally, but I can find nothing to suggest that is in play. Not sure if a trabodenoson/PGA combo would face the same regulatory risk.

And insurers would have to get on board.

Plenty of risks, but I didn't think the failure you mention was one of them. Curious if you can find the data to back up that contention. I would probably bail the position if you could.

Regards, RockRat