Ora Inc website has news of a drug they did a Phs 2 Dry eye on. Drug from private Mimeotgen Pharma of Canada. They finished it in 2001, and B&L took an option on it a copule days ago, with upfront payment. Mimetogen did not give details of results but said they were statistical. I checked their Phs 2 design, which Ora Inc did. THEIR primary outcome was corneal staining..in ALL cornea. I gather there are up to four corneal subsections. RGRX chose corneal staining mesures in ONE subsection only... ANOTHER big mistake by RGRX. because in the "inferior" corneal subsection, TB 4 did not get statistical. but in the three other corneal subsections, they did see statistical, but they are not part of the trial! So it was a flop. WHY DID RGRX only have primary outcome on INFERIOR region of cornea. and not the OVERALl cornea. Chalk it up to the RGRX curse of mess ups in EVERY trial they have done. the results from mimetogen Phs 2 are NOt on clinicaltrials. They don't tell them! RGRX did, but ONLy in the INFERIOR region cornea. And Mimetogen gets the partner deal with Bausch & Lomb. Way to go Finkel, yet another mess.
That's good for us in a way. Maybe AGN will step up now. Maybe we are already in the final phase of a deal with them. Maybe, Fink will be CEO of the year.............................................or.....................
Whole thing is a Finkelstein nightmare. Allergan's stock has been sinking. Their no#2 revenue drug is RESTASIS. It will be going generic now. AGN sits on $2.25 billion of cash. they lose Restasis, it is a huge money machime for them. Why why can't AGN take a few million out of their $2.25 BILLION stash and see what ORA can design for a phase 2b and TB 4. Ora found great statitsical P values in 2 subsections....and, unlike RESTASIS...TB 4 has NO side effects. Anyone can take it. only a minority of dry eye foilks can do restasis.
This s***ks. RGRX never gets it right. Mimetogen has Ora do their phase 2. Now Mimietogen just got a deal with Bausch & lomb for Dry eye. Mimetogen had primary outcome of the WHOLE cornea, RGRX only had primary the INFERIOR cornes section. Mimetigen FLOPPED it's primary objective in oveall cornera. I quote from them:
"Total corneal staining score post-CAE for 1% MIM-D3 showed improvement relative to placebo, but statistical significance was not reached."
trechincally? if Mimetogen is held to RGRX standrads, the trial failed. Overall corneal staining didn't get statistical. HOWEVER? Mimetogen then breaks DOWN into the SUBSECTIONS, and what happens? A winner comes:
"Significant improvement was observed with 1% MIM-D3 in inferior corneal fluorescein staining post-CAE compared to placebo at Day 28 in the ITT population (p=0.0322)."
SEE? Mimetoigen FAILED in over all cornea. RGRX failed in the INFERIOR cornea. but RGRX got statistical in THREE other corneal subsections, Mimetogen in only ONE. But RGRX flopped and Mimetogen wins? They got the B&L deal.
Mimetogen drug flops in it's overall primary cornea endpoint, but scored in the inferior cornea. RGRX flopped on it's primary - but it blew doors off Mimetogen's drug in TWO other corneal areas, the CEntral and Superior. But all think Mimetogen scored and RGRX flopped. Read where RGRX scored, very impressive P values:
"Reduction from baseline in central corneal fluorescein staining compared to placebo at the 24 hour recovery period (p = 0.0075). Reduction of fluorescein staining is indicative of a reduction in ocular surface damage of the central cornea;
Reduction from baseline in exacerbation of superior corneal fluorescein staining in the chamber as compared to the placebo (p = 0.0210); and
Reduced exacerbation of ocular discomfort at day 28 during a 75-minute challenge in a controlled adverse environment compared to the placebo group (p = 0.0244). Reduction indicates that RGN-259 can slow exacerbation of ocular symptoms in patients with dry eye syndrome."