UniCycive Therapeutics Inc (UNCY)

[Whalatane]

In case anyone should venture here
Whalatane
Member Level
Re: None
Monday, May 13, 2024 6:59:02 PM
Post# of 251809
UNCY pivotal trial update

“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter.

By my calculations this pivotal trial will end this weekend.
What remains is data checking / cleaning and then publishing results

Some background . High serum phosphorous is a continuing problem for most ( 85 % ) on dialysis due to kidney failure .
This is because almost all the patients currently taking the Pho binders hate them either because of taste ( chewed with meals ) or pill burden ( up to 12 pills a day )
Recently ARDX managed to get Xphazoh approved ...2 small pills swallowed not chewed ( one at breakfast , 1 at dinner ) While many Nephrologist want to try this drug there are 2 problems .
1) Diarrhea in half the patients for the first 2-3 wks
2) Cost if you are on Medicare / Medicaid . Medicare / Medicaid means patients can't use the coupons ARDX is currently handing out and their copay pay ( This is a tier 5 drug ) is roughly $1,000 a month .
None of the patients my wife's sees are willing to pay the copay as most are Medicare / Medicaid.

Now comes UNCY's OLC .
OLC is a new form of Fosrenol that they wife already prescribes if patients refuse Selevmar ( lowest priced generic )
The advantage of OLC is that its 1 small pill with each meal ...SWALLOWED ( this makes a difference re adherence ) ...not chewed or in powder form mixed with applesauce.
OLC is very effective at lowering serum Pho .
The problem is stomach upsets / nausea .
UNCY's final trial ..results due soon see above ..is all about tolerability .
Can they slowly increase the dose to gradually get serum Pho down to target and keep patients on the drug ?

My guess is that PPS will either drop to 50c or head towards $5 ...depending on results
Risk only what you can afford to lose and forget me if this fails ..:--)

Kiwi