Sept 30 (Reuters) - Crystalys Therapeutics said on
Tuesday it has emerged from stealth mode with a funding round of
$205 million to help finance global late-stage trials of its
lead drug as a treatment for gout.
The Series A financing round was co-led by Novo Holdings,
the controlling shareholder of obesity drugmaker Novo Nordisk
, SR One and Catalys Pacific, and had participation
from other investors.
The company, which had a pre-money valuation of $75 million,
had closed an initial investment in June, and had been working
with three to four additional investors for a second capital
raise, CEO James Mackay told Reuters.
Crystalys is accelerating two late-stage trials of
dotinurad, a once-daily oral drug being evaluated in the U.S.
and Europe as a second-line treatment for gout in patients
unresponsive to first-line therapies.
"There really is no available second-line treatment for
these patients," said Mackay adding that while Amgen's ( AMGN )
intravenous drug Krystexxa is successful as a third-line
treatment, the high price limits it to a small portion of
patients.
Gout is a type of inflammatory arthritis, which is caused by
buildup of uric acid in the body and leads to pain and swelling
in the joints.
Dotinurad belongs to a class of drugs which block the urate
transporter 1 (URAT1) in the kidneys, helping increase the
excretion of uric acid and lowering the blood levels of the
substance.
"Normally, you have to conduct replicate clinical trials,
but because of the extensive data that existed, the FDA agreed
that we could do two clinical trials, but two different
designs," Mackay said.
One trial is focused on reducing gout flares, while the
other aims to resolve tophi which are large uric acid crystal
deposits.
The San Diego-based company gained access to the drug from
Urica Therapeutics, a unit of Fortress Biotech ( FBIO ) which
originally licensed the drug from Japan-based Fuji Yakuhin.
Fuji Yakuhin out-licensed the drug in China and other Asian
countries to Eisai ( ESALF ). It is approved in China under the
brand name Urece.