Grigg Ingeham and Click Therapeutics collaborated in the development and commercialization of CT-155.

The FDA has rejected an application by Mallinckrodt Terlipressin to treat rare, in-patient renal failure.
the drug had previously achieved its main objectives in Phase 3 and had won the support of the Advisory Committee.
is a selective angiopressin-like product for V1 subjects, originally developed by Orphan Therapeutics and attempted to introduce it into the U.S. market.
the drug began being reviewed by the FDA more than a decade ago, even though the original Phase 3 clinical trial did not reach its main end point.
results were obvious, and the FDA rejected Orphan.
, Ikaria acquired the market rights for Terripressin in North America from Orphan.
to Mallinckrodt's $2.3 billion acquisition of Ikaria in 2015, and the North American market rights of Tligatin eventually fell into Mallinckrodt's hands.
until last year, the drug successfully conducted Phase 3 clinical trials in 300 patients with hepatitis 1 and kidney syndrome (HRS-1).
results showed that 29 percent of patients who received terripressin experienced HRS reversal (serum creatinate levels dropped from more than 2.25 mg / dL to 1.5 mg / dL on the 14th day or after discharge), compared with 16 percent of placebo patients, and the study reached its main endpoint.
when the FDA released its briefing papers ahead of its advisory board meeting in July, it had unexpected trouble.
the FDA asked the committee to consider whether the effects of terripressin on serum creatinine levels could affect the outcome of clinical treatment.
, the committee voted 8 to 7 in favour of Terrigamin's application, but apparently failed to allay all the FDA's concerns.
in its full response letter, Mallinckrodt said the FDA has questions about whether alternative endpoints used in Phase 3 clinical trials translate into meaningful clinical benefits that can offset risks, including sepsis, and the FDA believes more information is needed to support the benefits of Terrigatin in patients with HRS-1.
Chief Scientific Officer Steven Romano said he could not agree with the FDA's decision and would seek all possible ways to bring the drug to the U.S. market.
, other companies have tried to achieve this goal.
Mallinckrodt's share price has fallen more than 65 per cent this year due to a series of issues, including discussions with "financial creditors and litigation claimants", leading the company to abandon a question-and-answer session on a conference call on last quarter's results.
is understood to be on track to reach $300m a year in sales, which will ease Mallinckrodt's current business difficulties.
source: FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts Original title: Insufficient clinical benefit/risk comparison data, Mallinckrodt kidney failure drug rejected by FDA approval.