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LONDON, UK / ACCESSWIRE / August 11, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) ("Achillion"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=ACHN. The Company announced on August 08, 2017, that it has achieved proof-of-concept, via factor D inhibition, in assessing efficacy, safety, and pharmacokinetics of ACH-4471, Achillion's first orally-administered, small molecule factor D inhibitor for patients with paroxysmal nocturnal hemoglobinuria (PNH). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Developing ACH-4471
Phase-2 clinical trials for untreated PNH - Achillion announced the initiation of a phase-2 three-month, dose-ranging trial with ACH-4471 for patients with untreated PNH, in April 2017, with the objective of assessing the change-from-baseline in serum lactate dehydrogenase (LDH) levels, a sensitive biomarker for intravascular hemolysis, after dosing with ACH-4471. Changes in hemoglobin, PNH red blood cells, fatigue score (FACIT scale), changes in levels of complement pathway biomarkers, pharmacokinetics, and safety were assessed. Initially, patients received 100 mg or 150 mg of ACH-4471 three times daily with the ability to increase dosage during the treatment period, with 200 mg three times daily being the highest dose administered. The protocol is designed for enrollment of four to twelve patients, and after three months of treatment with ACH-4471, patients may be enrolled into the long-term extension trial.
Achillion has data for four patients with PNH, two of whom have completed the three-month trial and have entered the long-term extension trial. Interim data from these ongoing trials demonstrated that ACH-4471 achieved clinically meaningful complement inhibition and demonstrated a favorable tolerability profile with no reports of clinically meaningful increases in liver enzymes. In this emerging data set, ACH-4471 has improved LDH, hemoglobin, fatigue score, and other measures of response including PNH clone size. These interim results support the Company's global expansion plans for the PNH clinical program.
About Paroxysmal Nocturnal Hemoglobinuria (PNH): PNH is a rare, acquired, life-threatening disease characterized by the destruction of red blood cells (hemolytic anemia), blood clots (thrombosis), impaired bone marrow function, and a risk of developing leukemia.
C3 Glomerulopathy (C3G) - Achillion has an on-going agreement with Imperial College London to conduct a natural history study of C3G, a rare renal disorder which includes dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). The aim of this study, which began earlier this year, is to collect data on disease progression and will run in parallel with other C3G clinical studies.
During H2 2017, Achillion anticipates initiating patient dosing in a phase-2 open-label trial of ACH-4471 for patients with low C3 levels due to C3G or immune-complex membranoproliferative glomerulonephritis (IC-MPGN). This 14-day trial is expected to enroll approximately 10 patients.
The Company believes alternative pathway complement inhibition via factor D uniquely may be able to prevent the formation of C3 fragments, and that its compounds may have an opportunity to meaningfully benefit patients who suffer from this disease for which there are no currently approved treatments.
About C3 Glomerulopathy (C3G): C3G is a rare renal disease which is believed to be the result of over-activity of the AP. There is currently no cure available for C3G, no approved treatment to prevent disease progression and a poor prognosis for patients, of whom approximately 30%-50% require dialysis or kidney transplant 10 years after diagnosis.
Developing ACH-5228
ACH-5228 is one of Achillion's next-generation factor D inhibitors being developed for oral administration. The compound has demonstrated complete inhibition of the complement alternative pathway after repeat, twice-daily dosing in nonhuman primates over a seven-day period, but has the following preclinical characteristics:
- Potency: ACH-5228 is also specific for factor D inhibition, and had a two to three-fold greater potency than ACH-4471 in preclinical studies.
- Pharmacokinetics and Metabolism: Pharmacokinetic characteristics for ACH-5228 suggest the possibility of once- or twice-daily dosing frequency.
- Safety: Achillion has completed short-term nonclinical studies in rats and dogs in which ACH-5228 demonstrated tolerability and safety margins
Achillion anticipates initiating a first-in-human phase-1 clinical trial with ACH-5228 by year-end 2017.
Next-Generation Factor D Inhibitors for Geographic Atrophy (GA)
Achillion has selected several compounds from its factor D inhibitor platform with physicochemical properties that may be advantageous for delivery to the back of the eye for the treatment of GA, a disease with no currently approved therapies, with the goal of achieving treatment intervals of 3 months or longer. The Company anticipates selecting one or more lead compounds and delivery technologies by year-end 2017.
World-wide Collaboration with Janssen for Chronic Hepatitis C Viral Infection (HCV)
In May 2015, Achillion announced a worldwide collaboration with Janssen Pharmaceuticals, Inc. ("Janssen"), for the treatment of HCV. Janssen is currently completing OMEGA-1, a phase-2b, multicenter, randomized, open-label study to investigate the efficacy, safety, and pharmacokinetics of different treatment regimens of JNJ-4178, a once-daily combination of AL-335; odalasvir, a compound licensed from Achillion; and simeprevir, in treatment-naive and treatment-experienced subjects with HCV genotype 1, 2, 4, 5, and 6 infection, with and without cirrhosis.
In April 2017, Achillion reported that Janssen's OMEGA-1 global phase-2b clinical trial was fully enrolled with a total of 365 subjects. Results from this trial are anticipated during the second half of 2017.
Q2 2017 Financial Results
Achillion also reported financial results for the three and six months ended June 30, 2017. For Q2 2017, the Company reported a net loss of $22.5 million, or $0.16 per share, compared to a net loss of $18.5 million, or $0.14 per share, for Q2 2016. Cash, cash equivalents, marketable securities, and interest receivable were $369.9 million as of June 30, 2017.
Last Close Stock Review
On Thursday, August 10, 2017, the stock closed the trading session at $4.43, declining 7.90% from its previous closing price of $4.81. A total volume of 4.83 million shares have exchanged hands, which was higher than the 3-month average volume of 1.85 million shares. Achillion Pharma's stock price surged 14.18% in the past three months and 2.78% in the previous six months. Furthermore, since the start of the year, shares of the Company have gained 7.26%. The stock currently has a market cap of $605.68 million.
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