Additional Data From Phase 1b Study Of Hepatitis Drug Shows Positive Results

Biopharmaceutical company Achillion Pharmaceuticals Inc. said Tuesday that an additional preliminary data from its Phase 1b clinical trial of HCV Protease Inhibitor demonstrated positive results, with meaningful reductions in Hepatitis observed, and accompanied by continued safety and tolerability levels. Following the disclosure, the company's share were up 17.37% in the after hours trade.

Hepatitis C virus is the most common cause of viral hepatitis, an inflammation of the liver, and is currently estimated that more than 170 million people are infected with HCV worldwide.

ACH-1625 is an inhibitor of HCV NS3 protease that was discovered, and is being developed by Achillion. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures.

Now with the Phase 1b study, Achillon said the additional data revealed that both the third and fourth patient cohorts receiving treatment with ACH-1625 achieved meaningful reductions in HCV RNA after a five-day monotherapy.

Achillon said that results from its Third Dosing Cohort with 9 subjects, administered 200 mg twice daily over a 5 day period, showed a mean maximum reduction in viral load of 3.86 log10, compared with a mean rise of 0.16 log10 in the placebo group. Also, all subjects in the treatment group had a viral load decline greater than than 3.0 log10, and that there were no serious adverse events, and no clinically significant changes in vital signs, or laboratory evaluations. All adverse events in patients receiving ACH-1625 were classified as mild or moderate and were transient, with sustained viral suppression observed, the company added.

Further, the company said that the Fourth Dosing Cohort, with 8 subjects on a 600mg once daily dosage for five days, showed a mean maximum reduction in viral load of 3.81 log10 was achieved in the treatment group, compared with a mean rise of 0.24 log10 in the placebo group. Achillon stated that, all subjects in the treatment group had viral load decline greater than 3.0 log10, and that safety results were similar to those observed in previous segments of the trial. However, Achillon added, there was one non-drug-related serious adverse event, a bone fracture in a patient receiving placebo, but there were no clinically significant changes in vital signs, or laboratory evaluations. All reported adverse events in patients receiving ACH-1625 were classified as mild or moderate and were transient, with sustained viral supression observed.

Chief Executive Officer Michael Kishbauch said " It is impressive that at all dose levels ACH-1625 has shown meaningful viral load reduction and sustained viral suppression post treatment course. Importantly, we believe the results from these last two cohorts demonstrated that ACH-1625 was effective at a lower dosing level and in a once-daily dose, features that distinguish our drug and suggest it could offer improvements over other protease inhibitors currently in development.

If the results are sustained through further development, then ACH-1625 would contend as a potential best-in-class protease inhibitor, Kishbauch added.

Earlier, in Phase 1a safety studies with ACH-1625, where subjects were exposed to both single ascending dose, and multiple ascending dose, preliminary data demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, and no clinically significant changes in vital signs, and adverse events were classified as mild or moderate.