The ACH-3422 POC trial is being run in New Zealand by Professor Ed Gane who also ran the trials for Gilead and Idenix. This should give everyone (including the potential bidders) a lot of confidence in the results (due this fall).
The trial protocol is at the ANZ CTR website –
“Active treatment is ACH 3422 or placebo taken at the following dosages and frequencies:
In healthy volunteers:
Group 1A: single dose of 50mg FED
Group 1B: single dose of 50mg FASTED
Group 2A: single dose of 150mg FED
Group 2B: single dose of 150mg FASTED
Group 3: single dose of 300mg
Group 4: single dose of 500mg
Group 5: 50mg, once daily for 14 days
Group 6: up to 150mg, once daily for 14 days
Group 7: up to 300mg, once daily for 14 days
Group 8: up to 500mg, once daily for 14 days.
In Hepatitis C patients:
Group 9: 50mg, once daily for 7 days
Group 10: up to 150mg, once daily for 7 days
Group 11: up to 300mg, once daily for 7 days
Group 12 : up to 500mg, once daily for 7 days
Groups 3-12 will be either fed or fasted, depending on the results from Groups 1 and 2.
ACH 3422 or placebo will be adminstered orally for all participants in all parts of the trial. All treatments will be administered in the clinic to ensure compliance.
Safety and tolerability will be assessed via adverse events, laboratory tests, ECGs, vital signs and physical examinations. PK analysis will be assessed via blood samples.
The development of drug resistant variants, and assess changes in HCV genotype and phenotype in HCV-infected subjects who receive ACH 3422 will be assessed via virology testing of blood samples.”
After the dosing and lab tests on each healthy or HCV infected cohort is completed, the results are turned over to the company for analysis and recommendations. So the company already knows the effectiveness of 3422 as a function of the dose and can project the results to higher doses. It is possible that information on the results may have leaked out to certain individuals and entities with access … such things have happened in the past. The strength the stock price is showing here suggests that these parties could be accumulating. In any case, one the 3422 results are out, it’ll be a wild ride upwards …
At the last PR of August 7, Achillion noted that the 150 mg dosing of healthy volunteers had been completed. By my estimate, they have as of now completed the 300 mg and 500 mg dosing of healthy volunteers, and the 150 mg and 300 mg dosing of HCV patients … the 500 mg dosing of HCV patients may be underway IMO … if so the results should be out in September!
Finally I want to point this out -- from the Credit Suisse analyst report of August 21 – “ACH-3422 is the most advanced nuc in clinical development. ACH-3422 is a uridine nuc. Preclinical studies suggest that ACH-3422 is generally comparable to Sofosbuvir and has a low risk for cardiovascular toxicity. ACH-3422 is currently being evaluated in healthy and HCV patients in a PI trial outside of the US, following in the footsteps of Pharmasset and Idenix.”
