Replies to post #87555 on Biotech Values

[bxjwn9ru]

ACHN - Nice one McBio. Was this news expected this early as i had them down for q1 2010?

[tony111]

ACHN got one more quarter of cash to burn. To me the release of preliminary news is likely a pump and offering IMO.

[mcbio]

Comments on ACH-1625 results

This looks like great news for the company, albeit preliminary as there are still a few cohorts in the Phase 1b to go (next data due early in January).

1. I'm curious how the mean 5-day log drop of 3.94 log10 compares to telaprevir and the other PIs. There is no way to do an apples-to-apples comparison I assume as most of the other HCV PIs measured their initial PoC potency data at 3 days I believe.

2. Perhaps more important than the potency data (as we have discussed before on here), the initial safety data in HCV-infected patients looks clean.

3. A key question for me centers around the fact that this initial data is from BID dosing. The goal is for ACH-1625 to be dosed QD, as that has been perceived as a potential differentiating advantage for ACH-1625. The BID dose was 600mg so I'm assuming that at least one of the remaining cohorts is testing ACH-1625 at a higher potency and at QD dosing.

4. It is noted that viral load remained suppressed for at least 7 days after dosing was completed. Isn't it normal for viral loads to quickly rebound in these studies? If so, I presume that this is potentially a good differentiating characteristic for ACH-1625.

[DewDiligence]

ACHN’s VC shareholders did some heavy selling on Dec 16-18, immediately after ACHN (prematurely) reported data from the ACH-1625 phase-1b trial. The total amount sold by three VC shareholders on Dec 16-18 was about 1.75M shares worth about $5.8M:

http://sec.gov/Archives/edgar/data/1070336/000101297509000358/xslF345X03/edgar.xml
http://sec.gov/Archives/edgar/data/889232/000118143109057864/xslF345X03/rrd260348.xml
http://sec.gov/Archives/edgar/data/1033508/000093244009000720/xslF345X03/edgar.xml

No further investigation is needed to understand why ACHN jumped the gun on reporting data from the first phase-1b cohort.

[mcbio]

ACHN - Additional Positive Phase 1b Results for ACH-1625

http://finance.yahoo.com/news/Achillion-Announces-pz-3158812622.html?x=0&.v=1

Achillion Announces Additional Positive Phase 1b Data With ACH-1625 to Treat Hepatitis C
Second Dosing Cohort Achieves 4.25log10 Viral Load Reduction With Continued Safety and Tolerability

NEW HAVEN, Conn., Jan. 11, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News) today reported additional preliminary data from its on-going phase 1b clinical trial of ACH-1625 which demonstrated that the second dosing cohort receiving treatment with ACH-1625 achieved a mean 4.25 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.

Proof-of-Concept Study Results

Today, Achillion announced additional results from a phase 1b clinical study of ACH-1625. HCV-infected subjects in this second dosing cohort (n=9, randomized to 6 active drug, 3 placebo) received doses of 500 mg BID of ACH-1625. Preliminary results showed that a mean reduction in viral load of 4.25 log10 was achieved in the treatment group, as compared to a mean reduction of 0.29 log10 in the placebo group. Safety results from this dosing group were similar to those observed in both the phase 1a segment of the trial and in the first cohort of HCV-infected subjects. Sustained viral suppression was also similar to the first cohort, with patients maintaining a mean reduction of more than 3.0 log10 from baseline through day 12, 7 days after dosing was completed and the last day of viral load measurement in the study.

In December 2009, Achillion announced proof-of-concept data from this phase 1b study. Subjects in the first dosing cohort of HCV-infected patients received doses of 600 mg BID (n=9, randomized to 6 active drug, 3 placebo). Preliminary results showed that a mean reduction in viral load of 3.94 log10 was achieved in the treatment group, as compared to a mean reduction of 0.22 log10 in the placebo group. All subjects in the treatment group had viral load decline between 3.0 and 4.5 log10, and two subjects reached undetectable levels of HCV RNA. Safety results from this dosing group were similar to those observed in the phase 1a segment of the trial. There were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0 log10 from baseline through day 12, the last day of viral load measurement in the study.

"We are quite pleased to see that these data corroborate and support the preliminary positive data from the first cohort of the study even at this lower dose. ACH-1625 continues to demonstrate a dramatic reduction in viral load after 5 days of monotherapy, and importantly, showed continued suppression of viral load after drug discontinuation. This is significant as it could be a distinguishing feature and competitive advantage for our compound in comparison to other HCV therapeutics," said Michael D. Kishbauch, Chief Executive Officer of Achillion.

"With continued robust antiviral activity even at this lower dose, we are encouraged now to explore both lower doses and different dosing schedules. We expect to conduct studies of additional doses under this protocol over the next few months and to release additional data thereafter, potentially at the upcoming EASL (European Association for the Study of Liver Disease) meeting in April 2010 in Vienna," added Dr. Elizabeth Olek, Chief Medical Officer of Achillion.

About ACH-1625

ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.

In phase 1a safety studies with ACH-1625, subjects in the single ascending dose (SAD) segment of the study received single doses ranging from 50 mg to 2000 mg. Subjects in the phase 1a multiple ascending dose (MAD) segment of the study received 5 days of ACH-1625 up to a maximal dose of 2000 mg per day. Preliminary data from the SAD and MAD trial segments demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.

About HCV

The hepatitis C virus (HCV) is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.

About Achillion

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.