Next week could see some biotech stocks move on the annual EASL meeting.
These stocks do not meet the stringent requirements of stocks in the Premium service but could be profitable trades driven by data release catalysts.
A4250, PEDFIC-1, for liver disease. Phase 2 data to be presented at EASL on April 12, 2019.
Albireo Pharma announced that results from its completed Phase 2 clinical trial of lead product candidate A4250 in children with Alagille syndrome and biliary atresia have been selected for presentation at the European Association for the Study of the Liver (EASL) The International Liver Congress (ILC) 2019, being held April 10-14, 2019, at the Reed Messe Wien Exhibition & Congress Center in Vienna, Austria.
The Phase 2 trial evaluated A4250 in children with cholestatic liver diseases including Alagille syndrome and biliary atresia. Trial results for patients with Alagille syndrome have been selected for an oral presentation on Saturday, April 13, and results for patients with biliary atresia will be presented during a poster session on Friday, April 12.
Details of the presentations are as follows:
Title: Effects of the ileal bile acid transport inhibitor A4250 on serum bile acids, pruritus and sleep in patients with Alagille syndrome: Phase 2 study results
Presentation Number: PS-194
Session: Parallel session: Clinical developments in rare liver disease
Date / Time: Saturday, April 13, 8:30 a.m. CEST
Presenter: Dr. Ulrich Baumann, Professor of Pediatric Gastroenterology and Hepatology, Hannover Medical School; Hannover, Germany
Title: Effects of the ileal bile acid transport inhibitor A4250 on pruritus and serum bile acids in
patients with biliary atresia: Phase 2 study results
Presentation Number: FRI-060
Session: Poster: Autoimmune and chronic cholestatic liver disease: Clinical aspects
Date / Time: Friday, April 12, 9 a.m. – 5 p.m. CEST
Presenter: Dr. Ekkehard Sturm, Head of Pediatric Gastroenterology-Hepatology, Liver and Intestinal Transplantation, Children’s Hospital, University of Tuebingen; Tuebingen, Germany
Also at EASL, the following presentation by Daan van Wessel, University Medical Center Groningen, Netherlands, on April 13 at 8:45 a.m. CEST is relevant to the development of A4250: “Predicting long-term outcome after surgical biliary diversion in BSEP-deficiency patients: Results from the NAPPED consortium” (presentation number PS-195). Notably, the NAPPED consortium data demonstrate the impact of surgical biliary diversion on serum bile acids in bile salt export pump (BSEP)-deficient patients with mild or moderate PFIC type 2. NAPPED is supported by an unrestricted grant from Albireo.
ALBO stock does not present a decent entry opportunity at the moment. Price movement has been a little bit too extended to the upside to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first.
Givosiran for acute hepatic porphyrias. Phase 3 data released on March 6, 2019 met primary endpoint and showed double the results of the placebo group. Presentation at EASL April 13, 2019. Rolling NDA has been initiated.
Alnylam Pharmaceuticals announced that the Company and its collaborators will present at the European Association for the Study of the Liver(EASL) 54th Annual International Liver Congress™, being held April 10-14, 2019 in Vienna, Austria. Presentations include full clinical results from the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) in development for the treatment of acute hepatic porphyria (AHP). The Company announced positive topline results from the ENVISION Phase 3 study earlier this month.
- ENVISION, a Phase 3 Study to Evaluate Efficacy and Safety of Givosiran, an Investigational RNAi Therapeutic Targeting Aminolevulinic Acid Synthase 1, in Acute Hepatic Porphyria Patients
Oral presentation, Saturday, April 13, 2019 at 10:15 am CET
Lead authors: Balwani M, Gouya L, Rees DC
- Acute Hepatic Porphyria Disease Manifestations and Daily Life Impacts in EXPLORE International, Prospective, Natural History Study
Poster presentation, Friday, April 12, 2019 starting at 9:00 am CET
Lead authors: Ventura P, Gouya L, Balwani M
- Management of Acute Hepatic Porphyria (AHP) Attacks in Europe and United States: EXPLORE International, Prospective, Natural History Study
Poster presentation, Friday, April 12, 2019 starting at 9:00 am CET
Lead authors: Sardh E, Balwani M, Gouya L
The ENVISION study of givosiran has been selected for inclusion in the ‘Best of ILC’, a resource prepared by EASL to highlight the most noteworthy contributions to the scientific program each year.
ALNY stock has formed a great setup pattern. We see reduced volatility while prices have been in a bullish continuation pattern. A pullback is taking place, which may present a nice opportunity for an entry. There is a resistance zone just above the current price starting at $93.45. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $87.43, a stop order could be placed below this zone. We also are seeing bullish Pocket Pivot signals.
VK2809 for hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Phase 2 additional NAFLD data to be presented at EASL on April 11, 2019.
The company recently received additional data from the low-dose 5 mg cohort in the Phase 2 trial of VK2809 trial in NAFLD and hypercholesterolemia. The results demonstrated that patients receiving VK2809 experienced statistically significant reductions in liver fat content relative to placebo, as well as statistically significant improvements in response rates, defined by the proportion of patients experiencing at least a 30% or 50% relative reduction in liver fat, compared with placebo. Consistent with prior data from the 10 mg cohorts, VK2809 was well tolerated when dosed at 5 mg daily, and no serious adverse events were reported among patients receiving either VK2809 or placebo. These results will be presented at the Late-Breaker poster session at the upcoming annual meeting of the European Association for the Study of Liver (EASL), April 11-14, 2019 in Vienna, Austria.
“The past year has been a transformative period for Viking, and we are excited to continue this momentum in 2019,” stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. “We were particularly pleased in 2018 to have presented positive Phase 2 data from our novel thyroid receptor beta agonist VK2809 in non-alcoholic fatty liver disease at the AASLD conference, and honored that these results were featured in the Best of AASLD conference highlights. We plan to present additional, new results from this study at the upcoming EASL conference in April, and remain on-track to file an IND to initiate a study in biopsy-confirmed NASH later this year. In addition, pre-IND work for our second thyroid receptor agonist VK0214 continues to progress, and we plan to file an IND to initiate clinical development by the end of the year. Thanks to successful fundraising efforts in 2018, we ended the year with more than $300 million on our balance sheet, and are now capitalized to reach major inflection points for multiple programs. Entering 2019, we are focused on executing our operating plans and enthusiastic about the future development of our pipeline.”
VKTX stock is not a good setup at the moment. Price movement has been a little bit too volatile to find a nice entry and exit point. It is probably a good idea to wait for a consolidation first.
Inarigivir and Vemlidy, ACHIEVE, for Hepatitis B (HBV). Phase 2 full data to be presented at EASL April 12, 2019.
On March 28, 2019, Spring Bank Pharmaceuticals announced the acceptance of a late breaker oral presentation and a poster presentation at The International Liver Congress™ (ICL), the Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria, April 10-14, 2019.
The late-breaker oral presentation by Professor Man-Fung Yuen, Chief of Gastroenterology and Hepatology, University of Hong Kong, and Principal Investigator of the ACHIEVE trial, scheduled for General Session II and Award Ceremony I, will describe the final top-line results from all inarigivir (IRIG) ACHIEVE trial cohorts, including the 200mg dosing cohort. As mentioned in the preliminary abstract published by the ICL yesterday, the full ACHIEVE trial and the IRIG 200mg dosing cohort met the primary endpoints of safety and HBV DNA reduction at week 12 after IRIG monotherapy. Spring Bankobserved a dose-dependent response in HBV DNA reduction in both HBeAg-positive and HBeAg-negative patients with a maximal reduction of 3.26 log10. The full data on secondary virological endpoints, including HBV RNA, HBsAg and HBcrAg for all patients, was not available for the published preliminary abstract, but will be presented for the full 24-week treatment period by the principal investigator of the ACHIEVE trial at the ICL. This information remains subject to the ICL embargo policy and will be made available at the time of presentation.
Professor Stephen Locarnini, Head of Research & Molecular Development at the Victorian Infectious Diseases Reference Laboratory and Principal Investigator of the Virology Core for the ACHIEVE trial, will present the poster describing the antiviral activity of IRIG in HBV clinical isolates consisting of capsid inhibitor (CpAM) and nucleoside analog resistant variants. This data indicates that IRIG could be used as rescue or combination therapy for nucleoside/CpAM-resistant failures.
|Session:||General Session II and Award Ceremony I|
|Title:||Ascending dose cohort study of inarigivir – A novel RIG I agonist in chronic HBV patients: Final results of the ACHIEVE trial|
|Date/Time:||Friday, April 12, 2019 at 10:15 a.m. CET|
|Presenter:||Prof. Man-Fung Yuen, University of Hong Kong|
|Session:||Viral hepatitis B/D: Therapy|
|Title:||The novel antiviral agent inarigivir inhibits both nucleos(t)ide analogue and capsid inhibitor resistant HBV in vitro|
|Date/Time:||Friday, April 12, 2019 from 9:00 a.m. to 5:00 p.m. CET|
|Presenter:||Prof. Stephen Locarnini, Victoria Infectious Diseases Reference Laboratory|
SBPH presents an ok setup. We see reduced volatility while prices have been consolidating in the most recent period. There is a resistance zone just above the current price starting at $10.86. Right above this resistance zone may be a good entry point. There is a support zone below the current price at $10.47, a stop order could be placed below this zone.
Disclosure: I do not hold any position in any stock mentioned in this article.