On Thursday, the American Association for the Study of Liver Diseases, or AASLD, is publishing in the hepatology journal the abstracts for all oral and poster presentation for the upcoming AASLD conference that will take place between November 13-16. Piper Sandler analyst Yasmeen Rahimi sees the Phase 2b NASH data from Novo Nordisk's (NVO) GLP-1 agonist, potential data from the "highly anticipated" TARGET-NASH natural history study, biopsy results from Bristol-Myers' (BMY) peglyated FGF21 analogue from two separate Phase 2b studies, results from Akero Therapeutics (AKRO) Phase 2a's EFX data, and data from Novartis' (NVS) Phase 2b FLIGHT-FXR study as some of the most important abstracts that should be coming out.
KEY ABSTRACTS: In a research note to investors, Piper Sandler analyst Yasmeen Rahimi noted that a key abstract expected at AASLD will detail additional Phase 2b NASH data from Novo Nordisk's GLP-1 agonist, semaglutide. With five separate arms in the study and no biopsy analysis, the analyst foresees a low chance of a clear answer on efficacy, but will look out for safety data and which combo doses make most sense to move forward with in Phase 3. Weight loss and GI effects for semaglutide will serve as a benchmark for what Altimmune's (ALT) dual agonist ALT-801 needs to show as it starts a Phase 1 study in the fourth quarter of 2020, the analyst added.
Her "eyes are also peeled" for potential data from the highly anticipated TARGET-NASH natural history study. Rahimi believes that additional data from the large TARGET-NASH cohort would be valuable for convincing regulators that NITs are predictive of clinical outcomes, which can tilt the benefit-risk ratio in favor of Intercept's (ICPT) OCA ahead of a resubmission of the company's new drug application.
After getting a first glimpse at Digital EASL, the analyst noted that more data from the GALA consortium - which is a longitudinal natural history study of over 1k Alagille patients with genotype data, pathology and response to surgical intervention - at AASLD could add to the growing consensus that Alagille patients have little recourse to stemming the disease. GALA could further shine the spotlight on how the sustained biomarker reductions and itch improvement for Mirum's (MIRM) maralixibat could go a long way to preventing liver transplant and bettering patient's quality of life, she contends.
The analyst also expects to see biopsy results from Bristol Myers peglyated FGF21 analogue from two separate Phase 2b studies: 24-week Phase 2b in 160 F3 NASH patients with primary endpoint of percentage of participants achieving over 1 stage improvement in fibrosis without worsening of NASH and NAS activity score- FALCON 1 study; 48 week Phase 2b of 152 biopsy proven F4 patients with primary endpoint analysis of 1- improvement of fibrosis without worsening of NASH – FALCON 2 study. Rahimi foresees "encouraging results" from FALCON 2 as likely to put EFX and BIO89-100 further on the cirrhosis therapeutic map.
The analyst also highlighted the full results from Akero Therapeutics Phase 2a's EFX data. She looks forward to more granular histological data and also efficacy between F2 and F3 patients, which in her view provides strong mechanistic support for achieving fibrosis benefits in F4 patients. While there may not be topline data from Cohort C until early 2020, Rahimi believes the detailed histological analysis from Phase 2a F2/F3 patients along with FALCON 1 and FALCON 2 data will provide clues about EFX's anti-fibrotic benefit in cirrhotic patients.
With positive interim non-invasive biomarker results from Part C of Novartis' Phase 2b FLIGHT-FXR study reported at last year's AASLD, the analyst is anticipating potentially seeing full 48-week biopsy-based data at this year's AASLD. Rahimi noted that FLIGHT-FXR readout, consisting of paired biopsy data at 48 weeks for two doses of FXR agonist tropifexor, is likely to cement OCA’s place as lead FXR contender in NASH.
Additionally, the analyst told investors to "not sleep on an outpour of PPAR data." In PPAR news, she is on the lookout for two potential datasets from Cymabay (CBAY) for seladelpar. Following topline readout of its Phase 3 ENHANCE study on August 3, 2020, Rahimi sees a chance that Cymabay could present the full ENHANCE dataset at AASLD. More granularity around itch reduction as well as seladelpar's effects and timecourse of biomarker reductions would add to momentum around seladelpar in primary biliary cholangitis, or PBC, as Cymabay heads toward another Phase 3 trial, she said. The analyst believes that with complete visibility into the totality of Phase 3 data from Cymabay, investigators will be fully briefed on seladelpar and will be significantly likely to engage in enrolling an upcoming Phase 3 PBC trial for seladelpar. She also thinks there is also a chance Cymabay provides a presentation walking through the atypical lesions observed in its terminated Phase 2 NASH study that prompted the seladelpar clinical hold. Bringing clarity to the biopsy signals observed in the Phase 2 NASH study could be a lynchpin to dispel any hangups and drive forward strategic discussions about how seladelpar can be further utilized in NASH clinical testing, she added.
Even with recent topline readout of 89bio's (ETNB) Phase 1b/2a study, the analyst still thinks there is a chance of seeing a presentation that divulges a key question on investors' minds regarding the difference in MRI-PDFF response when separating BIO89-100 patients between presumptive NASH patients and NASH patients. As investors try to benchmark 89bio's Phase 1b/2a results against the FGF21 field, all eyes are on insuring that BIO89-100’s effects translate well across the NAFLD-to-NASH continuum of patients, Rahimi contended.
As Albireo (ALBO) continues to "march forward," a deeper read of the company's PEDFIC 1 results, especially around the difference in serum bile acid and itch response between dose levels and PFIC subtype, are key questions on the analyst's radar. Rahimi noted that in the leadup to regulatory filing for odevixibat in PFIC by early 2021, "all eyes are on trying to best predict the potential label across PFIC subtypes."
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Novo Nordisk
-0.845 (-1.20%)
Novartis
-0.145 (-0.17%)
Bristol Myers
+0.48 (+0.80%)
Akero Therapeutics
-0.1499 (-0.48%)
Altimmune
+ (+0.00%)
Intercept
+0.75 (+1.80%)
Mirum Pharmaceuticals
-0.1 (-0.51%)
Acquired by GILD
-0.02 (-0.28%)
89bio
+0.25 (+1.00%)
Albireo Pharma
+1.3 (+3.98%)