Drugmakers Set to Face Off Over Obesity-Led Liver Diseases

(Bloomberg) -- This weekend’s meeting of liver doctors and drugmakers in San Francisco promises fireworks where heavy- and light-weight hitters will duke it out for the title of best new molecules.

The multibillion-dollar market potential for obesity-driven liver disease has prompted biopharmaceutical companies large and small to chase after treatments. Intercept Pharmaceuticals Inc.’s Ocaliva, already prescribed for a bile-duct disorder, is seen as the most likely candidate to win first approval in the U.S. for patients with a fatty liver ailment known as NASH, or non-alcoholic steatohepatitis.

Competition isn’t far behind.

Large-caps Gilead Sciences Inc. and Novartis AG are developing therapies similar to Ocaliva, which belongs to a class of drugs known as FXR agonists. The companies will be presenting updated results at the American Association for the Study of Liver Diseases (AASLD) meeting, which kicks off Friday. Small-cap Enanta Pharmaceuticals Inc. will also present. And while initial abstracts from Gilead disappointed investors last month, some analysts see Novartis’s tropifexor as more promising.

The other battleground will be a new class of treatments known as THR-beta agonists. Results being presented by Madrigal Pharmaceuticals Inc. and Viking Therapeutics Inc. may hint at who could be the mid-cap champion.

Analysts say investors can expect to hear more at the meeting on future NASH diagnostics to find patients and how drugs for the ailment could be priced, as well as how awareness about the disease can be spread ahead of drugs reaching the market. Beyond NASH and fatty liver disease, Wall Street analysts also will be looking at results for therapies for primary biliary cholangitis (PBC) -- Ocaliva’s current indication -- as well as drugs for hepatitis B and C and primary sclerosing cholangitis (PSC).

Companies presenting data include:

Novartis
  • Novartis recently joined with Pfizer to investigate combination therapies in NASH, including planned combo studies of tropifexor. Raymond James analyst Steven Seedhouse says tropifexor “looks like a competitive threat, Gilead’s GS-9674 not so much.”
  • Tropifexor late-breaking poster is set to be presented Monday, Nov. 12; combination data with Allergan’s cenicriviroc on Sunday.


Gilead
  • While Gilead’s GS-9674 uses a similar mechanism to Ocaliva, Roth Capital’s Yasmeen Rahimi sees the Intercept drug’s activation as potentially better. Gilead’s FXR agonist “underperforms” across several fronts with a similar safety profile, while being five years behind Ocaliva in development. Look for “further corroborating biomarker evidence of this drug’s activity and potential differentiation (or lack thereof),” RBC’s Brian Abrahams said.
  • In addition to posters on GS-9674 in NASH (Friday) and PSC (Sunday), there will be results for GS-0976, hepatitis B therapies as well as Gilead’s selonsertib at a plenary session on Monday.

Intercept

  • Intercept will have multiple posters at the AASLD meeting, but investors are focused on late-stage “Regenerate” study results expected early next year. While Raymond James’s Seedhouse sees the study as likely to succeed, the meeting may be negative for Intercept as there are “too many competitive developments in NASH,” including from Novartis’s FXR.

Madrigal Pharmaceuticals

  • Madrigal has lost more than a third of its value since June 6, when shares hit a five-year high, as investors have questioned deal speculation and the company’s results. “We think AASLD will bring either a lack of answer, or unfavorable answers to those questions,” Seedhouse wrote. He predicts a “data gap” after the meeting as investors await late-stage results from a not-yet-started study.
  • Madrigal’s Phase 2 results for MGL-3196 are due at a plenary session on Monday morning at 8:15 local time (11:15 a.m. in New York).

Viking Therapeutics
  • “Data released at the conference will likely provide credence to VK2809’s safety and efficacy profile and corroborate the previously announced positive results,” William Blair’s Andy Hsieh wrote, while Seedhouse said the meeting may resolve “too good to be true” suspicions.
  • Viking Phase 2 data in fatty liver disease to be presented as a late-breaker on Monday at 3pm in San Francisco

Galmed Pharmaceuticals

  • Roth Capital’s Rahimi called Galmed “one of the most undervalued NASH companies,” despite the company’s “robust” results. Bears have focused on Aramchol’s failure to show a statistically significant change on a composite measure of liver disease, known as the NAFLD Activity Score. Focus will be on subgroup analyses of histology and lobular inflammation, she said.
  • Galmed to make late-breaker presentation on “Arrest” results for Aramchol on Tuesday at 8am local time.

Cymabay Therapeutics
  • Results from Cymabay’s seladelpar as well as the generic fenofibrate “could shape the competitive landscape” for Ocaliva in PBC, Abrahams of RBC wrote. The company will be presenting late-breaking abstracts on seladelpar on Monday afternoon in San Francisco and host a related reception later that evening.

Arrowhead Pharmaceuticals

  • Hepatitis B could gain more attention after Johnson & Johnson’s deal with Arrowhead, JMP’s Liisa Bayko said. Other companies in the space that may be affected by results at the meeting include Assembly Biosciences, Spring Bank Pharmaceuticals and Alnylam Pharmaceuticals.
  • Arrowhead late-breakers on its hepatitis B assets to be presented on Monday.

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