ALBO Drops NASH Drug Development, FDA Says No To Filgotinib, SUPN On Watch, Vanda & ODYSSEY

biotech aug19

Today's Daily Dose brings you news about another headstone in the graveyard of NASH drugs, ADC Therapeutics' near-term catalysts, Gilead's Filgotinib being turned down by the FDA, Sorrento terminating its CFO, Supernus' regulatory catalyst for November, and Vanda's progress in COVID-19 treatment Tradipitant.

Read on…

1. Albireo Discontinues NASH Drug Development

Albireo Pharma Inc. (ALBO) has decided not to pursue the development of its drug candidate Elobixibat in the indications of nonalcoholic fatty liver disease, or NAFLD, and nonalcoholic steatohepatitis, or NASH, based on the results of its proof-of-concept phase II trial.

Although the trial achieved the primary endpoint of a reduction in LDL-C with a clinically meaningful effect with Elobixibat, it did not achieve proof-of-concept for other key NASH measures such as a change in liver fat by imaging, and in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, the biomarkers of NAFLD and NASH.

Elobixibat is currently approved in Japan for chronic constipation.

Albireo has several milestones for the remainder of 2020, and the near-term anticipated event is the release of topline results from a pivotal phase III trial of Odevixibat in progressive familial intrahepatic cholestasis, dubbed PEDFIC 1, in the coming weeks.

ALBO closed Tuesday's trading at $27.01, up 0.11%. In after-hours, the stock was down 2.52% at $26.33.

2. ADC Therapeutics to File Lonca BLA

ADC Therapeutics SA (ADCT) has a couple of catalysts lined up for the coming months.

The lead investigational drug is Loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A Biologics License Application for Loncastuximab tesirine for DLBCL is expected to be filed with the FDA in the second half of 2020. A pivotal phase II trial of Loncastuximab tesirine in follicular lymphoma is planned for initiation in the first half of 2021.

Cami, the second lead product candidate, is under a pivotal phase II trial in relapsed or refractory Hodgkin lymphoma, with interim results expected in the first half of 2021.

ADCT closed Tuesday's trading at $39.00, up 0.98%.

3. Akcea/Ionis to Present Positive AKCEA-APOCIII-LRx Trail Data on Aug.29

Akcea Therapeutics Inc. (AKCA), a majority-owned affiliate of Ionis Pharmaceuticals Inc., and Ionis Pharmaceuticals, Inc. (IONS) are scheduled to announce positive data from their phase II study of AKCEA-APOCIII-LRx for the treatment of hypertriglyceridemia at the upcoming ESC Congress 2020 on August 29.

AKCEA-APOCIII-LRx was discovered by Ionis and is being co-developed by Akcea and Ionis.

In January of this year, the company had reported positive topline results from the phase II study of AKCEA-APOCIII-LRx in the treatment of patients with hypertriglyceridemia who are at risk for or have established cardiovascular disease (CVD). The study met the primary endpoint of significant triglyceride-lowering and multiple secondary endpoints with a favorable safety and tolerability profile.

IONS closed Tuesday's trading at $53.65, down 0.63%.

4. FDA Denies Approval for Filgotinib

The FDA has declined to approve Gilead Sciences Inc.'s (GILD) Filgotinib, proposed for the treatment of moderately to severely active rheumatoid arthritis.

In its complete response letter issued to Gilead, the FDA has requested data from MANTA and MANTA-RAy studies before Filgotinib could be approved. The MANTA and MANTA-RAy studies are designed to assess whether Filgotinib has an impact on sperm parameters. The regulatory agency has also has expressed concerns regarding the overall benefit/risk profile of the Filgotinib 200 mg dose.

The topline results from the MANTA and MANTA-RAy studies are anticipated in the first half of 2021.

Gilead and Galapagos NV (GLPG) are collaborative partners in the global development and commercialization of Filgotinib in rheumatoid arthritis and other inflammatory indications. Gilead is responsible for the potential commercialization of Filgotinib in the U.S.

However, things are bright for Filgotinib on the other side of the Atlantic.

Filgotinib received a positive opinion from the European Medicines Agency's panel last month, and a final decision is expected this quarter.

GLPG closed Tuesday's trading at $188.08, down 2.37%.

5. Sorrento CFO Booted Out

Sorrento Therapeutics Inc. (SRNE) has removed Jiong Shao who served as the company's Executive Vice President and Chief Financial Officer. Najjam Asghar has been appointed the company's Chief Financial Officer, effective August 18.

The company had reported its second-quarter financial results earlier this month. Total revenues, including product revenue and service revenue, were $9 million in the recent second quarter compared to $6.5 million in the year-earlier period.

In response to the global COVID-19 pandemic, Sorrento is developing potential coronavirus antiviral therapies and vaccines, including ACE-MAB, COVIDTRAP, COVI-MAB, COVI-GUARD, COVI- SHIELD, and T-VIVA-19. The company is also developing COVID-19 diagnostic products, including COVI-TRACK for detecting the presence of antibodies against SARS-CoV-2 in patient blood samples, and COVI-TRACE for detecting the presence of SARS-CoV-2 in patient saliva samples. SARS-CoV-2 is a virus that causes COVID-19.

SRNE closed Tuesday's trading at $12.28, up 1.49%. In after-hours, the stock was down 13.76% at $10.59.

6. It's time to pay attention to Supernus

Supernus Pharmaceuticals Inc. (SUPN) is all set to submit its New Drug Application for SPN-830 for the continuous prevention of OFF episodes in Parkinson's disease in the fourth quarter of 2020.

The company's investigational drug SPN-812, proposed for the treatment of ADHD in children and adolescents with ADHD is under FDA review, with a decision anticipated on November 8. SPN-812 is also being tested in adults with ADHD in a phase III trial and enrollment is expected to be completed this year with topline data anticipated in the first quarter of 2021.

SUPN closed Tuesday's trading at $25.05, up 0.60%. In after-hours, the stock was up 2.67% at $25.72.

7. Vanda Reveals Early Results from ODYSSEY Trial

Vanda Pharmaceuticals Inc.'s (VNDA) ongoing phase III trial of Tradipitant in the treatment of neurogenic inflammation of the lung secondary to COVID-19 infection has yielded promising results in the interim analysis.

The ongoing study, dubbed ODYSSEY, is expected to enroll 300 patients, and as of July 15, 2020, sixty patients had enrolled and completed the study.

The interim analysis, based on the first 60 patients, suggests that after 7 days of treatment, patients treated with Tradipitant recovered earlier than those receiving placebo, which was statistically significant. At day 28 of the study, Tradipitant showed a numerical benefit over placebo with an earlier median time to recovery. Similar overall rates of improvement and mortality were observed for Tradipitant and placebo at day 28.

Commenting on the data, Mihael H. Polymeropoulos, President and CEO of Vanda, said, " These results, albeit preliminary, are exciting, offering the promise of a significant contribution in the treatment of COVID-19 and the prospect of making tradipitant part of the standard of care in accelerating recovery for patients with COVID-19 pneumonia."

VNDA closed Tuesday's trading at $10.69, down 8.20%.

8. Stocks That Moved On No News

Verrica Pharmaceuticals Inc. (VRCA) closed Tuesday's trading at $8.56, up 14.67%.

Solid Biosciences Inc. (SLDB) closed Tuesday's trading at $3.05, up 13.81%.

Beam Therapeutics Inc. (BEAM) closed Tuesday's trading at $25.63, up 12.41%.

Precipio Inc. (PRPO) closed Tuesday's trading at $2.57, down 20.92%.

Biofrontera AG (BFRA) closed Tuesday's trading at $11.51, down 16.96%.

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