Arbutus Imdusiran Combo Achieves Sustained Undetectable HBsAg in Hep B Short Course

 

• At the end of treatment, 33.3% of patients receiving imdusiran for 48 weeks, interferon (IFN) for 24 weeks and ongoing nucleoside analogue (NA) therapy achieved undetectable levels of HBsAg that were maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment
• Of the patients who have stopped all therapy, six still have undetectable levels of HBsAg and HBV DNA, with two of these patients reaching 12 weeks off all therapy
• All six patients have seroconverted and have high titers of anti-HBsAg antibodies
• These new Phase 2a data were presented at the European Association for the Study of the Liver (EASL) Congress 2024

https://www.biospace.com/article/releases/arbutus-imdusiran-with-short-course-interferon-achieves-sustained-undetectable-hbsag-a-necessity-for-hbv-functional-cure/

Can-Fite Namodenoson for liver cancer granted Orphan Drug and Fast track status from FDA

  Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver cancer. The Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania.

In the former Phase 2 study, conducted in patients with advanced liver cancer, Namodenoson prolonged survival, patients had good quality of life, and in two patients, clearance of peritoneal carcinomas have been reported. In addition, one patient had a long term complete response of more than 7 years.

Liver cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B. According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. The market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

The current double blind, placebo-controlled trial, known as LIVERATION, will enroll 450 patients diagnosed with advanced liver cancer (hepato-cellular carcinoma) and underlying Child Pugh B7 (CPB7) cirrhosis. Patients will be randomized to oral treatment with either 25 mg of Namodenoson or a matching placebo, in a ratio of 2:1 given twice daily as a second- or third-line treatment. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will also be assessed. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated.

https://www.biospace.com/article/releases/can-fite-updates-on-its-advanced-liver-cancer-pivotal-phase-3-study/

Aurinia Presents Safety and Efficacy Profile of LUPKYNIS® for Lupus Nephritis

  Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 taking place in Vienna, Austria June 12-15. The data reinforces previous findings from the AURORA Clinical Program on the safety and effectiveness of LUPKYNIS^® (voclosporin), a second generation calcineurin inhibitor (CNI), for the treatment of adult patients with active lupus nephritis (LN).

A propensity analysis comparing the pooled AURA-LV and AURORA 1 studies to the Aspreva Lupus Management Study (ALMS) suggested that a triple immunosuppressive therapy regimen of LUPKYNIS plus lower-dose MMF and low-dose steroids (≤2 g/day) resulted in earlier and greater reductions in proteinuria, reduced cumulative steroid exposure, and demonstrated comparable rates of overall adverse events, compared to dual immunosuppressive therapy regimens combining high-dose glucocorticoids with either higher doses of MMF or cyclophosphamide.

Safety and efficacy outcomes for propensity-matched patients with active LN from ALMS and AURA-LV/AURORA 1 were assessed at three and six months. Patients who received the LUPKYNIS-based regimen showed >50% reduction in steroid exposure at six months and more frequently achieved a urine protein creatinine ratio (UPCR) of <0.5 mg/mg in a faster median time as compared to the high-dose two drug regimen. These patients also achieved >50% UPCR reduction at any time point in the study significantly earlier than their propensity-matched counterparts in ALMS. These findings support guideline recommendations that LUPKYNIS plus lower-dose MMF and low-dose steroids should be considered as an initial therapy in patients with active LN.

Results from this study were also recently presented at the annual European Renal Association Congress 2024.

https://www.biospace.com/article/releases/aurinia-presents-safety-and-efficacy-profile-of-lupkynis-for-people-with-lupus-nephritis-at-european-alliance-of-associations-for-rheumatology-eular-congress-2024/

Axsome Settles Sunosi® (solriamfetol) Patent Litigation with Unichem

 Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome’s product Sunosi^® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.

As required by law, Axsome and Unichem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against other parties remains pending in the U.S. District Court for the District of New Jersey.

https://www.biospace.com/article/releases/axsome-therapeutics-settles-sunosi-solriamfetol-patent-litigation-with-unichem-laboratories/

Vir Therapy with Elebsiran High Virologic Response and ALT Normalization in Hepatitis D

 

• Preliminary Phase 2 SOLSTICE trial data reinforce the potential of both regimens to be transformative treatments in an area of high unmet medical need
• Conference call scheduled for June 5, 2024, at 6:00 a.m. ET / 12:00 p.m. CEST

A live webcast of the June 5 investor call will be made available on https://investors.vir.bio and a recording will be archived there for 30 days.

The EASL oral scientific presentation will be made available under Events & Presentations in the Investors section of the Vir website following the presentation on June 8^th.

https://www.biospace.com/article/releases/tobevibart-monotherapy-and-combination-therapy-with-elebsiran-achieved-high-virologic-response-and-alt-normalization-in-people-living-with-the-hepatitis-delta-virus-after-12-and-24-weeks-of-treatment/

How do you feel when know-nothings compare your election to emerging markets'?

'US markets get an election preview from India and Mexico'

Ahead of the Trump-Biden showdown this November, two surprise election results this week from opposite ends of the world are reminding investors of the uncertainty that uncertainty in political regimes can bring.

Just south of the US border, Claudia Sheinbaum won a landslide election on Monday to become Mexico's first female president. The presidential win was expected, but the surprise came as her Morena party nearly obtained a supermajority in Congress.

Mexican markets were roiled on concerns the ruling government would be able to push through constitutional amendments. The Mexican stock exchange (^MXX) plummeted nearly 6% Monday, while the peso fell 4% versus the US dollar and a slightly larger amount versus the yen.

Investors searching for yield have been able to borrow at near-zero rates in Japan and buy the peso to earn the 11% short-term interest rates set by their (relatively) hawkish central bank.

Those investors were concerned that a radical government could upset the balance. And in the heavily leveraged world of hedge fund bond trading, volatility itself is often the real enemy — even if investors get the direction "right."

But Tuesday, as it became clear that the supermajority would be narrowly missed, stocks rallied sharply, with the MexBol (as it's called) ending the day in the green, up over 2.5%.

Over in India, anticipation around general elections left investors tense as Prime Minister Narendra Modi's Bharatiya Janata Party faced a heated contest.

Opinion polls over the weekend suggested a landslide win for Modi and his agenda, briefly sending India's benchmark Sensex index (^BSESN) to a record high.

However, as election results were tallied, the margin of victory narrowed, and Indian stocks plunged 7%, erasing $386 billion in market value. Meanwhile, India's currency, the rupee, experienced its most volatile session in a year.

All in all, the fallout from uncertainty was better than feared in both countries. Markets didn't disintegrate.

Investors might be reminded of white-knuckling the 2016 election results in the US as news of Trump's win was digested.

Stock futures traded their maximum limit down by the morning after the polls closed. But after the open, those losses were quickly pared as US markets rallied and never looked back. A 4.5% loss became a 1% win that day. Stocks would end November 2016 up 3.4%.

Four years later, a soon-to-be President Biden won against Trump in the polls, and stocks surged over 10% that November.

Investors can parse historical tendencies six ways from Sunday, but stocks tend to go up over the long term. Politics can get in the way, but it's hard to stop a bull market.

https://finance.yahoo.com/news/us-markets-get-an-election-preview-from-india-and-mexico-morning-brief-100018165.html

Viking Builds Case for NASH Hopeful

 Viking Therapeutics on Tuesday released additional data from its Phase IIb VOYAGE study, showing that its investigational thyroid hormone beta receptor agonist VK2809 could significantly improve histologic outcomes in patients with nonalcoholic steatohepatitis.

At 52 weeks, 63% to 75% of patients treated with VK2809 achieved resolution of nonalcoholic steatohepatitis (NASH) without the worsening of fibrosis. Meanwhile, only 29% of placebo comparators achieved this endpoint, with the effect being statistically significant in favor of the investigational treatment.

In addition, 51.9% and 56.8% of patients given 5-mg and 10-mg VK2809 every other day saw at least a one stage improvement in fibrosis, compared to 34.1% in the placebo group. These treatment effects reached statistical significance with p-values of 0.0304 and 0.0497, respectively.

William Blair analyst Andy Hsieh said in a note to investors called the fibrosis improvement “the most impressive upside surprise” from Tuesday’s data drop, despite the study being underpowered for this endpoint.

Fibrosis is the “best proxy” for long-term NASH outcomes, such as disease progression and death, Hsieh said. “In our view, demonstrating statistically significant fibrosis improvement … further differentiates VK2809 in the [NASH] space and elevates the compound as exhibiting the best-in-class potency among the oral modality.”

The fibrosis outcome could help VK2809 differentiate itself from Madrigal’s Rezdiffra (resmetirom), which became the first FDA-approved NASH treatment in March 2024. According to Hsieh, Rezdiffra was “unable to accomplish” fibrosis improvement in Madrigal’s Phase II trial.

Despite the strong efficacy profile and potential competitive edge, Viking’s shares slipped 15% after the data drop, which Hsieh attributed to the “lack of imminent catalysts and the capital and time investment required for a large global Phase III program.”

In an investor call, CEO Brian Lian said that the company will meet with the FDA later this year to discuss the next possible steps for VK2809.

Designed to have high selectivity for liver tissue, VK2809 is an oral drug candidate that activates the thyroid hormone beta receptor. This mechanism of action boosts the expression of genes involved in lipid metabolism and clearance, improving cholesterol and lipoprotein levels.

Tuesday’s data drop follows a May 2023 readout from VOYAGE, which showed that VK2809 cleared the trial’s primary endpoint, resulting in a significant drop in liver fat.

Stiff competition—from Rezdiffra and other pipeline candidates such as Eli Lilly’s tirzepatide—also contributed to Tuesday’s lukewarm investor reaction, according to Hsieh. In its full-year 2023 business report, Lilly posted 52-week data from a Phase II study showing that tirzepatide resolved NASH without worsening of fibrosis in 74% of patients, as opposed to 13% of placebo comparators.

Novo Nordisk’s semaglutide has also been assessed for NASH, showing disease resolution without worsening of fibrosis in as many as 59% of patients.

https://www.biospace.com/article/viking-builds-case-for-nash-hopeful-with-histological-data/