Hepion starts Phase 2b ‘ASCEND-NASH’ Trial

 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has screened the first subject in the ASCEND-NASH clinical trial. The trial is being conducted at up to 121 sites in seven countries, with 85 of the sites located within the U.S.

ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study to evaluate the safety and efficacy of rencofilstat in 336 subjects dosed for 12 months. Subjects included in the trial will be either F2 or F3 biopsy-confirmed, with enrollment of F3 subjects of at least 60%, to focus on NASH subjects with more advanced fibrosis. Subjects will receive either placebo or rencofilstat, administered orally once daily at doses of 75, 150, or 225 mg (n=84 subjects/cohort). Endpoints will evaluate improvements in both fibrosis and steatosis, with the overall study primary endpoint being an improvement of fibrosis score by one point without a worsening of steatosis, or an improvement of steatosis without worsening of fibrosis. Although the main trial endpoint is histologic and determined by changes in the biopsy, numerous other non-invasive markers (“NIM”) will be assessed, including NASH efficacy biomarkers, magnetic resonance elastography (“MRE”), and multiomics (e.g. proteomics and transcriptomics).

https://finance.yahoo.com/news/hepion-pharmaceuticals-announces-initiation-phase-120000431.html

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Longeveron Gets FDA Fast-Track Designation for Lomecel-B in Heart Defect

 Longeveron Inc. on Wednesday said the U.S. Food and Drug Administration granted fast-track designation to Lomecel-B, the company's lead program, for the treatment of hypoplastic left heart syndrome in infants.

The Miami clinical-stage biotechnology company is currently studying Lomecel-B in a Phase 2a trial for the rare and life-threatening congenital heart defect, which affects about 1,000 infants a year.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Longeveron previously received the FDA's orphan-drug and rare-pediatric-disease designations for Lomecel-B in hypoplastic left heart syndrome.

https://www.marketscreener.com/quote/stock/LONGEVERON-INC-118907392/news/Longeveron-Gets-FDA-Fast-Track-Designation-for-Lomecel-B-in-Heart-Defect-41661626/

COVID-19 money could run out in January, says US government

 Access to free COVID-19 test kits is coming to an end in the US this week – but that could also extend to vaccines and drug therapies in the coming months unless Congress votes for additional funding, according to senior Health and Human Services (HHS) official.

In a blog post, assistant secretary for preparedness and response Dawn O’Connell writes that the federal government has “always intended to transition this work to the commercial market and have been planning for that transition.”

The timelines are shortening however, and HHS now anticipates that as early as January 2023 it will have no money left to purchase and distribute COVID-19 vaccines, and will run out of AstraZeneca’s antibody-based prevention therapy Evusheld around the same time.

Stocks of oral antivirals are also under stress, with Merck & Co’s Lagevrio (molnupiravir) expected to be depleted in the first half of 2023, while Pfizer’s Paxlovid (nirmatrelvir/ritonavir) will start to run out in the middle of next year, according to O’Connell.

One of the earlier drugs used to treat COVID-19 – Eli Lilly’s bebtelovimab, which was authorised in February by the FDA for mild-to-moderate COVID-19  at risk of getting worse, has already made the switch to the commercial marketplace.

As soon as the government stops paying for the medicines, US consumers will have to either obtain the medicines via their health insurance policies, or pay for them out of pocket. However, the US has already placed orders for 171 million updated vaccines that have been modified to protect against the prevailing Omicron strain of SARS-CoV-2.

This week, HHS met with representatives from state and local governments, healthcare providers and insurers, pharma manufacturers, and patient advocates to examine the shift to commercial supply, similar to the way seasonal flu shots are administered.

“COVID-19 funding continues to be urgently needed for a range of critical response needs, including the development of next-generation vaccines, therapeutics, and tests,” according to O’Connell, with money also needed to wind down the current system and avoid any gaps in access as commercial supply gets into gear, and continue to support access for people without adequate insurance.

“We have been grateful for the bipartisan Congressional support of our response efforts, but it has been more than 530 days since we last received new funding for COVID-19 and without additional funds it will be difficult to continue procuring and distributing these countermeasures.”

Talks aimed at providing additional funding have been at an impasse in Congress with Democrats and Republicans both blocking proposals by the Biden administration.

The 171 million doses already paid for will cover early demand for booster shots as autumn immunisation gets underway with Omicron-directed shots from Moderna and Pfizer/BioNTech – just approved by the FDA – but won’t be enough to cover the entire adult US population of around 260 million.

https://pharmaphorum.com/news/covid-19-money-could-run-out-in-january-says-us-government/

Futura eyes FDA filing as topical ED drug passes phase 3 test

 Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month.

The results of the FM71 trial of MED3000 showed that the topical gel formulation achieved a significant improvement in erectile function compared to baseline at 24 weeks, across the range of mild, moderate and severe ED.

The treatment also has a 10-minute onset of action that, according to Future, is “demonstrably faster” than the orally-dosed active comparator (tadalafil) used in the study, and also avoids the potential side effects of oral drugs for ED, which can take 30-60 minutes to take effect.

The company says MED3000 has a unique evaporative mode of action, stimulating nerve endings to cause an erection. It is actually the control formulation used in clinical development of its original product MED2005, which contained glyceryl trinitrate as an active ingredient.

The therapy has already been approved in the EU and UK as a medical device, and Futura is hoping to secure FDA approval of the formulation in the first quarter of 2023 as an over-the-counter (OTC) product.

The FM71 trial was carried out in 96 male subjects with organic and psychological ED, with the gel compared to oral tadalafil (5 mg) over a 24-week period using endpoints agreed with the FDA.

After 24 weeks, significantly more men taking MED300 reported an improvement on the questionnaire-based International Index of Erectile Function-Erectile Function (IIEF-EF) domain score compared to baseline.

Futura’s earlier phase 3 study (FM57) only followed subjects for 12 weeks and the FDA specifically asked that the confirmatory trial be longer to allow the durability of response to be gauged.

Both MED3000 and tadalafil exceeded the minimal clinically important differences at all time points and for all ED severities, however, overall tadalafil showed a greater improvement in erectile function than MED3000.

So far, it hasn’t been launched, although Futura has lined up commercial partners for the product in many markets, including with Cooper Consumer Health in the EU and UK, Menarini in South Korea, m8 Pharma in Latin America, and Labatec Pharma in certain Gulf states.

However, “the USA remains the largest market opportunity globally for ED treatments,” said Futura’s chief executive, James Barder.

“In the USA all clinically proven oral ED therapies are prescription-only and therefore MED3000 has the potential to be a significant innovation with its key differentiator of a rapid speed of onset and by creating a major new OTC category for ED treatment,” he pointed out.

The company said in June that it ended 2021 with around £10 million in cash reserves, which should provide a runway “beyond initial MED3000 launches expected over the next year and expected US regulatory approval in 2023.”

https://pharmaphorum.com/news/futura-eyes-fda-filing-as-topical-ed-drug-passes-phase-3-test/

Veeva Plummets As A Key Issue Shadows Its Quarterly Beat

 Medical software maker Veeva Systems (VEEV) issued light sales guidance for the current quarter and full year late Wednesday, leading VEEV stock to plummet.

The outlook disappointment comes on the heels on a July-quarter beat.

"We are very confident in our competitive position and we are performing well financially as we track ahead of our 2025 targets," Chief Financial Officer Brent Bowman said in a written statement.

But in after-hours trading on the stock market today, VEEV stock tumbled 8.2% near 183.

VEEV Stock Skids Despite Quarterly Growth

Adjusted Veeva earnings climbed almost 10% to $1.03 per share during the quarter ended July 31. That beat expectations by two pennies, according to FactSet. Revenue also jumped more than 17% to $534.2 million and beat VEEV stock analysts' forecast for $531 million.

The sales increase lined up with Veeva's subscription services. Revenue in that division advanced 17% year over year to $366.4 million.

For the current quarter, Veeva expects to earn $1.07-$1.08 per share. The earnings guidance was in line with calls for $1.08. But sales guidance was lackluster. Veeva called for $545 million to $547 million in sales. Even the high end of the outlook missed forecasts for $558 million.

Veeva also guided to adjusted income of $4.17 per share on $2.14 billion to $2.145 billion in full-year sales. While the earnings outlook was slightly ahead of expectations for $4.15 a share, Veeva's revenue view was well below VEEV stock analysts' projections for $2.17 billion in sales.

https://www.investors.com/news/technology/veev-stock-veeva-earnings-q2-2023/