Precigen ActoBio’s diabetes drug shows encouraging effect in early-stage study

Precigen’s (PGEN +0.8%) subsidiary Precigen ActoBio, has announced that its Phase 1b monotherapy portion of the ongoing Phase 1b/2a AG019 trial, has met the primary endpoint for the treatment of early-onset type 1 diabetes.

The study demonstrated safety and tolerability, with no safety signals were observed, and no patient discontinued treatment.

Eight-week treatment with AG019 monotherapy was safe and well-tolerated in daily dosages up to 6 x 10¹¹ CFU (colony-forming units) in adult and adolescent patients.

Preliminary results demonstrated slower decline in C-peptide levels (biomarker for T1D disease progression) in 67% of adult patients in AG019 arm with 44% of these adult patients showing stabilization of mean four hours C-peptide area under the curve levels at six month

Phase 2a portion of the study is investigating safety and tolerability of AG019 in combination with teplizumab (PRV-031).

https://seekingalpha.com/news/3603443-precigen-actobios-diabetes-drug-shows-encouraging-effect-in-early-stage-study

GigaGen’s polyclonal antibody against COVID-19 outperforms plasma in lab tests

Blood collected from survivors of COVID-19 has been used to identify antibodies against the disease, which have been turned into experimental drugs to fight it. But it’s not an easy process. So back in March, San Francisco startup GigaGen decided to test a technology it developed to rapidly identify disease-fighting antibodies against SARS-CoV-2, the virus at the heart of the pandemic, and turn them into a drug to fight the disease.

Now the company says it has early evidence that the approach has yielded a promising drug candidate, GIGA-2050. When tested against the SARS-CoV-2 live virus, GIGA-2050 was 100 times more protective than plasma from survivors, they reported on the journal preprint site bioRxiv.

In March, the GigaGen team took plasma from 50 people in Louisiana who had either tested positive for COVID-19 or shown symptoms of the disease. They selected 16 samples with high levels of disease-fighting antibodies, and from there built 8 libraries, each of which contained between 54,986 and 156,592 different antibodies, according to the study (PDF).

After screening the libraries, the researchers created GIGA-2050, which GigaGen refers to as a recombinant anti-coronavirus 19 hyperimmune gammaglobulin (rCIG). The drug candidate comprises 12,500 of the most potent COVID-19 antibodies. In addition to showing activity against SARS-CoV-2, the compound also bound to variants of the coronavirus, including SARS-CoV, which caused an outbreak in the early 2000s, GigaGen reported.

“We completed this entire process, from delivery of the first donor sample to lab-scale generation of the rCIG protein product, in less than three months,” the researchers wrote in the study.

GigaGen expects to start clinical trials of GIGA-2050 in COVID-19 patients early next year.

GigaGen was founded in 2010 and is developing antibody treatments for cancer, primary immune deficiency and other diseases. It has a partnership with Spain-based Grifols to discover new treatments for infectious diseases. In July, Grifols invested $35 million for a 44% stake in GigaGen, plus $15 million for a licensing deal (PDF).

GigaGen will have plenty of competition in the COVID-19 antibody race, most notably from Regeneron, which is already in human trials of a cocktail of anti-COVID antibodies for both treating and preventing the disease. Other companies in the antibody race include Amgen, AstraZeneca, GlaxoSmithKline and Eli Lilly.

GigaGen CEO David Johnson, Ph.D., said in March he believed the company’s approach would prove to be highly scalable and would yield polyclonal therapies that “are consistent from batch to batch, enabling a controlled dosing protocol.”

That said, GigaGen’s scientists are concerned that the public health system is unprepared to support the advanced technologies that have been born during this pandemic. “Though we demonstrated that our technology could be used to generate a pandemic response very quickly, there needs to be further investment by public health authorities to build out emergency GMP production facilities to quickly generate clinical material during a pandemic,” the authors wrote.

https://www.fiercebiotech.com/research/gigagen-s-polyclonal-antibody-against-covid-19-outperforms-plasma-lab-tests

Hoth shoots up on securing the rights for breath-based COVID-19 test device

Hoth Therapeutics (NASDAQ:HOTH) jumps 25% premarket on its announcement of licensing IP rights to develop a real-time mobile testing device that has the potential to immediately diagnose COVID-19 infection through breath sample.

The device, the design of which is developed by GW, is based on nanotechnology nanoholes using plasmonics principles that allow the virus to bind to the surface, thereby allowing for the detection of an optical change that could immediately be sensed by phone cameras when an infected person’s specimen is applied.

“Securing the rights to this paradigm shifting technology in the fight against the global COVID-19 pandemic is a significant opportunity for Hoth and its shareholders,” says CEO Robb Knie.

https://seekingalpha.com/news/3603404-hoth-therapeutics-shoots-up-on-securing-rights-for-breath-based-covidminus-19-testing-device

Reata down on potential block to omaveloxolone in genetic disorder

Despite its Q2 beat, Reata Pharmaceuticals (RETA -31.7%) is down out the gate on the heels of its update on omaveloxolone for Friedreich’s Ataxia (FA), a rare genetic disease that causes difficulty walking, a loss of sensation in the arms and legs, and impaired speech.

There is a risk that the filing of a U.S. marketing application will be delayed indefinitely if the FDA requires an additional pivotal study due to the limited availability of FA patients.

In October 2019, the company announced positive results from Part 2 of the Phase 2 MOXIe study. The FDA, however, appears unconvinced that the data are sufficient to support approval.

Considering the long timeline associated with conducting another pivotal trial, the company has proposed a crossover study as a compromise. It would measure the effect of omaveloxolone in patients in the control arm of MOXIe who are receiving the med in the open-label extension.

If the agency signs off on its proposal, RETA expects to complete the crossover study as early as Q4 with an NDA to follow in Q1 2021.

If the FDA rejects the proposal or if the data are not supportive, it will evaluate whether it is feasible to conduct a second pivotal study. In other words, development may stop.

https://seekingalpha.com/news/3603396-reata-pharma-down-32-on-potential-roadblock-on-omaveloxolone-in-rare-neurodegenerative

FDA signs off on late-stage study of Seelos’s ALS candidate

The FDA has OK’d the initiation of Seelos Therapeutics’s (SEEL +5.5%) Phase 2b/3 trial for SLS-005 (trehalose), for the treatment of Amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).

The trial will enroll 160 patients, with primary endpoint measuring change from baseline on revised ALS functional rating scale score at 24 weeks.

Secondary endpoints will also be measured at 24 weeks, including change from baseline in slow vital capacity, muscle strength, quality of life measurements as well as additional signs of disease progression.

ALS is a rare neurological disease that mainly involve the nerve cells responsible for controlling voluntary muscle movement.

https://seekingalpha.com/news/3603427-fda-signs-off-on-late-stage-study-of-seeloss-als-candidate-slsminus-005

Novo Nordisk, unscathed by Covid, in ‘strike mode’ with diabetes launch Rybelsus

Novo Nordisk scored approval last September for what it heralded as a “holy grail” diabetes medicine in Rybelsus, but it was waiting to deploy its full launch effort until securing access through payer negotiations.

That time has come. Novo has negotiated 70% combined access for the medicine in the U.S., CEO Lars Fruergaard Jørgensen said on a conference call Thursday, and it’s now in “strike mode.” Novo’s sales reps are back in the field in the U.S. amid the COVID-19 pandemic, but they aren’t back up to full steam in terms of scheduling meetings. Those are running at about 80% of a full schedule before the pandemic, including some video and phone calls, Jørgensen said in an interview.

Throughout the pandemic, physicians have become “increasingly receptive” to video and phone interactions, the CEO said. While launching during a pandemic is clearly tougher, he said the company is “very pleased” with uptake so far.

The Rybelsus ramp-up comes as Novo’s injectable version of the medicine, Ozempic, continues its ascent. In the first half, the med surpassed older GLP-1 diabetes drug Victoza to become the company’s bestselling medicine two and a half years after its U.S. rollout. Ozempic sales grew 152% to $1.5 billion in the first half of 2020, while Victoza sales slipped 18% to $1.47 billion.

The newer Rybelsus generated $92 million, beating analyst expectations. Looking forward, Novo aims to “repeat what we did with Ozempic,” Jørgensen said, which he said was “among the best launches ever in diabetes.”

Overall, Novo’s GLP-1 sales grew 28% at constant exchange rates to more than $3 billion during the first half. COVID-related stocking boosted sales, but patient starts decreased and mostly offset that benefit. Jørgensen said he expects some “normalization” of patient starts during the second half of the year.

It wasn’t all good news for the drugmaker, though. Global insulin sales fell 3% at constant exchange rates, dragged down by a 23% decline in North America. Lower prices, higher rebates, new affordability programs and other factors hurt insulin revenues. Novo saw an insulin stocking boost due to the pandemic, but like with other medicines, fewer patients started treatment, in turn hurting sales.

First-half savings from the pandemic amounted to 1 billion Danish kroner, CFO Karsten Munk Knudsen said on the conference call, or about $160 million. Some of that total will be funneled into future launches, and some is expected to become permanent savings, such as money that would have been spent on airline travel. Airplane ticket spending was down 90% in the second quarter, Knudsen said.

https://www.fiercepharma.com/pharma/after-access-talks-novo-nordisk-shifts-into-gear-for-rybelsus-launch

Eagle Pharmaceuticals EPS beats by $0.34, misses on revenue August 10, 2020

Eagle Pharmaceuticals (NASDAQ:EGRX): Q2 Non-GAAP EPS of $0.57 beats by $0.34; GAAP EPS of -$0.02 beats by $0.30.

Revenue of $41.94M (-26.0% Y/Y) misses by $0.29M.

Press Release

https://seekingalpha.com/news/3603220-eagle-pharmaceuticals-eps-beats-0_34-misses-on-revenue