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Thursday, July 18, 2019

InflaRx up after hours on additional Phase 2b data

InflaRx (NASDAQ:IFRX) is up 6% after hours on the heels of additional datafrom its Phase 2b clinical trial, SHINE, evaluating IFX-1 in patients with moderate-to-severe hidradenitis suppurativa, a painful inflammatory skin disorder.
The company says results from the high-dose group showed “multiple efficacy signals” that support continued development. Specifically, there was a statistically significant reduction in draining fistulas compared to placebo in this cohort.
The open-label extension part of SHINE is ongoing. The last patient should be dosed by the end of next month. Additional data will be analyzed when available. IFRX plans to meet with the FDA after SHINE is completed to discuss a potential registration path.
In early June, shares collapsed 92% when the company reported topline results that failed to sufficiently separate from control.
Management will host a conference call tomorrow, July 19, at 8:00 am ET to discuss the data.

Select Medical sees Q2 top line as high as ~$1.4B

Related to its talks with lenders about refinancing its existing debt, Select Medical Holdings (NYSE:SEM) announces certain estimates of Q2 results.
Net operating revenue: $1.360B – 1.362B.
Non-GAAP EBITDA: $185.5M – 187.0M.
It will report final Q2 results and updated guidance on Friday, August 2, before the open.

Medical Marijuana Won’t Help Ease Opioid Crisis: Columbia Study

Some proponents of medical marijuana have claimed that its use against pain might help curb the ongoing crisis of opioid abuse.
But a new study refutes that notion, finding that state laws legalizing medical marijuana have had little impact on the issue.
“When comparing the overall effect of use after versus before medical marijuana laws were passed, we found small increases in nonmedical use of prescription opioids and slight decreases or no change in prescription opioid use disorder among nonmedical users of prescription opioids — even for states that allowed dispensaries,” said study first author Dr. Luis Segura. He’s a doctoral student in epidemiology at Columbia University Mailman School of Public Health, in New York City.
For the study, the researchers analyzed data from the National Survey on Drug Use and Health from 2004 to 2014. They looked at potential connections between individual prescription opioid use and opioid addiction and living in a state where medical marijuana is legal. The survey included about 70,000 people, aged 12 and older.
The study was published online July 17 in JAMA Network Open.
Some — but not all — prior studies on this issue found that opioid prescribing, prescription opioid abuse and opioid overdoses fell after medical pot became legal.
“The hypothesis generated from these studies is that after medical marijuana law enactment, health care professionals would be more likely to prescribe medical marijuana instead of opioid medications, and this in turn would reduce the chance of individuals to misuse prescription opioids and develop consequences,” explained study senior author Dr. Silvia Martins, an associate professor of epidemiology.
However, “we tested this relationship and found no evidence that the passage of medical marijuana laws — even in states with dispensaries — was associated with a decrease in individual opioid use of prescription opioids for nonmedical purposes,” she added.
So, relying on moves such as the legalization of medical marijuana to curb opioid use may simply not be enough, Martins said. Instead, outreach targeted specifically at opioid users, “such as prescription drug-monitoring programs and laws on prescribing practices — are needed,” she believes.
The Columbia findings mirror those from a study published June 10 in the Proceedings of the National Academy of Sciences, which was led by Chelsea Shover, a postdoctoral researcher at Stanford University.
Her team compared opioid abuse cases in states that did or did not legalize medical marijuana and found no association between medical marijuana laws and opioid overdose death rates.
In fact, the overdose death rate actually increased between 1999 and 2017 in states that legalized medical pot, rising by about 23%, according to the Stanford study.

Chinese Scientists Cut Local Numbers of Dangerous Mosquito by 94%

Some mosquitoes spread diseases to humans through their bite, passing along harmful pathogens like Zika, dengue fever, West Nile virus and chikungunya.
Now humans are turning the tables, infecting these dangerous mosquitoes with bacteria that sabotage their ability to spawn.
Chinese researchers were able to reduce these mosquito populations by as much as 94% using a bacteria-based strategy that interferes with the insects’ reproductive cycle.
“In principle, all the mosquito-borne diseases, including dengue, malaria, West Nile, chikungunya and filariasis, can be controlled using this technology,” said senior study author Zhiyong Xi. He is director of the Sun Yat-sen University/Michigan State University Joint Center of Vector Control for Tropical Diseases. “There will be none of those diseases without transmission by mosquitoes.”
The mosquito control strategy hinges on bacteria called Wolbachia, which can affect the reproductive biology of mosquitoes, said Peter Armbruster, a professor of biology at Georgetown University, in Washington, D.C.
Essentially, a male mosquito carrying a specific strain of Wolbachia cannot successfully reproduce if the female is infected with a different strain of Wolbachia, explained Armbruster, who wrote an editorial accompanying the report in the July 17 issue of the journal Nature.
The Chinese research team created a lab-based colony of mosquitoes that all carry a newly developed combination of three Wolbachia strains. This hybrid strain doesn’t occur in the wild. The colony produced around 10 million male mosquitoes a week, Xi said.
The male mosquitoes were then released into the wild, in areas designated for pest control.
“They mate with wild females and then the wild females produce inviable eggs,” Armbruster said. “It’s a way of letting the males do the work by finding the females and preventing them from reproducing.”
The researchers also treated the mosquitoes with a low dose of radiation, enough to sterilize any accidentally released females carrying the triple bacteria strain but not enough to impair the male mosquitoes’ reproductive drive. This helped speed up laboratory production of the mosquitoes, Armbruster explained.
Field trials focused on Aedes albopictus mosquitoes were able to drive populations down by around 83% to 94%, with no wild mosquitoes detected for up to six weeks after release, the researchers reported.
Dr. Amesh Adalja is senior scholar at the Johns Hopkins Center for Health Security in Baltimore. “Mosquitoes have long been a scourge of mankind and their effective control is one of the most daunting tasks in infectious diseases,” he said.
“Exploiting the phenomenon of mating incompatibility through male mosquito Wolbachiainfections, combined with irradiation, is an elegant solution that this study demonstrates is feasible,” Adalja said.
At least one American company, MosquitoMate, is already using a similar bacteria-based approach to control mosquitoes, Armbruster noted. The innovation in the study was the combination of three different Wolbachia strains and the use of radiation to make sorting and releasing mosquitoes an easier process.
You don’t want to release both male and female mosquitoes with the triple strain, because they’ll be able to successfully mate. Until now, lab technicians have had to run the mosquito swarms through a machine that separated males from females, and then do a second hand-sort to make sure all the females had been removed, Armbruster said.
Because the approach targets specific disease-carrying species of mosquitoes, it will not wipe out other benign mosquito populations that co-exist in the same area, Xi added.
“As mating happens only within the same species, this is a species-specific control tool, without any impact on non-target species,” Xi said. “The majority of mosquito species in nature are not disease vectors, and thus will not be targeted by our technique.”
These field tests released the lab-infected male mosquitoes on two small islands located on rivers that run through Guangzhou, the city with the highest dengue transmission rate in China, the study authors said.
The goal was to reach a 5-to-1 ratio of infected males versus wild males, to effectively suppress the mosquito populations, Xi said.
Further research will be needed to see if the same laboratory production techniques could be used to battle mosquitoes in large U.S. cities, Armbruster said.
“It’s still an open question whether this is scalable to a major metropolitan area,” Armbruster said.
More information
The U.S. Centers for Disease Control and Prevention has more about mosquito control.
SOURCES: Zhiyong Xi, Ph.D., professor, microbiology and molecular genetics, and director, Sun Yat-sen University/Michigan State University Joint Center of Vector Control for Tropical Diseases; Peter Armbruster, Ph.D., professor, biology, Georgetown University, Washington, D.C.; Amesh Adalja, M.D., snior scholar, Johns Hopkins Center for Health Security, Baltimore; July 17, 2019, Nature

Boehringer picks up Bridge Bio pulmonary fibrosis med for $50M

Nearly five years after lung-scarring med Ofev got the FDA nod, its maker wants to get cracking on a  successor. Boehringer Ingelheim is licensing an autotaxin inhibitor from Bridge Biotherapeutics for €45 million ($50 million) upfront.
Seongnam, South Korea-based Bridge Biotherapeutics is developing the compound, BBT-877, for fibrosing interstitial lung diseases, in which scarring affects a group of support tissues in the lungs. It’s currently in phase 1 studies and slated to enter phase 2 in the next year.
Under the deal, Boehringer and BridgeBio will develop BBT-877 for idiopathic pulmonary fibrosis (IPF), a rare and fatal disease in which progressive scarring in the lungs makes breathing difficult and prevents the lungs from delivering enough oxygen to the rest of the body. Some patients may receive a lung transplant, but others are too frail for the procedure. Other treatments, such as supplemental oxygen and pulmonary rehabilitation, focus on managing symptoms.
There are only two FDA-approved IPF drugs—Boehringer’s Ofev and Genentech’s Esbriet. Both work by delaying disease progression, but they do not cure it.
BBT-877 blocks autotaxin, an enzyme that plays a role in promoting scarring in multiple cell types. It has shown promise in preclinical models of fibrosing interstitial lung diseases—in which scarring affects a group of support tissues in the lungs—and could potentially be combined with other treatments.
“We look forward to working with the team at Bridge Biotherapeutics to develop a new treatment option for patients with IPF. This new collaboration complements our growing pipeline in fibrosing interstitial lung diseases and is a sign of our determination to bring the next generation of treatment options to these patients,” said Michel Pairet, who sits on Boehringer’s board of managing directors with responsibility for the company’s Innovation Unit, in a statement.
In addition to €45 million in upfront and near-term payments, Bridge Biotherapeutics could end up netting more than €1.1 billion in total if it meets all of its milestones.
This isn’t Boehringer’s first IPF deal post-Ofev. In 2016, it inked an R&D pact with France’s Inventiva Pharma under which it paid €170 million ($190 million) in return for a chance to tap into transcriptional regulation and fibrosis tools and know-how Inventiva originally picked up in a deal with Abbott. A year later, Boehringer pulled the trigger on an option to jointly discover new drugs against a new, validated IPF target.

Becton Dickinson recalls infusion sets on safety issue

Becton, Dickinson and Company (BDX +0.7%) is recalling its Alaris Pump Model 1800 Infusion Sets that were made between May 1, 2016 and April 18, 2019 due to the potential for faster-than-expected delivery of medication or an unintended delivery when the pump is not running. The problem is apparently due to non-uniform thickness of the silicon segment of the set which can lead to non-uniform tubing collapse and incomplete occlusion.

Intuitive Q2 system sales up 39%; non-GAAP earnings up 25%

Intuitive (NASDAQ:ISRGQ2 results ($M): Revenues: 1,098.9 (+12.9%); Instruments & accessories: 578.5 (+4.7%); Systems: 343.8 (+38.9%); Services: 176.6 (+1.6%).
Net income: 316.4 (+4.1%); non-GAAP net income: 318.3(+24.7%); EPS: 2.67 (+4.3%); non-GAAP EPS: 3.25 (+17.8%).
Global da Vinci procedures up ~17%.
Shipments of da Vinci systems up 24% to 273.
Installed base: 5,270 (+12.9%).
Shares are down 2% after hours.