Diffusion Pharma changes design of early-stage study of TSC in COVID-19

The FDA has suggested certain study design changes related to endpoints and statistical considerations, for Diffusion Pharmaceuticals’s (DFFN -12.5%) trans sodium crocetinate (TSC) in COVID-19 patients.

The Company now expects to enroll the first patient by the end of August, vs. end of July as expected earlier, with first data available in the early next quarter.

IND for the trial was filed earlier this month.

https://seekingalpha.com/news/3595249-diffusion-pharma-changes-design-of-early-stage-study-of-tsc-in-covidminus-19

All You Need to Know About Health Start-up Hims

At some point in their lives, nearly 50% of men will experience hair loss due to stress, genetics, or hormone imbalance. Up to 40% of males over age 40 experience erectile dysfunction (ED). These are not insignificant problems and can be signs of deeper medical issues, yet they often go untreated: 60% of men report that they don’t go to a doctor until they have symptoms that are too painful or acute to ignore.

There’s an obvious need for a men’s wellness service that’s accessible, efficient, and discreet. Fortunately, there’s a start-up in this niche with overwhelmingly positive reviews. Let’s dig into the future of this start-up. Could it have an initial public offering (IPO) or be acquired in the next few years?

A disruptor in men’s wellness treatments

The start-up is Hims, an internet pharmacy and telemedicine company that has made its goal to revolutionize men’s wellness. Recently, the company received the endorsement of Snoop Dogg in raising awareness for men with sexual dysfunction.

Hims was founded by Jack Abraham and Andrew Dudum in 2017. The company aims to help men (and women, thanks to a new expansion) save time, money, and the potential embarrassment of a doctor’s appointment by delivering health products to customers’ doorsteps, with no shipping costs.

To sign up, consumers complete a medical profile on the company’s website to get matched with a licensed physician on the Hims platform within minutes. After a consultation, users can proceed with a one-off purchase of a prescription drug, essential vitamin, or wellness product. Alternatively, they can purchase a monthly subscription. Hims offers mostly hair loss, ED, and skincare treatment products.

One of the company’s major competitors is a healthcare start-up called Ro and its telemedicine service Roman. Roman offers a well-rounded, digital health clinic for men where patients can get products for ED, testosterone support, and hair loss treatments. Roman and Hims have similar pricing for their prescription services.

How much does Hims cost?

Hims’ ED treatment offerings consist of various prescription drugs including Viagra and Cialis, which range from $30 to $425 per month for a supply of between five to 30 pills.

The company’s hair loss treatments include generic hair loss drugs, shampoos, and vitamin gummies. These therapeutic options cost up to $33 per month. Hims’ skincare products range from anti-aging creams to moisturizers that can cost up to $49 per month. In addition to the cost of the goods themselves, there’s a $5 consultation fee.

In response to the COVID-19 pandemic, Hims is now offering at-home COVID-19 saliva test kits that are sent to a lab that provides results in three to five days. The test is authorized by the U.S. Food and Drug Administration (FDA) and it costs about $150. Additionally, the company is now offering primary care telemedicine and online therapy sessions on its platform, where one can perform a virtual visit with a physician. At $39 per visit, the service is competitively priced with Teladoc Health‘s (NYSE:TDOC) online consultations.

Lastly, Hims launched an expansion that caters to women in 2018 called Hers. Hers offers women’s wellness products such as acne treatments, birth control, anti-aging cream, and hair products. Like Hims, Hers is competitively priced with prices being 50% to 80% lower than retail prices for certain products. However, unlike Hims, Hers does not currently accept insurance.

Is Hims worth it?

At first glance, many of Hims products may seem very costly. However, they are actually 75% cheaper than what consumers would obtain at an over-the-counter pharmacy, and 50% to 80% cheaper for certain branded wellness products. In addition, patients may be eligible for insurance reimbursement should they be prescribed a generic drug from Hims.

Speaking of generics, many of the company’s products are off-patent versions of reputable branded drugs, with their efficacy and safety validated by the FDA. Furthermore, the company’s medical team is fully licensed.

Will the company IPO soon?

With all its benefits, it should be no surprise Hims is gaining rapid consumer validation in the telemedicine sector. Since 2017, Hims has raised over $197 million from its investors. The company is currently at the series C of funding — the venture capital stage at which a company will commonly decide to IPO or otherwise find an exit in the form of a buyout. Last year, the company brought in over $100 million in revenue, and this year, the company has set staggering revenue guidance of $250 million for 2020.

From its affordable wellness products to the licensed physicians on its platform, Hims is rapidly transforming telemedicine in the male wellness sector. Healthcare investors should definitely keep an eye out for Hims should it move toward an IPO.

Its current $1 billion valuation and unicorn start-up status are already keeping investors hyped up. Indeed, the company is worth more than $500 million than Ro, which is only at the series B stage of funding. With a male dysfunction market opportunity of just $2.9 billion, it seems like an environment favoring a winner-take-all scenario. Of course, Hims and Roman offer more than just ED solutions, so that diversification is a strength.

Could Hims be acquired?

With the company attaining unicorn start-up status in just a couple of years, there are many companies that may be interested in acquiring Hims. Johnson & Johnson(NYSE:JNJ)owns hair loss treatment Rogaine and is in need of significant growth to its revenue. Other consumer goods companies, such as Procter & Gamble, and retail pharmacies like CVS Health and Walgreens Boots Alliance, are all potential acquirers of Hims or its competitors.

Ultimately, Hims is a high-growth telemedicine company that’s rapidly disrupting the consumer health and wellness industry and is a company that IPO savvy investors should look out for in the next few years.

https://www.fool.com/investing/2020/07/25/everything-you-need-to-know-about-health-start-up.aspx

NIH to start ‘flurry’ of large studies of potential Covid-19 treatments

The National Institutes of Health is preparing to launch a “flurry” of large clinical trials to test new approaches to treating Covid-19, according to the agency’s director, hoping to expand what for now remains a limited arsenal of therapies to help people with the disease.

In an interview, NIH Director Francis Collins characterized the studies as “really well-powered, rigorously designed clinical trials.”

Among the trials, he said: studies of antiviral monoclonal antibodies to treat Covid-19 in both hospitalized patients and patients who can be treated at home; studies of drugs to quell overreaction of the immune system that the agency has picked from dozens of approved treatments; and studies of blood thinners in very sick Covid-19 patients to prevent problems caused by blood clots. Those treatment studies will be on top of the work that the NIH is also doing on vaccines, including the Covid-19 vaccine being developed by Moderna Therapeutics.

Currently, only two drugs have been shown to be effective in patients with the disease. In clinical trials, Gilead’s remdesivir reduced the time it took patients to recover; dexamethasone, a steroid, prolonged survival in the sickest patients in a study conducted in the U.K.

Collins, who has been at the NIH for 27 years before becoming director in 2009, said he has become “obsessed” with the agency’s efforts to test medicines as treatments for Covid-19.  He compared the tense and urgent effort to test Covid-19 treatments and vaccines to his time running the Human Genome Project, when there was a heated competition to deliver results before a private-sector project. He said the current effort is far more important.

“Nobody was going to die if we didn’t get the genome project done on a certain day,” Collins said.

Roughly a hundred people across government, academia, and industry have been working to organize large, systematic trials as part of the NIH’s Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) effort. The goal of the public-private partnership is to develop a coordinated approach to prioritizing and speeding development of treatments and vaccines.

Researchers have registered with the U.S. government to begin more than 1,200 Covid-19 studies, according to a STAT analysis. But 38% were small — consisting of fewer than 100 patients. That disorganized effort is unlikely to deliver clear answers about what treatments work and what treatments don’t. Collins said that’s why ACTIV is important. “I think it has been just what was needed to keep us from going down a pathway of continued small studies and chaos about results,” Collins said.

The new trials will be part of that effort. Regeneron Pharmaceuticals, which is developing an anti-Covid-19 antibody cocktail and is participating in an NIH trial on using such antibodies for prevention, will not be included in the antibody treatment trial. But Collins said that other major drug makers would be included. The decision of whether to participate in the studies is entirely up to the manufacturers, and he said that he has no complaints when a company, such as Regeneron or, on vaccines, Pfizer, decides it can move faster on its own.

Collins also warned that the science around both treatments and vaccines is complicated and unpredictable, and requires doing lots of different things with the knowledge that some will fail. But the only solution, he said, is to run many studies in parallel.

Collins said the NIH has aimed not to duplicate efforts being undertaken elsewhere, which is why the U.S. studied remdesivir but not dexamethasone. However, the NIH, the U.K., and the World Health Organization all conducted their own randomized studies of hydroxychloroquine in hospitalized patients; all were negative.

Regardless, Collins promised that the government is going to make sure that trials are conducted rigorously “so that you’re not wasting time, money, or people’s willingness to volunteer.” And he promised that despite the need for speed in vaccine development, there would be no cutting corners.

“We will not put something out, and FDA won’t let us, that is not safe and effective. That’s the bottom line,” Collins said. “Even if we come up empty, I will not tolerate the idea that you put something out that’s actually harmful.”

The NIH is also trying to fix another problem: the need for better, faster Covid-19 tests, through a $1.5 billion effort called the Rapid Acceleration of Diagnostics or RADx initiative,which Collins and his colleagues described in an editorial in the New England Journal of Medicine on Wednesday.

Current testing technology based on the polymerase chain reaction “doesn’t seem to work very well in terms of handling the demand when the demand starts going up higher and higher,” Collins said. RADx has settled on a “Shark Tank”-like format where small startups audition technologies to receive NIH support. Applications have come from 600 efforts, of which 27 have entered the shark tank stage; one is getting ready to begin efforts aimed at manufacturing scale up and clinical validation. Most of these efforts, Collins said, are point-of-care tests.

The goal, he said, is to have an impact soon. Said Collins: “We’re not going to invest in any test that can’t be scaled up to sufficient numbers to have an impact in the coming months.”

NIH to start ‘flurry’ of large studies of potential Covid-19 treatments

Covid vaccines may cause mild side effects, so stress need to educate – experts

While the world awaits the results of large clinical trials of Covid-19 vaccines, experts say the data so far suggest one important possibility: The vaccines may carry a bit of a kick.

In vaccine parlance, they appear to be “reactogenic,” meaning they have induced short-term discomfort in a percentage of the people who have received them in clinical trials. This kind of discomfort includes headache, sore arms, fatigue, chills, and fever.

As long as the side effects of eventual Covid-19 vaccines are transient and not severe, these would not be sources of alarm — in fact, they may be signals of an immune system lurching into gear. It’s a simple fact that some vaccines are more unpleasant to take than others. Think about the pain of a tetanus shot, for instance.

But experts say it makes sense to prepare people now for the possibility that Covid-19 vaccines may be reactogenic.

“I think one of the things we’re going to have to realize is that all of these vaccines are going to be reactogenic…. They’re all going to be associated with reactions,” said Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program in Nashville, Tenn.

“I think if you were to point out that, look, this is going to be a little bit painful, but there’s an end to it, and there’s a greater good to be gained here, I think that that’s probably worthwhile,” agreed Brian Southwell, senior director of the science in the public sphere program at the Center for Communication Science at RTI International, a think tank located in Research Triangle Park, N.C.

At least two manufacturers, Cambridge, Mass.-based Moderna and CanSino, a Chinese vaccine maker, stopped testing the highest doses of their Covid-19 vaccines because of the number of severe adverse events recorded among participants in their clinical trials.

Ian Haydon, one of the volunteers who received the highest dose in the Moderna Phase 1 clinical trial, ended up seeking medical care after he spiked a fever of 103 Fahrenheit 12 hours after getting a second dose of the vaccine. (Most Covid-19 vaccines will likely require two doses to work.)

The side effects are being seen across a number of different vaccines, made in different ways. This does not appear to be a problem linked to a specific type of Covid-19 vaccine.

The Oxford University-AstraZeneca vaccine, which uses a harmless-to-humans virus that infects chimpanzees as its backbone, saw adverse events reported by 60% of recipients in its early phase trial, reported last week in the journal The Lancet. Half of patients who got the highest dose of the Pfizer-BioNTech vaccine — which like Moderna’s is a messenger RNA vaccine — reported side effects.

Even after abandoning study of its highest dose, CanSino saw nearly three-quarters of the people in the vaccine arms in its Phase 2 trial report side effects, though none was severe. The CanSino vaccine uses a human adenovirus as its backbone.

Getting people prepared for the fact that the Covid-19 vaccines may be reactogenic lets them know what to expect when vaccine becomes available, said Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine.

“As with many vaccines, we have found that if we let people know what to expect, then they have fewer concerns if side effects happen,” Neuzil said.

There’s plenty of evidence that people will accept reactogenic vaccines — will virtually rush to get them — if they are concerned enough about the condition the vaccine is designed to prevent.

Edwards said GSK’s shingles vaccine, Shingrix, which reportedly makes people feel pretty miserable for a short period after injection, is a perfect example. Despite the possibility of discomfort, from the moment the vaccine was brought to market, the company could not keep up with the crush of demand for it. (GSK recently announced the vaccine was no longer in short supply.)

Most people know someone who has had shingles; they’ve heard how painful the condition — a reactivation of latent varicella virus, a late side-effect of chickenpox infection — is for people who develop it.

But the behavior of many Americans suggests they don’t see Covid-19 as a particular threat, with many resisting wearing masks and following the social distancing recommendations that have successfully driven down transmission in a number of other parts of the world.

A variety of polls suggest between half and 70% of Americans plan to be vaccinated when Covid-19 vaccines become available, figures that raise concerns in some quarters about the ability of vaccines to trigger herd immunity in the U.S. population.

Noel Brewer, a professor of health behavior at the University of North Carolina, isn’t worried at this point about those polling numbers. At present, it’s not even clear if vaccines will work, he said, which means pollsters are asking people about hypothetical decisions they may have to make at some unknown point in the future.

“It’s all just a bunch of question marks,” said Brewer, who actually thinks the polling numbers look pretty good under the circumstances. “Once folks are faced with a specific vaccine and a particular effectiveness profile and so on, they can then make a decision based on a thing, as opposed to an idea of a thing.”

For most people right now, Covid-19 is invisible “unless you are in an ICU,” he said. “For most of us every day, we don’t see people who are really sick.”

Brewer, who is on a World Health Organization subcommittee on Covid-19 vaccine safety, said people do expect some discomfort from getting vaccinated.

“The real question is: How much discomfort compared to what other things they may be facing? So, if you’re 70 years old and you can’t leave your house at all, you’re going to have one calculus as compared to if you’re someone who’s 20 years old,” he said.

Conditions at the time vaccine becomes ready for use will be a big influencing factor when the public is offered vaccines, said Southwell. In the meantime, though, he thinks it is critical to communicate with the public about issues like how vaccines are made and that the Covid-19 vaccines may be reactogenic.

People are paying attention to these issues, he said, arguing that members of public has a greater capacity to understand than they are generally given credit for.

“There might be a much greater case for acceptance is we do our work in building trust now and laying the groundwork now,” said Southwell. “But we’re not necessarily as focused on that as we could be.”

Covid-19 vaccines may cause mild side effects, experts say, stressing need for education, not alarm

Shanghai Fosun Pharmaceutical: Covid-19 Vaccine in Phase 1 Clinical Trial

Shanghai Fosun Pharmaceutical (Group) Co. said its mRNA vaccine against the coronavirus is still in the initial stage of a phase 1 clinical trial.

The Chinese drug maker shared the progress of its potential vaccine after its Shanghai-listed shares rallied in recent days on reports of its vaccine candidate.

While the National Medical Products Administration has approved the clinical trial of its mRNA Covid-19 vaccine in mainland China, it remains uncertain whether the vaccine will be approved for clinical use, the company said.

In China, vaccines typically require several stages of clinical trials and other certifications before reaching the clinic.

https://www.marketscreener.com/SHANGHAI-FOSUN-PHARMACEUT-6548924/news/Shanghai-Fosun-Pharmaceutical-Says-Covid-19-Vaccine-in-Phase-1-Clinical-Trial-30995386/

Emergent signs $174 million deal to make AstraZeneca’s potential COVID-19 vax

Emergent BioSolutions Inc said on Monday it signed a $174 million (135 million pounds) agreement with AstraZeneca to develop and manufacture the British drugmaker’s COVID-19 vaccine candidate.

AstraZeneca in June picked Emergent to help produce the 300 million doses of its potential COVID-19 vaccine pledged to the United States.

https://www.marketscreener.com/ASTRAZENECA-PLC-4000930/news/Emergent-signs-174-million-deal-to-make-AstraZeneca-s-potential-COVID-19-vaccine-30995522/