NIH starts trial of Pear, Chess apps for opioid use disorder

 Patient recruitment has begun in a National Institutes of Health (NIH) trial of two digital therapeutics (DTx) for people with opioid use disorder (OUD), developed by Pear Therapeutics and Chess Health. 

The CTN-0100 study is test strategies to help keep people with OUD on drug treatment, improve the chances that those stabilised with drug treatments for OUD can come off medication without relapsing, as well as to find ways to predict the risk of relapse based on patient characteristics.

The study is testing various drug regimens along with Pear’s prescription app reSET-O and Chess Health’s free Connections app, given on top of standard medical management for OUD.

The digital apps are based on cognitive behavioural therapy (CBT) and are intended to be used alongside standard treatment for OUD – including pharmacological therapy with drugs like buprenorphine – to reduce opioid use and boost retention with treatment.

In CTN-0100, reSET-O and Connections will be given alongside either Indivior’s Suboxone (transmucosal buprenorphine), Braeburn/Camurus’ Brixadi (injectable buprenorphine), or Alkermes’ Vivitrol (injectable naltrexone), according to the study protocol.

Final results are not due until 2026, according to the entry for the trial on the clinicaltrials.gov database, although interim results may be available sooner.

The trial is part of the NIH Heal initiative, which was launched in 2018 to fund scientific approaches to solving the US opioid overdose crisis, including improved treatment strategies for pain as well as OUD. In 2019, the NIH allocated $945 million in funding for the scheme.

Both reSET-O and Connections were included in an assessment by the influential Institute for Clinical and Economic Review (ICER), which concluded that neither of the apps – or another DTx from DynamiCare Health – have data from a randomised clinical trial showing they can enhance long-term abstinence or retention rates.

Of the three, ICER was able to develop a cost-effectiveness model only for reSET-O, which was approved by the FDA in 2018, as there wasn’t enough clinical data on the other two to make an assessment.

From 1999–2019, nearly 500,000 people died from an overdose involving any opioid, including prescription and illicit opioids, according to the latest figures from the US Centre for Disease Control and Prevention (CDC).

In 2019, more than 70% of the 70,630 deaths recorded in that year involved an opioid.

https://pharmaphorum.com/news/nih-starts-trial-of-pear-chess-apps-for-opioid-use-disorder/

Altimmune looks to obesity as Covid-19 vaccine crashes

 The failure of Altimmune’s nasal Covid-19 vaccine project wiped 16% from the company’s value in early trade today, effectively erasing the gains the stock made on an early hit in obesity – with a different project – a fortnight ago. The extent of investors’ expectations for the AdCOVID vaccine is surprising given that Altimmmune had taken 16 months to generate phase 1 data and had secured no major partner. Plenty of other small-cap biotechs also have Covid vaccine candidates in early and mid-stage trials, as the table below shows, and might be at similar risk of losing value should their projects also disappoint. Those with data looming include Vaxart and Arcturus Therapeutics. As for Altimmune, attention will now turn to the full 12-week data from the obesity study that showed such promise at the halfway point. If the final data remain solid – or actually improve, given that ALT-801 is to be dosed at higher levels – this could be Altimmune’s chance to hook a partner, and help investors forget their Covid-19 vaccine disappointment.

Selected early and mid-stage Covid-19 vaccine candidates
Vaccine	Company	Market cap ($m)	Notes
Phase 1
AdCOVID	Altimmune	626	Ph1 failed Jun 21; project discontinued
ChAdV68-S-TCE	Gritstone Bio	478	Topline ph1 data expected mid-year
CORVax12	Oncosec Medical	124	Ph1 data poss Q3'21
CoVepiT	OSE Immunotherapeutics	256	Ph1 data poss Q4'21
VXA-CoV2-1	Vaxart	1,067	Oral vaccine. Topline Ph1 data released in Feb 21, Ph2 trials planned
Phase 2
ABNCoV2	ExpreS2ion Biotech Holding/Bavarian Nordic	135/2,721	Topline data from Cough-1 trial expected Jul 21
ARCT-021	Arcturus Therapeutics/ Recipharm	930/2,809	Ph2 data imminent. Ph3 trial expected Q3'21; EUA poss H2'21
hAd5-Covid-S/N	ImmunityBio	5,843	SC, oral and sublingual formulations being tested; early safety data reported and several trials ongoing
VBI-2902a	VBI Vaccines	1,019	Ph1/2 data expected Q2'21
Source: Evaluate Pharma, clinicaltrials.gov and company websites. https://www.evaluate.com/vantage/articles/news/snippets/altimmune-looks-obesity-covid-19-vaccine-crashes

Ocuphire sees more success for Nyxol

 Ocuphire is on a winning streak. The ophthalmology company today reported positive results in the phase 2 Vega-1 trial for its lead product Nyxol in presbyopia. In the 150 patient study 61% of patients treated with Nyxol in combination with low-dose pilocarpine (LDP) showed a 15 letter improvement in their near vision after one hour compared with 28% of those in the placebo group. Presbyopia is the gradual age-related loss of the eyes’ ability to focus on nearby objects and is usually corrected with reading glasses or contact lenses. Ocuphire is hoping to offer the first pharmacological approach to the problem. However, the key question is whether the current six hour duration of treatment Nyxol provides will be enough to overcome the relative inconvenience of wearing glasses. This is the second piece of good news for Ocuphire, following a previous win in the phase 3 Mira-2 trial. In that study Nyxol hit its primary end point in correcting pharmacologically induced mydriasis – the medical dilation of pupils during eye exams. This second win sent shares in Ocuphire, which reversed into Rexahn Pharmaceuticals late last year, up 20%. A third phase 3 is due to report at the end of Q3, trialling Nyxol in night vision disturbances.

https://www.evaluate.com/vantage/articles/news/snippets/ocuphire-sees-more-success-nyxol

Hims & Hers Partners with Urban Outfitters on Personalized Health and Wellness Solutions

 Hims & Hers Health, Inc. ("Hims & Hers", NYSE: HIMS), the multi-specialty telehealth platform focused on providing modern personalized health and wellness experiences to consumers, today announced a partnership with Urban Outfitters, Inc. (NASDAQ:URBN), a leading lifestyle products and services company that is dedicated to inspiring their customers through a unique combination of product, creativity and cultural understanding — which will offer personalized health and wellness solutions, starting with the availability of select Hims products, on urbanoutfitters.com.

"Our priority has, and will always be, the consumer," said Melissa Baird, Chief Operating Officer of Hims & Hers. "At Hims & Hers, we’re trying to provide everyone with access to gorgeously designed, high quality, personalized, and affordable products that benefit their health and wellness. Being able to expand our product reach to consumers through a partnership with such an iconic and inspirational lifestyle brand is incredibly exciting for us. We are truly honored to partner with Urban Outfitters and make Hims & Hers’ solutions available to their digitally native and diverse audience via urbanoutfitters.com."

Hims & Hers and Urban Outfitters plan to expand the offering in the coming months by introducing select Hers products and offering more Hims solutions on UrbanOutfitters.com. The planned offering will include options for consumers seeking solutions for skin care and hair loss, sexual health and wellness, supplements, and other personal care items. The Blur Stick Concealer for Men, recently launched by Hims, will be Urban Outfitters first foray into men’s makeup.

"Digitally native consumers who visit Urban Outfitters are looking for the most personalized experiences that help them express their authentic selves," said Jena Tracey, Executive Director of Merchandising for Urban Outfitters. "There is great synergy between the Urban Outfitters customer and those digitally native consumers who are interested in the personalized health and wellness offerings of Hims & Hers, and we are thrilled to be offering such beautiful and high quality products to people on our site."

https://finance.yahoo.com/news/hims-hers-partners-urban-outfitters-125700550.html

Fed is in early stages of campaign to prepare markets for tapering

 The Federal Reserve is in the early stages of a campaign to ready markets for reducing its $120 billion in monthly asset purchases to stimulate the economy.

Comments by Fed officials in the past several weeks suggest the issue of tapering looks likely to be discussed as soon as the Federal Open Markets Committee meeting next week, and the Fed may be on track to begin asset reductions later this year or early next year.

At least five Fed officials have publicly commented on the likelihood of those discussions in recent weeks, including Patrick Harker, president of the of the Federal Reserve Bank of Philadelphia, Robert Kaplan of Dallas, Fed Vice Chair for bank supervision Randal Quarles and Cleveland Fed President Loretta Mester, whose comments to CNBC came after Friday’s monthly jobs report.

“As the economy continues to improve, and we see it in the data, and we get closer to our goals … we’re going to have discussions about our stance of policy overall, including our asset purchase programs and including our interest rates,” Mester said Friday.

While the discussion may take place, an announcement of a decision to actually taper would be several months later, perhaps in late summer or early fall. That announcement would then put the beginning of the asset reduction further out, perhaps by year-end or early next year. Since the Fed will taper its purchases, that is, reduce the amount it buys by some amount each month, that timeline would still see the Fed purchasing billions of dollars of assets well into 2022, though at an increasingly slower pace.

All of that is contingent on how the economy rebounds from the pandemic. The recent pace of new job growth, averaging 541,000 payrolls over the past three months, and the recent decline in the unemployment rate look to be more or less in line with Fed expectations. Most Fed officials continue to believe that the recent spurt of inflation will prove temporary, so even big monthly gains are unlikely to speed up the plan, at least for a time.

Avoiding a tantrum

While the decision to taper is based on economic data, it eventually will be converted by Fed officials to calendar dates, though, as the Fed has done in the past, still linked to the data.

Behind the glacial pace of reducing asset purchases is a deliberate attempt to avoid another so-called taper tantrum, the sharp spike in bond yields in 2013 that came after Fed Chairman Ben Bernanke hinted asset purchases could wind down.

One view inside the Fed is that the taper tantrum occurred because it failed to adequately separate in the market’s mind the timelines for hiking interest rates and for reducing asset purchases. This time, the Fed is creating a long runway for tapering, making clear that rate increases only come after this process. It also has set a higher standard of economic improvement required for rate increases than it has for asset purchase reductions.

Quarles late last month made that separation clear, saying: “It will become important for the FOMC to begin discussing our plans to adjust the pace of asset purchases at upcoming meetings.” But, he added,  “in contrast, the time for discussing a change in the federal funds rate remains far in the future.”

At the moment, fixed income markets appear to be giving the Fed leeway to follow a gradual timeline. The 10-year note yield has been anchored around 1.60 percent for nearly four months, and the 2-year note rate has hovered around 15 basis points (0.15%). Fed Funds futures do not fully price in a 25-basis point rate hike from the Fed until early 2023.

Fed officials expected volatility around any announcement that it will reduce asset purchases. And it’s clear yields could rise as a result. It’s possible markets may become more aggressive in pricing in rate hikes. The measure of success for the Fed’s current efforts will come if policymakers can move toward reducing asset purchases but see only modest changes in expectations for rate increases.

The key risk now is that the Fed, in trying to avoid a taper tantrum, maintains easy monetary policy too long, allowing inflation to become a permanent, rather than temporary, problem.

https://www.cnbc.com/2021/06/07/the-fed-is-in-the-early-stages-of-a-campaign-to-prepare-markets-for-tapering-its-asset-purchases.html

Aerovate Therapeutics Prices Upsized IPO

 Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the pricing of its upsized initial public offering of 8,682,142 shares of common stock at a public offering price of $14.00 per share, before underwriting discounts and commissions. In addition, Aerovate has granted the underwriters a 30-day option to purchase up to an additional 1,302,321 shares of common stock at the initial public offering price per share, less the underwriting discounts and commissions. All of the shares are being offered by Aerovate. The gross proceeds of the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Aerovate, are expected to be approximately $121.5 million, excluding any exercise of the underwriters’ option to purchase additional shares.

The shares are expected to begin trading on the Nasdaq Global Market on June 30, 2021 under the ticker symbol “AVTE.” The offering is expected to close on July 2, 2021, subject to the satisfaction of customary closing conditions.

Jefferies LLC, Cowen and Company LLC, and Evercore Group L.L.C. are acting as joint book-running managers for the offering. Wedbush Securities Inc. is acting as a lead manager for the proposed offering.

https://www.globenewswire.com/news-release/2021/06/30/2255267/0/en/Aerovate-Therapeutics-Announces-Pricing-of-Upsized-Initial-Public-Offering.html

What's Going On With Ocugen

 Ocugen Inc 

OCGN 2.14% shares are trading 1.6% higher in the pre-market session on Wednesday amid high social media interest.

The company's shares had closed nearly 2% lower at $8.46 in the regular session, the day prior.

Ocugen is the top-trending stock on Stocktwits at press time and also seeing high interest on Reddit and Twitter.

The company entered into a definitive agreement in February with India’s Bharat Biotech to co-develop, supply, and commercialize the latter’s Covaxin whole-virion inactivated COVID-19 vaccine in the United States.

Brazil's government announced Wednesday it was suspending the contract to purchase 20 million Covaxin doses in the aftermath of allegations of corruption in the deal, Indian daily The News Minute reported.

The Ocugen partner had earlier in the day said that it had secured emergency use authorizations in over 16 countries including Brazil, India, and Mexico, as per Indian news agency ANI, and another 50 EUAs were in process globally.

Brazil was to be supplied the Covaxin vaccine at $5 per dose under the agreement. Covaxin pricing is otherwise set between $15 to $20 per dose for supplies to governments other than India.

Bharat Biotech had said "step-by-step approach" was followed "towards contracts, &regulatory approvals, during 8-month-long process" in securing the deal with Brazil, adding — as of Tuesday — it hadn't "received any advance payments nor supplied vaccines to Brazil."

https://www.benzinga.com/general/biotech/21/06/21780714/whats-going-on-with-ocugen-ocgn-stock-today