Elad Kedar, Orasis CEO (Orasis)

Ora­sis Phar­ma­ceu­ti­cals snags $30M to see its pres­by­opia treat­ment through to PhI­II

Ora­sis Phar­ma­ceu­ti­cals is one of sev­er­al biotechs de­vel­op­ing mi­otic-based eye drops as a po­ten­tial al­ter­na­tive to read­ing glass­es — one drop, and no more squint­ing at text mes­sages. With the help of a $30 mil­lion Se­ries C, the Is­rael-based com­pa­ny has its sights set on Phase III.

“Read­ing glass­es are in­con­ve­nient, they are not aes­thet­i­cal­ly pleas­ing for many peo­ple, and then fi­nal­ly, they are al­so one of the very first signs of ag­ing,” said CEO Elad Kedar, who joined Ora­sis in 2015 short­ly af­ter the com­pa­ny was found­ed.

The pres­by­opia treat­ment works through pupil mod­u­la­tion — con­strict­ing the pupil to cre­ate a “pin­hole ef­fect” and in­crease depth of field, im­prov­ing near vi­sion. The chal­lenge is find­ing the “sweet spot,” Kedar said. Con­strict the pupil too far, and pa­tients could ex­pe­ri­ence near­sight­ed­ness.

Ora­sis will use Se­ries C fund­ing to push its lead can­di­date, CSF-1, in­to Phase III. Two iden­ti­cal tri­als will be con­duct­ed in the US with about 300 par­tic­i­pants each, Kedar said, adding that it’s a ‘mat­ter of weeks” be­fore test­ing be­gins. The com­pa­ny will eval­u­ate the drug for ef­fi­ca­cy, safe­ty and com­fort.

Ora­sis met its pri­ma­ry end­point in a Phase IIb study of CSF-1 with about 160 par­tic­i­pants. The drug showed three-line im­prove­ment in par­tic­i­pants’ abil­i­ty to read an ET­DRS chart, a stan­dard eye chart used by oph­thal­mol­o­gists, Kedar said.

But the biotech isn’t alone in the race for a mi­otic-based eye drop. Ab­b­Vie is cur­rent­ly in Phase III with its can­di­date, pres­bysol, which it in­her­it­ed in the Al­ler­gan buy­out. PRX-100, in de­vel­op­ment by Pres­by­opia Ther­a­pies, is ex­pect­ed to en­ter Phase III this year, ac­cord­ing to Mod­ern Op­tom­e­try. And in a proof-of-con­cept study, 78% of pa­tients giv­en OS­RX Phar­ma­ceu­ti­cals’ Eye Fo­cus main­tained 20/40 vi­sion for 8 hours.

“There is a lot of ex­pec­ta­tion for eye drops for pres­by­opia to be­come very strong el­e­ments with­in the tools that eye care pro­fes­sion­als can fi­nal­ly pro­vide their pa­tients,” Kedar said.

In ad­di­tion to con­duct­ing its Phase III study, Ora­sis will use the Se­ries C to help pre­pare for a com­mer­cial launch.

“I mean, we’re not try­ing to elim­i­nate read­ing glass­es from the world. There are some peo­ple that would like to use the drop every day when they go to work, and some peo­ple may want to use it when they go Fri­day night to the restau­rant and they don’t want to use the read­ing glass­es … ” Kedar said. “So, this is re­al­ly … what we are go­ing to be able to of­fer so many peo­ple in the US and glob­al­ly.”

The fi­nanc­ing round was led by Bluestem Cap­i­tal and Vi­sion­ary Ven­tures, and joined by re­turn­ing in­vestors in­clud­ing Se­quoia Cap­i­tal, SBI (Japan) In­no­va­tion Fund, Mav­er­ick Ven­tures Is­rael and LifeSci Ven­ture Part­ners.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Biohaven CEO Vlad Coric

Bio­haven turns out a dud in fa­tal neu­rode­gen­er­a­tive dis­ease, cast­ing doubt on drug's chances in ALS

With one migraine drug on the market, Biohaven has gone big with its next phase of growth, targeting major neurodegenerative diseases in Alzheimer’s and ALS. The former effort has already gone up in smoke, and a new failure elsewhere in the pipeline could now bode poorly for the latter.

Biohaven’s verdiperstat failed to outperform placebo in reducing the symptoms of patients with multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder, according to a “focused analysis” of the drug’s Phase III trial in that disease toplined Monday.

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Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Scot Ebbinghaus, Merck Research Laboratories VP of clinical research

Mer­ck touts a con­fir­ma­to­ry Keytru­da win for liv­er can­cer as 'dan­gling' ac­cel­er­at­ed ap­proval saga march­es on

Accelerated approval for Merck’s Keytruda in a common form of liver cancer looked tenuous after a confirmatory study whiffed on two survival measures. But after ODAC recommended to keep the drug on the market back in April, the pharma giant said Monday another trial has brought better tidings.

The blockbuster PD-1 met its primary endpoint in statistically significant overall survival compared to placebo, Merck announced Monday morning, in a study evaluating Keytruda plus chemotherapy in 453 hepatocellular carcinoma patients from Asia. Though Merck didn’t report any specific figures, the company noted Keytruda also hit secondary endpoints for progression-free survival and objective response rate.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst

Perhaps anticipating a walkover with an FDA approval in hand, Biogen has instead faced a wall of pushback over its controversial Alzheimer’s med Aduhelm. With payers and clinics largely staying away, Biogen’s drug is posting some troubling safety signals that could derail the launch even further.

In a note to clients Friday, analysts from Baird revealed new safety data from the FDA’s Adverse Event Reporting System (FAERS) showing a troubling recurrence of ARIA in a crop of patients who have been dosed with Aduhelm.

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Evelo touts PhII win for in­flam­ma­tion pro­gram; In­novent, An­Heart claim in­ter­im PhII suc­cess in NSCLC

Flagship’s Evelo Biosciences is touting a win Monday in a Phase II study examining an oral treatment for inflammatory diseases.

Researchers saw a statistically significant reduction for the experimental drug EDP1815 in the Psoriasis Area and Severity Index (PASI) score compared to placebo after 16 weeks, Evelo announced Monday. The program is in clinical development for a wide range of inflammatory diseases such as psoriasis, atopic dermatitis and Covid-19.

Af­ter pump­ing the brakes on their An­gel­man syn­drome study, Ul­tragenyx and GeneTx are back in the race

Eleven months after high doses of Ultragenyx and GeneTx’s Angelman syndrome candidate temporarily caused some patients to lose their ability to walk, the FDA is allowing the partners to restart the trial — but with a much lower dose regimen.

Regulators have removed a clinical hold on Ultragenyx and GeneTx’s antisense oligonucleotide GTX-102, opening the door for more pediatric patients to enroll in a Phase I/II trial. The partners halted the trial in October after all five patients in the study experienced “lower extremity weakness” receiving the two highest doses during an escalation period. Two of them lost their ability to walk or bear weight.

Bio­gen can't es­cape co­pay kick­back law­suits as Hu­mana al­leges 'seed­ing' and sweep­ing' scheme

The Department of Justice made an example out of Biogen when it resolved allegations the drugmaker concocted a scheme to lure patients into taking its multiple sclerosis drugs by sponsoring their Medicare copays — which the feds say amount to illegal kickbacks. In a demonstration of accountability, Biogen paid $22 million to settle the claims.

One of Medicare’s contract insurers is now suing Biogen to get its own share of compensation.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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