Sign up now to receive our regular news briefs.

Israeli Start-Up Alcobra Develops New Treatment for Attention Deficit Disorder

December 2, 2013 3:26 pm 2 comments
Israel's Alcobra Pharmaceuticals has a new non-stimulant treatment for ADHD.

Israel's Alcobra Pharmaceuticals has a new non-stimulant treatment for ADHD.

Israeli pharmaceutical start-up Alcobra Pharmaceuticals is listed on the NASDAQ electronic stock exchange under the ticker ADHD, the disease it treats with a non-stimulant compound that is expected to come to the market in 2015.

In an interview with Israeli business daily Globes, CEO Dr. Yaron Daniely explained how the company was originally created in 2008 to develop the molecule metadoxine to help inhibit the effects of alcohol on the brain.

“The goal was to create a pill that would quickly reduce blood alcohol levels, so that people would be able to drive safely,” explains Daniely. “It turned out the drug had no significant impact on removing alcohol from the blood, but it had a very significant impact on cognitive ability. In driving, memory, and attention tests that were conducted, it was as though those people were not drunk, despite the fact that, in terms of the amount of alcohol in their blood, it was not clear that they would be able to stand on their own two feet. So the idea to treat Attention Deficit Disorder came about.”

A pilot the company conducted in 2010 among 40 adults with ADHD showed “an immediate and significant improvement in attention tests. As a result of this, the company reinvented itself,” Daniely said, which is when he was named by researchers Dr. Dalia Megiddo and Udi Gilboa to be its new CEO.

Bilingual with a Ph.D. from the Sackler Institute of Graduate Biomedical Sciences at the New York University School of Medicine, an NIH Visiting Fellow in Cell Biology, a Postdoctoral Fellow in the Department of Molecular Cell Biology at The Weizmann Institute for Science, in Rehovot, and an MBA from the Technion – Israel Institute of Technology, Daniely also was VP Business Development at Gamida Cell Ltd., managing its joint venture with Teva Pharmaceutical Industries Ltd.(NYSE: TEVA; TASE: TEVA) to develop a cancer drug.

The idea was to approach TEVA to fund the start-up, which it did with $5 million to fund its first tests. But with TEVA later in a management crisis, and its options to increase its position in Alcobra expired, the team sought an IPO on the NASDAQ, which has since net it some $60 million in proceeds and a market capitalization of $220 million, more than enough to fund its final tests and market launch.

Daniely said the chemical compound metadoxine has been approved for 40 years for the treatment of liver disease in third-world countries, including India, China, Russia, and Thailand. The company has registered a patent for the use of metadoxine for neurological conditions, through a timed-release of the substance, so its effect on the patient lasts a few hours.

Globes said that Alcobra has no labs, its raw materials are manufactured by a third party in Germany, and the pills themselves are manufactured in the US. The company believes that the drug combines the benefits of the two existing classes of ADHD drugs – the stimulants, such as Ritalin and Concerta, and the non-stimulant drugs, such as Strattera – and claims that it does not have their drawbacks.

According to the company, the results of the clinical trials showed that the drug is not addictive, worked faster and was twice as effective as the existing non-stimulant drugs, and had a similar anti-ADHD effect to that of the stimulants. It primarily affects cognitive ability, less so hyperactivity.

Daniely advised other Israeli start-ups to follow four lessons from Alcobra’s successful IPO. “The first element was quality, and a refusal to compromise,” he said. “Alcobra, from day one, tried to be different from other companies. We have an almost pedantic stubbornness not to do things too small or too short, but rather to do the things the way we would if we were a company in Silicon Valley. Therefore, our Phase II trial didn’t include 20 people over two weeks, instead, it included 120 people, with a placebo control, over the course of six weeks, using the exact same measures that all the ADHD drugs in the world are measured by. Many companies understand too late that they are conducting poorer trials without the appropriate controls.”

The second element was the company’s target market. “There’s nothing like ADHD,” he says. “First of all, people understand the market; there are drugs, it is known how much each company is selling and why, there are patients, there is a market that turns over $4 billion each year in the US. Also, people think they understand what ADHD is. It affects almost everyone, their kid, or their nephew.”

A third element is the pace of development: “With ADHD, unlike rare cancers, participants for clinical trials are incredibly easy to find. So our time to market and our ability to build our development process are such that almost every month we have good news for shareholders. The phase III trial will include 300 patients, in 20 medical centers, over the course of six months.”

The fourth element that helped secure funding was his native-English speaking ability, personal CV and track record and a decision to invite well-known professionals from the ADHD research community to be on their team, in this case, Prof. Lenard Adler, a researcher from NYU and an expert in ADHD drug development, who serves as head of the clinical committee that advises the company. “When someone like him sits next to you and says: ‘I conducted the trial and I stand behind the results,’ they can’t blow you off. Israeli entrepreneurs need to understand this and bring these people to their companies, so they can bridge the gap,” Daniely said.

While the company tried to get funding in Israel, where ADHD is less frequently diagnosed, its success in raising money on the NASDAQ has led many other young pharma companies to its doors, seeking advice. Its success has also led to new projects.

“Many things happened at the company, and our ability to implement plans grew. We had a tremendous opportunity to treat fragile X syndrome, which is associated with autism. It is a very common condition, which is very difficult for many who suffer from it, and there is no treatment. In a trial we conducted on animals with a kind of fragile X, we came up with outstanding results. It completely normalized learning, memory, social behavior, and communication. In parallel, the market in the US was still on fire, and said, ‘go, secure the investment, and bring in more cash,'” Daniely said.

The funds Alcobra raised guarantee that the company will have full funding until it is approved as a drug for adult ADHD, which, according to Daniely, is expected to reach market in late 2015, and for children soon afterwards. The money will also fund the fragile X trial.

2 Comments

  • In this period of financial crisis, you usually do not have to spend huge amount of money just to find out girls
    get their clothes off in front individuals. You have to discover once the nude models from the sex chat website can be extremely beautiful and
    deliciously attractive. Military husbands stationed in the Middle
    East have been in a position to witness the birth of an youngster through webcams.

  • Davida Rosenberg

    Please update me when this will be available in the U.S.
    A family member age 36 male.. has suffered his whole young life with this condition.

Leave a Reply

Please note: comments may be published in the Algemeiner print edition. Comments written in all caps will be deleted.


Current day month ye@r *

More...

  • Arts and Culture First English-Language Trailer Debuts for Natalie Portman’s Hebrew Film ‘A Tale of Love and Darkness,’ Based on Amos Oz’s Memoir (VIDEO)

    First English-Language Trailer Debuts for Natalie Portman’s Hebrew Film ‘A Tale of Love and Darkness,’ Based on Amos Oz’s Memoir (VIDEO)

    The first English-language trailer for Natalie Portman’s directorial debut — A Tale of Love and Darkness — based on Israeli author Amos Oz’s memoir, was released on Thursday. The movie, originally filmed in Hebrew, tells the story of Oz’s childhood in Jerusalem at the end of the British Mandate and the early years of Israel’s independence. Portman, who was born in Israel and speaks fluent Hebrew, plays the lead role of Fania, the author’s mother. She struggles to raise her son as she deals with inner demons, a […]

    Read more →
  • Features As Berlin Prices Rise, Israelis Turn East for German Real-Estate Bargains

    As Berlin Prices Rise, Israelis Turn East for German Real-Estate Bargains

    JNS.org – Sonnenallee, a street in Berlin’s Neukölln district, looks like it comes straight out of an Arab city — so much so that it goes by the nickname “Gaza Strip.” Kebab and bakery shops are advertised in Arabic; men sit in men-only coffee shops; and bridal shop windows showcase glittery, not-so-stylish gowns. But take a random turn, and you’ll find a swath of bars, burger joints, and Indian restaurants where hip Berliners announce that they have arrived to urban coolness. […]

    Read more →
  • Arts and Culture Israeli Actress Gal Gadot Slays in ‘Wonder Woman’ Trailer (VIDEO)

    Israeli Actress Gal Gadot Slays in ‘Wonder Woman’ Trailer (VIDEO)

    Israeli actress Gal Gadot engages in fierce action sequences in the new Wonder Woman trailer, which Warner Bros. premiered during the San Diego Comic-Con on Saturday. The nearly 3-minute trailer, the first to debut for the superhero film, shows scenes of Diana, princess of the Amazons, fighting alongside men in the battle against the world’s toughest enemies. The first shot of the video shows Wonder Woman discovering a man, Steve Trevor (played by actor Chris Pine), washed ashore. The clip then takes viewers to the all-female island where Wonder Woman was born. […]

    Read more →
  • Arts and Culture A Theatrical Look at Diplomacy and the Oslo Accords (REVIEW)

    A Theatrical Look at Diplomacy and the Oslo Accords (REVIEW)

    Is diplomacy worthwhile, even if the end result isn’t what we hoped for? That is the question, among many others, posed by the new play Oslo, by J.T. Rogers. Making its New York debut at Lincoln Center, the play examines the secret diplomatic process that led to the historic 1993 peace accords. The character of Shimon Peres makes an appearance onstage — and he, along with Yitzhak Rabin and Yasser Arafat, tower over the proceedings. But they mainly do so in absentia. Instead, […]

    Read more →
  • Spirituality/Tradition Sports Israeli Trailblazer Dean Kremer Brings Jewish Values to Nascent Pro Baseball Career

    Israeli Trailblazer Dean Kremer Brings Jewish Values to Nascent Pro Baseball Career

    JNS.org – Other than being part of the Los Angeles Dodgers organization, Sandy Koufax and Dean Kremer have something else in common: a respect for Jewish tradition. Koufax — who was recently ranked by ESPN as the best left-handed pitcher in Major League Baseball (MLB) history — decided not to pitch Game 1 of the 1965 World Series because the game fell on Yom Kippur. “I would do the same,” Kremer said in an interview. Last month, the 20-year-old Kremer became […]

    Read more →
  • Arts and Culture Lead Guitarist of British Rock Band Queen Asks Adam Lambert to Sing in Hebrew During Upcoming Israel Concert

    Lead Guitarist of British Rock Band Queen Asks Adam Lambert to Sing in Hebrew During Upcoming Israel Concert

    The famed lead guitarist of British rock band Queen, Brian May, encouraged Jewish singer-songwriter Adam Lambert to perform in Hebrew during their upcoming joint concert in Israel, an entertainment industry advocacy organization reported on Tuesday. During a recent interview with Israeli television personality Assi Azar, May was played a 2005 video of Lambert singing the popular song Shir L’Shalom, (Song for Peace). May was so impressed by Lambert’s singing of the Hebrew track that he told the American singer, “We have to do that. Let’s […]

    Read more →
  • Sports Kenyan Marathoner to Compete for Israel in Rio Olympics

    Kenyan Marathoner to Compete for Israel in Rio Olympics

    JNS.org – Kenyan-born marathoner Lonah Chemtai is expected to compete for Israel at the Olympics Games in Rio De Janeiro, Brazil next month after gaining a last minute approval. “I am very proud [to represent Israel] and I hope to achieve a new personal best time,” Chemtai told Reuters. Chemtai, who grew up a rural village in western Kenya, first came to Israel in 2009 to care of the children of her country’s ambassador to Israel. The 27-year-old runner recently gained […]

    Read more →
  • Arts and Culture Jewish Identity Will Laughs Lead to Love on Show About Orthodox Dating?

    Will Laughs Lead to Love on Show About Orthodox Dating?

    To date or not to date? That is not the question for most Modern Orthodox singles in New York. The question is when will they find their future spouses, and when will their families stop nagging them about having babies? Inspired by the success of the Israeli show “Srugim,” Leah Gottfried, 25, decided she would create and star in her own show, “Soon By You.” “Dating is so serious already,” Gottfried said. “We wanted to take a lighter approach and laugh at the […]

    Read more →