J&J drops Addex’s epilepsy treatment after flunking in Phase II

July 25, 2024  Source: drugdu 62

"/Johnson and Johnson (J&J) Innovative Medicine has decided to halt the development of its epilepsy drug, three months after a Phase II trial with the drug failed to meet its endpoints.

The therapy was developed in partnership with Addex Therapeutics, which was quick to add that its collaboration with J&J is still ongoing as the companies analyse data from the placebo-controlled Phase II trial (NCT04836559). The drug failed to achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count.

Addex’s stock has not recovered from the 53.3% nosedive it took after the Phase II results were released on 29 April. The company’s stock is now trading at $8.06 on the Nasdaq, down 49.9% from what it was worth before the news of Phase II results was announced.

ADX71149 is a positive allosteric modulator (PAM) of metabotropic glutamate receptor-2 (mGlu2 receptor), which plays a key role in seizure initiation and spread. The drug was developed as part of a partnership with J&J signed in 2004.

J&J has observed a decline in sales in Q2, with a 12.8% drop in net earnings to $4.6bn from $5.3bn earned in the same quarter of the previous year. Neuroscience is a key segment for J&J, generating $1.8bn in revenue last year, per the company’s financials.

The company’s depression treatment Spravato (esketamine) generated $206m in sales last year. The therapy’s sales are predicted to soar to $2.3bn in 2030, as per GlobalData analysis. The increase in sales is expected to be propelled by the label expansion of Spravato, as J&J is looking to increase its indications for use.

Another neuroscience candidate in J&J’s pipeline is seltorexant. The human orexin-2 receptor agonist proved successful as an adjunct treatment for major depressive disorder and met all the primary and secondary endpoints in a Phase III trial. GlobalData expects seltorexant to pull in $610m in sales by 2030.

Addex’s pipeline consists of allosteric modulator assets such as dipraglurant and a GABA-B PAM candidate for the treatment of chronic cough. The company plans to start a Phase II trial evaluating dipraglurant, a metabotropic glutamate subtype 5 (mGlu5) negative allosteric modulator, for post-stroke sensorimotor recovery this year.

In April, Addex spun out a new company, Neurosterix, to develop its preclinical neurological assets. In exchange for the drug candidates and technology, Addex received SFr5m ($5.5m) and a 20% equity in Neurosterix.

https://www.pharmaceutical-technology.com/news/jj-drops-addexs-epilepsy-treatment-after-flunking-in-phase-ii/

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