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<p><strong> By Cormac Sheridan <br /> Staff Writer </strong></p>
<p><span> DUBLIN – Active Biotech AB shares fell 37% on Tuesday to the announcement that its main drug, laquinimod, licensed from Teva Pharmaceuticals Industries Ltd., missed the primary test of a trial phase II in Huntington's disease </span></p>
<p><span> of three doses (0.5 mg, 1.0 mg or 1.5 mg daily) or a placebo group The primary endpoint was a change in the unified clbadification of Huntington's Disease </span><span> Sca </span><span> on </span><span> </span> – Total Motor Score (UHDRS-TMS), which measures the motor abilities of patients in multiple ways, including motion and control of limbs, hands, eyes, neck and tongue, although the drug had no effect on this measure. This has provided evidence that the drug had a logical physio effect in the brain, but it was obviously insufficient to have an impact on the symptoms of the patients. </p>
<p> The decision to stop the badignment of patients to the high dose arm in January 2016 did not help his cause, following the emergence of cardiovascular disease. symptoms in patients with multiple sclerosis (MS) on 1.2 mg and 1.5 mg in a phase III trial. Laquinimod, which has a long history of unsuccessful clinical development behind it, is a successor to roquinemex, an immunomodulatory compound originally developed by Pharmacia (now part of Pfizer Inc., based in New York), which was defeated by its cardiotoxicity. Laquinimod was identified from a screening program designed to eliminate these problems, but they emerged late in the MS program – in a second phase III trial. (See <em> BioWorld Today </em> January 5, 2016). </p>
<p> The drug was a precursor in the competition to develop an oral MS drug. Like Aubagio (teriflunomide), the unexpected blockbuster of Sanofi SA, laquinimod has demonstrated moderate levels of efficacy in MS. His positioning required a clean safety profile, which he could not guarantee. </p>
<p> Teva, of Pitach Tikva, Israel, took the drug for a nominal fee – only $ 5 million in advance and up to $ 87 million in In 2004, Active Biotech had favored a higher royalty rate and lower upfront and upfront payments. It has only received $ 22 million over the life of the alliance. Teva obviously invested a lot more in the development of the complex. "Big pharma, when they do it, they do it in multiple indications," Hans Kolam, Lund's CFO, Sweden Active Biotech, told <em> BioWorld </em>. </p>
<p> Teva had also conducted exploratory trials in systemic lupus erythematosus and Crohn's disease, but to no avail. The effort in Huntington was always a longhot. "It's a delicate indication," Kolam said. "It is wrong to say that we were surprised to see that he did not achieve his primary evaluation criterion." Teva has not yet formally terminated the program. "They will have to finalize the data badysis before deciding what to do," Kolam said. Investor Reaction, however, tells its own story </p>
<p> <strong> Towards New Approaches </strong> </p>
<p> Laquinimod looks more and more like the past of biotechnology rather than its future. None of the traditional small molecule drugs that have been tested in clinical trials has had an impact on Huntington's evolution. The dominant autosomal disorder is caused by an expansion of CAG repeats in the HTT huntingtin gene; the resulting misfolded proteins damage and eventually kill the neurons. </p>
<p> The focus of research has recently shifted to new approaches, following the dramatic, albeit preliminary, finding that an antisense oligonucleotide, IONIS-HTTRx, including Cambridge's Ionis Pharmaceuticals Inc. , Mbad. in cooperation with Roche Holding AG of Basel, Switzerland, is developing the mutated huntingtin protein, the main molecular cause of Huntington's disease, in patients' cerebrospinal fluid. (See <em> BioWorld </em> March 5, 2018). </p>
<p> Wave Life Sciences and its partner Takeda Pharmaceutical Co. Ltd. are in the clinic with two compounds, each of them silencing the expression of the HTT gene in an allele. specific mode. The topline data from the two phase Ib / IIa studies are expected in the first half of 2019. </p>
<p> The rest of the Active Biotech pipeline is oddly venerable while being preclinical. His best hope is the tasquinimod, an oral immunomodulatory drug that has generated promising preclinical data on multiple myeloma, added Kolam. It is thought that it works by targeting immunosuppressive cells in the tumor microenvironment. It improved progression-free survival in a phase III trial in prostate cancer, but development in this indication was discontinued due to failure to demonstrate a benefit of overall survival. Ipsens SA was the partner of this program. (See <em> BioWorld Today </em> 17 April 2015.) </p>
<p> Active Biotech is now seeking a new deal in multiple myeloma. "It's a huge market," Kolam said. "We need a partner who can add knowledge and skills in the field of multiple myeloma." He has already secured a partner for his third clinical program, Anyara. NeoTX Therapeutics Ltd. of Rehovot, Israel, is expected to begin a phase I trial of the tumor-targeting superantigen, in combination with a programmed cell death inhibitor 1 (PD-1), later this year. The therapeutic vaccine has already been tested in several indications on cancer more than ten years ago </p>
<p> Active Biotech shares (ACTI: Stockholm) closed Tuesday at 3 195 SEK (0.36 USD), down 37% at the end of Monday. </pre>
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