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EyesOn Clinical Updates
We've recently had EyesOn some of the Clinical data being released. Today we catch up with the details from Argenx, Zealand Pharma, and AbbVie data readouts.
Argenx’s FB102, a therapeutic candidate that the biotech purchased in its $2.2 billion acquisition of Forte Biosciences, has achieved its primary endpoint in a phase 2 coeliac disease trial.
In order to obtain FB102, an anti-CD122 antibody that performed well in a phase 1b vitiligo trial just weeks prior to the acquisition, Amsterdam-based Argenx agreed to purchase Forte in July. By then, Forte had phase 1 results on coeliac disease. Analysts were optimistic that FB102 would pass its midstage test after Teva’s competing medication candidate, TEV’408, cleared the threshold in a phase 2a coeliac disease clinical study last month.
In comparison to a placebo, in the phase 2 experiment FB102 was associated with a statistically significant improvement in villus height-to-crypt depts (Vh:Cd) at Day 78. The biotech produced the results in 126 persons with coeliac disease who were given an oral gluten challenge, demonstrating that intestinal damage caused by gluten can be avoided by inhibiting CD122.
Vh:Cd, a gauge of gut health, was chosen by Argenx as the main outcome. Teva’s main endpoint was Vh:Cd as well. Furthermore, according to Argenx, the primary endpoint was consistent with the VCIEL finding, which combines Vh:Cd with a measure of inflammation.
Argenx claimed that a number of metrics, including VCIEL, were in line with the main goal. According to the biotech, the findings offered more proof of the histologic, inflammatory, and clinical impacts of FB102. Nevertheless, argenx has not yet disclosed anything beyond the Vh:Cd analysis’s 0.0176 p-value. According to the business, safety was in line with earlier research.
Argenx intends to move FB102 into phase 3 development based on the data. By blocking IL-15 signalling pathways, the strategy keeps argenx at the forefront of coeliac disease treatment.
While Amgen and Novartis were researching IL-15 medications for coeliac disease but stopped development, FB102 targets CD122 to block IL-2 and IL-15 antibodies.
Teva intends to do a second phase 2 trial before moving on to crucial development, so Argenx has a chance to outbid its competitor for a lucrative opportunity. Analysts projected in July and September letters to investors that TEV’408 will launch in 2034 after FB102 in coeliac disease in 2031. Coeliac disease is viewed by analysts as a huge market.
Additionally, Argenx is evaluating FB102 for alopecia and vitiligo.
Argenx may become less dependent on efgartigimod, the FcRn medication that the biotech markets under the names Vyvgart and Vyvgart Hytrulo, if FB102, which it is also testing in vitiligo and alopecia, is brought to market. Alongside the announcement that efgartigimod failed a phase 3 Sjögren’s disease trial, Argenx released information about the success of FB102. In the middle of 2027, analysts anticipated encouraging findings in the indication. But because the trial was bound to fail, Argenx ended it early.
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More phase 2 data on Zealand Pharma’s amylin analogue, which is partnered with Roche, has been released. The data indicates that the medication candidate has a competitive effect on weight loss but a poor effect on blood sugar.
The information is from Zupreme-2, a midphase study that included 220 individuals with type 2 diabetes and overweight or obesity. Participants were given either a placebo or one of three doses of petrelintide, the medication candidate that Roche acquired for $1.65 billion plus milestones last year. Petrelintide’s competitiveness was called into question by Zupreme-1, a phase 2 trial that excluded individuals with type 2 diabetes.
After Zupreme-2’s topline data was released, doubts still exist. At Week 28, Zealand reported a mean weight loss of up to 9.2% on petrelintide as opposed to 2% on a placebo. Although type 2 diabetics usually lose less weight, Zealand nearly matched Zupreme-1’s 9.8% outcome.
Analysts described the Zupreme-2 weight-loss findings as fascinating in a note to investors. The analysts noted that the weight reduction Eli Lilly reported in a phase 2 trial of its amylin receptor agonist, eloralintide, mirrored the 7.2% placebo-adjusted outcome. Although it targets GLP-1 and amylin, Novo’s CagriSema caused more significant weight loss in phase 3.
Petrelintide did not perform as well in cross-trial blood sugar comparisons. The medication candidate’s Week 28 HbA1c reduction of 0.65% was below the competitors’ range of 1.3% to 2.1%. After controlling for placebo, the difference between petrrelintide and the competition is less since the control group’s HbA1c increased. According to the experts, an increase in HbA1c is uncommon in these kinds of trials.
A crucial component of Zealand and Roche’s petrelintide pitch, tolerability, made an impression once more. According to Zealand, the profile of petrelintide was essentially the same as that of a placebo. Compared to 1.7% of individuals receiving a placebo, 1.9% of patients in the petrelintide arms stopped taking their medication due to gastrointestinal side effects.
Following the readout, analysts stated that they still think petrelintide’s unique tolerability profile provides patients with a better treatment experience. However, after evaluating data from both phase 2 studies, the analysts concluded that Zupreme-2’s HbA1c and weight reduction were disappointing.
According to the analysts’ present assessment, petrelintide will probably be employed mostly in the maintenance scenario, necessitating a therapeutic intervention with placebo-like tolerability for long-term use. A double-digit weight decrease in the overweight population may result in normal weight and reduced cardiovascular risk, so there will probably be clinical benefit there as well.
Recently, Roche started recruiting people for three phase 3 petrelintide trials. Zupreme-4, a crucial program, is recruiting 600 individuals with type 2 diabetes and overweight or obesity.
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AbbVie’s $8.7 billion investment in Cerevel Therapeutics has paid off with its first FDA approval, despite a clinical failure from the previous year still hanging over the company.
Tavapadon, now known as Juvmo, was approved by US regulators last week as a novel medication and the first selective D1/D5 receptor in adult Parkinson’s disease patients. The FDA’s list of new medication approvals for 2026 was where the announcement initially appeared.
According to AbbVie, the green light represents the first dopaminergic advancement in Parkinson’s treatment in decades. Additionally, it validates the drugmaker’s acquisition of Cerevel in late 2023 with a focus on neuroscience, making it the first asset from that deal to be approved by U.S. regulators.
Even though emraclidine, another Cerevel product, was thought to be the M&A play’s crown jewel, two midstage trial failures in early 2025 upset the trajectory of the highly anticipated asset in schizophrenia, increasing the pressure on Tavapadon to be successful.
Now, Juvmo joins a crowded field of Parkinson’s therapy that is still dominated by tried-and-true medications like levodopa and carbidopa.
However, according to AbbVie, Juvmo’s unique mode of action truly gives doctors the chance to treat patients in ways that are not possible with the present treatments.
The company articulated issues with current treatments by pointing out that individuals receiving levodopa experience motor fluctuations, which are periods of poor motor symptom control as levodopa begins to lose its impact, and that these patients require increased adjustments to their therapy over time.
Additional adverse effects, such as obsessive behaviours, sleeplessness, and possible withdrawal symptoms from dopamine agonists, are associated with other licensed and experimental Parkinson’s medications that target dopamine receptors like D2 and D3.
The business stated that it expects patients with Parkinson’s disease won’t have to face such trade-offs when choosing a course of treatment thanks to Juvmo.
Nearly a year ago today, AbbVie filed a new medication application for Juvmo, feeling confident after winning three phase 3 trials in Parkinson’s disease with Tempo-1, Tempo-2, and Tempo-3.
The trial achieved its main goal when patients on Juvmo showed a 10.3-point improvement on a measure of motor function at 26 weeks compared to a 1.2-point improvement on a placebo in the final readout of the bunch from Tempo-2. While the Tempo-3 study examined Juvmo as an adjuvant therapy to levodopa in individuals with motor fluctuations, that trial and Tempo-1, which achieved its own victory lap in September 2024, evaluated AbbVie’s medication in patients with early Parkinson’s disease.
According to AbbVie, the results of the most recent trial showed that patients’ symptoms were successfully controlled without dyskinesia or involuntary movements when Juvmo was used in addition to levodopa.
According to the company, Juvmo really concentrates its benefit on that motor pathway by locking in on the D1 and D5 receptors. By doing this, hopefully efficacy can be achieved without having to make trade-offs with some of those other adverse events that are typically associated with the D2, D3s, or the fluctuations seen with levodopa.
AbbVie pointed out that previous efforts to create D1 and D5 agonists, such as Juvmo, have all failed, especially when it comes to full agonism. The company’s medication has an advantage because of the selectivity and partial agonism created with Juvmo.
According to the business, the latest FDA approval completes AbbVie’s wider portfolio by assisting patients throughout their whole Parkinson’s disease journey. Additionally, the Chicago pharmacy sells the more common carbidopa-levodopa prodrug cocktail Vyalev, which is likewise recommended to regulate motor fluctuations in individuals with severe disease, as well as Duopa, a combination of carbidopa and levodopa.
Juvmo’s FDA-approved label will allow it to be used both alone in the early stages of treatment and in conjunction with levodopa to help patients with motor irregularities later in the course of their illness.
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