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SAN DIEGO — After 24 weeks of treatment with subcutaneously administered relative to baseline, results from a randomized clinical trial showed.
Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland
According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.
In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.
Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.
At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.
In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.
In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
No Serious Safety Signals Noted
There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.
“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”
Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.
[embed:render:related:node:267952]
One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.
“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”
Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.
SAN DIEGO — After 24 weeks of treatment with subcutaneously administered relative to baseline, results from a randomized clinical trial showed.
Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland
According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.
In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.
Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.
At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.
In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.
In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
No Serious Safety Signals Noted
There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.
“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”
Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.
[embed:render:related:node:267952]
One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.
“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”
Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.
SAN DIEGO — After 24 weeks of treatment with subcutaneously administered relative to baseline, results from a randomized clinical trial showed.
Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author Brian Kirby, MD, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland
According to a press release from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.
In a phase 2 study known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.
Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.
At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.
In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.
In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.
No Serious Safety Signals Noted
There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said.
“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”
Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.
[embed:render:related:node:267952]
One of the session moderators, Joel M. Gelfand, MD, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose.
“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”
Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.
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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167385</fileName> <TBEID>0C04F24F.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F24F</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240320T122837</QCDate> <firstPublished>20240320T130104</firstPublished> <LastPublished>20240320T130104</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240320T130104</CMSDate> <articleSource>FROM AAD 2024 </articleSource> <facebookInfo/> <meetingNumber>2884-24</meetingNumber> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText>MDedge News</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>sonelokimab 120 mg, about 43% of patients with moderate to severe hidradenitis suppurativa (HS) achieved a Hidradenitis Suppurativa Clinical Response (HiSCR75),</metaDescription> <articlePDF/> <teaserImage>299341</teaserImage> <teaser>Longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose.</teaser> <title>Novel Agent Shows Promise for Hidradenitis Suppurativa</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> <term>53</term> </sections> <topics> <term canonical="true">39212</term> <term>203</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012483.jpg</altRep> <description role="drol:caption">Dr. Brian Kirby</description> <description role="drol:credit">Ted Bosworth/MDedge News</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Novel Agent Shows Promise for Hidradenitis Suppurativa</title> <deck/> </itemMeta> <itemContent> <p><span class="dateline">SAN DIEGO </span>— After 24 weeks of treatment with subcutaneously administered <span class="tag metaDescription">sonelokimab 120 mg, about 43% of patients with moderate to severe hidradenitis suppurativa (HS) achieved a Hidradenitis Suppurativa Clinical Response (HiSCR75), defined as at least a 75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count</span> relative to baseline, results from a randomized clinical trial showed.</p> <p>Sonelokimab is a novel humanized nanobody that selectively binds to interleukin (IL)-17A and IL-17F, presenting author <span class="Hyperlink"><a href="https://svph.ie/healthcare-professionals/consultants-directory/prof-brian-kirby//">Brian Kirby, MD</a></span>, a dermatologist at St. Vincent’s Private Hospital, Dublin, Ireland, said during a late-breaking abstract session at the annual meeting of the American Academy of Dermatology. Sonelokimab is smaller than traditional monoclonal antibodies, he said, “which means it may be able to penetrate tissues better and stay there longer.” It is being developed by MoonLake Immunotherapeutics, based in Zug, Switzerland<br/><br/>[[{"fid":"299341","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Brian Kirby, MD, a consultant dermatologist at St. Vincent’s Hospital, Dublin.","field_file_image_credit[und][0][value]":"Ted Bosworth/MDedge News","field_file_image_caption[und][0][value]":"Dr. Brian Kirby"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]According to <span class="Hyperlink"><a href="https://ir.moonlaketx.com/news-releases/news-release-details/moonlake-announces-significant-improvements-nanobodyr">a press release</a></span> from the company, nanobodies represent a new generation of targeted therapies derived from antibodies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies.<br/><br/>In <span class="Hyperlink"><a href="https://www.clinicaltrials.gov/study/NCT05322473">a phase 2 study</a></span> known as the MIRA trial, researchers recruited 234 patients with moderate to severe HS to evaluate two different doses of sonelokimab (120 mg and 240 mg every 2 weeks) with a placebo control arm and adalimumab as an active reference arm. The primary endpoint of was the percentage of participants who achieved a HiSCR75. The study population included adults with Hurley Stage II or III HS who had HS lesions in 2 or more anatomical areas and a total abscess and inflammatory nodule (AN) count of 5 or more lesions; and had been treated with 2 or fewer biologics.<br/><br/>Dr. Kirby reported results from 67 patients in the sonelokimab 120 mg arm, 66 in the sonelokimab 240 mg arm, and 39 in the placebo arm. “It’s worth noting that the baseline AN count ranged between 12 and nearly 15, the mean draining tunnel count ranged between 2.9 and 3.7, and between 7% and 13% of patients were on concomitant antibiotics,” he said.<br/><br/>At 24 weeks, 43.3% of patients in the sonelokimab 120 mg arm achieved a HiSCR 75, compared with 34.8% of those in the sonelokimab 240 mg arm and 14.7% of those in the placebo arm, he reported. Meanwhile, 65.7% of patients in the sonelokimab 120 mg arm achieved an HiSCR 75, compared with 53% of those in the sonelokimab 240 mg arm and 27.9% of those in the placebo arm. Discontinuation rates were low and similar between treatment arms, with fewer than 10% of patients failing to complete week 24 of treatment.<br/><br/>In other findings, 69% of patients in the 120 mg arm achieved a HiSCR 50 at week 24 compared with 60.3% in the 240 mg arm; 56.9% in the 120 mg arm achieved a HiSCR 75 compared with 37.9% in the 240 mg arm; and 37.9% in the 120 mg arm achieved a HiSCR 75 compared with 27.6% in the 240 mg arm.<br/><br/>In addition, complete inflammatory remission as defined by the International HS Severity Score System (IHS4-100) continued to increase to week 24, with 24.1% of patients in the 120 mg arm achieving complete remission, compared with 15.5% of those in the 240 mg arm. Meaningful improvements in quality of life, skin pain, and HS symptoms reported by patients treated with sonelokimab were maintained or increased to week 24. Specifically, more than 60% of patients had a meaningful clinical improvement in their Dermatology Life Quality Index, over 45% had a minimum of a 30% increase in the Numerical Rating Scale **30, and more than 41% of patients reported absent or minimal symptoms on the Patient’s Global Impression of their Disease Severity, “which is a high bar to achieve in HS,” Dr. Kirby said.<br/><br/></p> <h2>No Serious Safety Signals Noted</h2> <p>There were no unexpected safety signals to week 24. The incidence of treatment-related adverse events was low, and there were no cases of inflammatory bowel disease. There were no serious infections, no major adverse cardiovascular event (MACE) reports, and no significant abnormalities on liver function tests. “There were also no safety signals on suicidal behavior, attempted suicides, or completed suicides,” he said. </p> <p>“As you would expect with in IL-17 inhibitor, there was a signal for candidiasis, but all cases were judged to be mild or moderate, and no cases led to discontinuation of treatment from the trial because of candidal infection.”<br/><br/>Based on these data, Dr. Kirby said that larger and longer-term phase 3 trials are planned to further examine the safety and efficacy of sonelokimab at the 120 mg dose for the treatment of moderate-to-severe HS.<br/><br/>One of the session moderators, <span class="Hyperlink"><a href="https://www.pennmedicine.org/providers/profile/joel-gelfand">Joel M. Gelfand, MD</a></span>, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, asked Dr. Kirby why he thought the lower dose resulted in generally better outcomes compared with the higher dose. <br/><br/>“There were no statistically significant differences between the two groups,” Dr. Kirby responded. “The 120 mg dose we know is highly effective in psoriasis, so there may be a ceiling effect. This may also be due to population variability, but the bottom line is that the 120 mg dose performs extremely well.”<br/><br/>Dr. Kirby disclosed that he has received research support from/has been a principal investigator for several pharmaceutical companies, including MoonLake Immunotherapeutics. Dr. Gelfand reported that he has been a consultant to and/or a member of the data safety monitoring board member for several pharmaceutical companies, including MoonLake.</p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM AAD 2024
