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Cures For Hair Loss 2023 - News Feed
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Q32 Bio To Present Late-Breaking Results from the SIGNAL-AA Trial for Alopecia Areata
Q32 Bio, a clinical-stage biotechnology company focused on developing biologic therapeutics for autoimmune diseases, has announced that results from Part A of its Phase 2a SIGNAL-AA trial evaluating bempikibart in patients with alopecia areata (AA) will be presented as a late-breaking oral session at the 2025 American Academy of Dermatology (AAD) Annual Meeting.
Bempikibart (ADX-914) is a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. The IL-6 and TSLP pathways have been implicated in driving T cell-mediated pathology in various autoimmune diseases, including AA.
The SIGNAL-AA study is a randomized, placebo-controlled Phase 2a trial evaluating bempikibart in patients with severe and very severe alopecia areata. The results to be presented at AAD 2025 will offer new insights into its efficacy and safety profile.
According to Q32 Bio, bempikibart demonstrated promising clinical activity and was well-tolerated. While the press release did not provide actual efficacy data, the selection of the study for an oral late-breaking presentation suggests that the findings could be significant. The company states that the results support bempikibart's potential as a transformative treatment for alopecia areata.
The presentation will take place on Saturday March 8th, 2025, from 10:36 am to 10:48 am ET.
Olix Pharma Shows Safety in Phase 1 Trial for Androgenic Alopecia with OLX72021
Olix Pharmaceuticals has conducted a Phase 1 safety study in Australia for their androgenic alopecia treatment OLX72021. OLX72021 is an RNA-based treatment that is administered via intradermal injection into the balding scalp and suppresses the androgen receptor by reducing its gene expression. The trial was conducted with 30 males with androgenic alopecia who were split into 5 groups of six. The participants were injected with differing doses in six balding areas with follow-up over 8 weeks. No serious adverse events occurred, and there was no increase in adverse events with the dose.
Kintor Pharmaceuticals Continues Trials for KX-826 in Male Androgenic Alopecia Patients
Kintor Pharmaceuticals has enrolled its first subject in a Phase 2/3 trial of KX-826 1% (pyrilutamide) for treating male androgenic alopecia. The trial is a multi-centre, randomized, double-blind, vehicle-controlled phase 2/3 trial in which male AGA patients will apply the product topically. The phase 3 part of the trial will involve 25 research centers in China and will enroll 666 patients over 5 months. The trial will last 24 weeks, with a further month of safety observation.
Stemson Therapeutics Shuts Down
We reached out to Stemson Therapeutics for confirmation and have received the news that, yes, Stemson Therapeutics has shut down. Here is a quote from Geoff Hamiton, CEO. "I can confirm that we have shut down. It is a very disappointing outcome. I will say that pursuing a truly curative approach to hair loss with a true tissue regeneration therapy is still frontier science. While it offers the promise to be curative and durable, it is a significant challenge to develop such a solution involving living cellular medicines. It requires huge investment and dedication to the mission. There simply was no appetite or dedication in the biotech investment community during this historically bad biotech industry downturn to support Stemson with the major funding we needed to get the solution through the final stage of development and into the first clinical trial. We would love to see this technical approach picked back up in the future, as we firmly believe it will lead to a new breakthrough solution. But now was simply not our time to get the large investment needed."
Sun Pharma Delayed Release of Leqselvi for Alopecia Areata
Sun Pharma has had to delay the release of their JAK inhibitor deuruxolitinib (Leqselvi) thanks to an injunction from biopharma company Incyte. Incyte sells a JAK inhibitor called ruxolitinib, which is approved for non-hair loss-related indications like some blood cancers and graft-versus-host disease and as a topical for atopic dermatitis and vitiligo. Incyte claims that Leqselvi is structurally the same as ruxolitinib and, therefore, treads on their patent - which doesn't expire until 2026.
Sun Pharma will appeal the injunction; however, if they lose the appeal, they could be waiting until patent expiration before they can release their drug.
Arcutis Biotherapeutics Completes Enrollment for Phase 1b Study of ARQ-255 For Alopecia Areata
Arcutis Biotherapeutics, Inc. has completed enrollment in its Phase 1b study of ARQ-255, a topical suspension containing ivarmacitinib, a selective JAK1 inhibitor, designed to treat alopecia areata. Utilizing Arcutis' proprietary Deep Dermal Drug Delivery (4D) technology, ARQ-255 aims to penetrate deep into the skin to target inflammation at the hair follicle base. The study will assess the safety, tolerability, and pharmacokinetics of ARQ-255 in healthy adults and individuals with patchy alopecia areata. Results are anticipated in the first half of 2025.
Pelage Pharma Doses First Patients in Its Phase 2 Trial
Pelage Pharmaceuticals has announced that it has dosed the first participants in its Phase 2a trial for its androgenic alopecia treatment PP405. PP405 is purported to stimulate hair follicle stem cells, triggering dormant biological processes and reinvigorating the natural hair growth cycle. This compound is said to work by targeting specific cells within the hair follicle, aiming to reawaken their ability to promote hair growth that may have become inactive over time. The trial will include 60 men and women and study its efficacy and safety.
Recent Research Finds Potential in Sugar Molecule to Improve Hair Loss Outcomes
A recent study that has come out of a collaboration between Sheffield University and COMSATS University Pakistan has been published in Frontiers in Pharmacology. This study utilizes a sugar naturally found in the body called 2-deoxy-D-ribose (2dDR) in mice injected with testosterone. The researchers found that 2dDR was able to improve hair regrowth at the same level as minoxidil. While the results are interesting, it should be noted that the study has been conducted in mice and, therefore, might not translate well to humans.
Dr Bloxham Posts New Verteporfin Update
Dr Bloxham has posted the next update for two out of three patients in his observational verteporfin study. You can check out the video here. We will also be updating our Verteporfin page with the details of the video within the next few days, so make sure to keep checking.
Kang Stem Announces MOU with HLB Biostep and HLB Biocode
Kang Stem Biotech has signed a memorandum of understanding with HLB Biostep and HLB Biocode to develop an organoid-based platform for evaluating drug safety and efficacy and advancing cell therapy products. This collaboration aims to commercialize an alternative to animal testing, using organoid technology to predict human drug responses and enhance non-clinical toxicity evaluations. The company plans to seek early IND approval for a hair loss treatment using skin organoids. The CEO of Kang Stem has emphasized the synergistic benefits of combining the companies' expertise in organoid technology, treatment production, and evaluation techniques.