MindMed Appoints Matt Wiley as Chief Commercial Officer to Lead MM120 Launch Strategy
• MindMed has appointed Matt Wiley as Chief Commercial Officer to oversee the commercial strategy for MM120 ODT, a potential treatment for generalized anxiety disorder and major depressive disorder.
• Wiley brings over 25 years of experience in specialty product launches, including successful commercialization of neuroscience therapeutics like XYREM®, which achieved blockbuster status under his leadership.
• The appointment comes as MindMed prepares for multiple Phase 3 clinical readouts in 2026, positioning the company to potentially address the needs of over 50 million people suffering from anxiety and depression.
Edesa Biotech Advances Vitiligo Treatment Program, Secures $15M Funding for EB06 Development
• Edesa Biotech is preparing to submit regulatory data to FDA for EB06, an anti-CXCL10 monoclonal antibody targeting vitiligo, with submissions planned for mid-2025.
• The company secured $15 million in gross proceeds through a private placement, strengthening its position to advance the vitiligo program through clinical development.
• Phase 2 clinical trial for moderate-to-severe nonsegmental vitiligo patients is anticipated to deliver topline results within 12-18 months after FDA clearance.
Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia
• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia.
• The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants.
• Early results indicated that improvements were observed as early as 5 weeks into the treatment.
• The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.
Nektar's Rezpegaldesleukin Receives FDA Fast Track for Atopic Dermatitis Treatment
• The FDA has granted Fast Track designation to rezpegaldesleukin for moderate-to-severe atopic dermatitis in patients 12 years and older.
• Rezpegaldesleukin targets the interleukin-2 receptor complex, stimulating regulatory T cell proliferation to restore immune balance.
• Phase 2b REZOLVE-AD study has completed enrollment, with topline data expected in Q2 2025, evaluating EASI score improvements.
• Fast Track designation allows for more frequent interactions with the FDA, potentially accelerating the drug's development and approval.
VYNE Therapeutics Advances VYN201 and VYN202 in Vitiligo and Psoriasis Trials
• VYNE Therapeutics completes enrollment for Phase 2b trial of VYN201 gel (repibresib) in nonsegmental vitiligo, with top-line data expected mid-2025.
• A Phase 1b trial of oral VYN202 for moderate-to-severe plaque psoriasis has begun, with results anticipated by the end of 2025.
• Both VYN201 and VYN202 are BET inhibitors designed to address immune-mediated conditions with high unmet needs.
FDA Anticipated to Decide on Dupixent, Pz-cel, and Roflumilast Foam for Dermatologic Conditions by Mid-2025
• The FDA is reviewing Dupixent for chronic spontaneous urticaria, with a PDUFA date of April 18, 2025, potentially offering a novel targeted therapy after a decade of limited options.
• Abeona Therapeutics' pz-cel for recessive dystrophic epidermolysis bullosa has a resubmitted BLA with a PDUFA date of April 29, 2025, following a Complete Response Letter earlier in 2024.
• Arcutis Biotherapeutics' roflumilast foam for scalp and body psoriasis has a PDUFA date of May 22, 2025, offering a steroid-free alternative for hard-to-treat areas.
VYN201 Shows Promise in Phase 1b Trial for Non-Segmental Vitiligo
• A Phase 1b trial of VYN201 topical gel demonstrated safety and tolerability in patients with active non-segmental vitiligo (aNSV).
• The study showed a dose-dependent clinical response, with the 2% dose cohort experiencing a -39.0% change in F-VASI score after 16 weeks.
• VYN201, a topical small molecule BET inhibitor, aims to minimize disease severity and encourage anti-inflammatory effects in vitiligo patients.
• The findings suggest VYN201 could address the significant unmet need for new therapies in vitiligo, offering a novel approach beyond existing treatments.
Batiraxcept Fails to Meet Primary Endpoint in Phase III Ovarian Cancer Trial
• Aravive's batiraxcept demonstrated no significant difference in median progression-free survival compared to paclitaxel in platinum-resistant recurrent ovarian cancer patients.
• The Phase III trial termination led to a significant drop in batiraxcept's Likelihood of Approval (LoA) for ovarian cancer, decreasing by 10 points to 1%.
• The study found no detriment to overall survival and identified no new safety signals, despite the failure to meet the primary endpoint.
• The trial compared batiraxcept in combination with paclitaxel versus placebo in combination with paclitaxel.
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