Cassiopea (SKIN)

Cassiopea N 

Valor: 28252872 / Symbol: SKIN
  • 39.50 CHF
  • -0.25% -0.100
  • 24.01.2020 17:30:42
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Ja, sie haben heute das

Ja, sie haben heute das Meeting mit der FDA: Cassiopea has an End of Phase II Meeting with FDA scheduled on November 13, 2019, to discuss the AGA Phase III Program in males with clascoterone solution. 

Diese Studie wurde bereits designed usw. und könnte Anfang 2020 mit dem OK der FDA starten. Aber ich habe den Eindruck, dass Cassiopea bis zur potentiellen Winlevi-Zulassung sparen will. 

Heute startet aber die Ph 2 Studie in Frauen:

Cassiopea Announces First Patient to be Enrolled in Phase II Trial for the Treatment of Androgenetic Alopecia in Females with Clascoterone Solution

Lainate, Italy – November 13, 2019 - Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company focused on developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has received approval from the German Authority BfArM and the coordinating ethical committee and will now proceed to enrol the first patient in a Phase II trial investigating clascoterone solution for the treatment of androgenetic alopecia (AGA) in females.

The Phase II multicenter, prospective, randomized, double-blind, vehicle controlled, dose ranging study will evaluate the efficacy and safety of clascoterone solution for the treatment of AGA in females. The six-month study will enroll approximately 280 female subjects between 18-55 years of age with mild to moderate AGA in Germany. The four-arm study will enroll 70 subjects per arm in each of four treatment groups: clascoterone solution 5% BID (twice daily), clascoterone solution 7.5% BID (twice daily), minoxidil solution 2% BID (twice daily) and vehicle BID (twice daily). The co-primary endpoints are: (1) change from baseline in non-vellus Target Area Hair Count (TAHC) at month 6 in comparison to vehicle and (2) Hair Growth Assessment (HGA) score at month 6 in comparison to vehicle.

Clascoterone, a new chemical entity, is a proposed first-in-class topical androgen receptor inhibitor currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of acne (in a 1% cream) and in late stage development for the treatment of AGA (in a higher strength solution). Laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles. Because of clascoterone’s likely local effect at the site of application, the risk of off-target, or systemic side effects, is minimized.

AGA is a leading cause of hair loss in men and women. In AGA, high local concentrations of DHT bind to androgen receptors within the scalp hair follicles, resulting in shortening of the hair cycle and gradual miniaturization of scalp follicles in men and women with a genetic predisposition. Over time, these progressively smaller, thinner hair follicles are unable to produce new hair, thus resulting in AGA’s characteristic patterned baldness. DHT dependent effects are considered, in most cases, reversible, such that AGA could be responsive to medical treatment with clascoterone solution through its proposed MOA of direct inhibition of testosterone and DHT binding to local hair follicle androgen receptors. Clascoterone has the potential to be the only topical antiandrogen for use in both men and women with AGA if approved by the FDA.

Based on early clinical review, Cassiopea believes that topical clascoterone will not have the contraindications and safety warnings of an orally administered androgen modulator used for the treatment of AGA in men. It appears Clascoterone does not interfere with the hormonal and, in particular, testosterone profiles of male subjects; libido and sexual behavior changes have not been observed in clinical trials to date. Clascoterone is quickly metabolized to cortexolone, a metabolite with a known safety profile. Due to its rapid metabolism and local activity, there appears to be limited systemic exposure to clascoterone and thus potential systemic side effects are minimized.

On April 16, 2019, Cassiopea announced topline results from the Phase II Dose Ranging trial in males demonstrating statistically significant improvement versus vehicle for TAHC for each dose tested along with directional improvement for HGA at twelve months. No treatment-related serious adverse events among patients were recorded during the trial; local skin reactions, if present, were similar to vehicle and predominantly classified as mild.  Cassiopea has an End of Phase II Meeting with FDA scheduled on November 13, 2019, to discuss the AGA Phase III Program in males with clascoterone solution.

“Clascoterone, a unique topical androgen receptor inhibitor, has shown a remarkable increase in hair growth as compared to vehicle with minimal side effects in the Phase II Dose Ranging Study in males. If FDA approved, it will be a very welcomed and important therapy for female and male patterned hair loss, androgenetic alopecia,” said Wilma Bergfeld, Professor of Dermatology and Pathology at Cleveland Clinic and Past President, American Academy of Dermatology and American Society of Dermatopathology.

 “If approved, clascoterone solution will be the first new mechanism of action for the treatment of androgenetic alopecia in decades, offering dermatologists and patients a new and potentially effective therapeutic alternative,” said Diana Harbort, CEO of Cassiopea. “We’re focused on the urgency to treat skin and scalp conditions that can leave not only physical scars, but also emotional scars. That’s why innovation is so critical. We are committed to finding a new pathway to treat the most common form of hair loss affecting both men and women.”

DISCLAIMER I'm long with Cassiopea, Obseva, Cosmo, Redhill Biopharma, Acacia Pharma, Santhera.

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Sol-Gel macht nicht besser als Cassiopea

Sol-Gel Announces Positive Top-Line Phase 3 Trial Results of Twyneo® for the Treatment of Acne Vulgaris

Placebo-adjusted Results

  Clascoterone (Cassiopea) Twyneo (Sol-Gel)
2 pt reduction on IGA

12%

19%
Inflammatory Lesion Count -5.5 -4.5
Non-inflammatory Lesion Count -7.5 -8.5
PDUFA 27. August wahrscheinlich Ende 2021

Wichtig: es gibt eine sehr hohe Diskrepanz zwischen den beiden Studien (SGT-65-04 and SGT-65-05) von Sol-Gel: http://ir.sol-gel.com/news-releases/news-release-details/sol-gel-announces-positive-top-line-phase-3-trial-results

Die beiden Studien von Cassiopea haben im Gegenteil ähnlichere Ergebnisse: https://www.cassiopea.com/2018/10/18/cassiopea-announces-attainment-of-all-primary-and-secondary-endpoints-and-highly-satisfactory-safety-data-in-its-phase-3-for-winlevi-clascoterone-cream-in-treating-acne/

DISCLAIMER I'm long with Cassiopea, Obseva, Cosmo, Redhill Biopharma, Acacia Pharma, Santhera.

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Tolle/Aktuelle Zusammenfassung

https://themarket.ch/fokus/vorlage-fokus-161-ld.1390

Interessant zu lesen, dass NZZ am Ausbau einer eigenen Vertriebsorganisation nicht glaubt. 

DISCLAIMER I'm long with Cassiopea, Obseva, Cosmo, Redhill Biopharma, Acacia Pharma, Santhera.

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Meine Meinung: Cosmo hat sich

Meine Meinung: Cosmo hat sich im letzten Jahr völlig neu erfunden, wie die jüngsten Investitionen in RedHill und Acacia Pharma zeigen. Cosmo sagte auf einer Investorenkonferenz Ende letzten Jahres: Cosmo's einziges Interesse an Cassiopea ist finanziell.

Es scheint mir klar zu sein, dass Cosmo seinen Anteil an Cassiopea verkaufen wird, um seine derzeitige Strategie der Umwandlung in ein Pharmaunternehmen fortzusetzen. Die Frage ist: Wann? Vor oder nach der US-Zulassung von Clascoterone?

Und auch zu welchem Preis? Ist eine Firma bereit, 800 Millionen bis 1 Milliarde Schweizer Franken auf den Tisch zu legen, um Cassiopea zu übernehmen? Wenn ja, welche?

Zur Erinnerung:

- Cassiopea hat kein Cash mehr (Kreditlinie von Cosmo)

- Pipeline: 

> Clascoterone gegen Akne: PDUFA Ende August
> Clascoterone gegen Haarausfall: Start der Ph. 3 Studien dieses Jahr > Ich denke, dass diese Studien schon jetzt bereit zu starten sind, aber Cassiopea/Cosmo wollen sparen und den Start verzögern (Ein Zeichen der Bereitschaft zum Verkauf?)
> Clascoterone gegen Haarausfall (für Frauen): Phase 2 DR startete Ende 2019
> Akne-Antibiotikum: verbesserte Formel, Phase 2 wird voraussichtlich H2-2019 starten
> Mittel gegen Genitalwarzen: verbesserte Formel, Phase 2 wird voraussichtlich H2-2019 starten / oder Verkauf des Produkts (weil es keine Dermatologie ist)

DISCLAIMER I'm long with Cassiopea, Obseva, Cosmo, Redhill Biopharma, Acacia Pharma, Santhera.

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