Ligand Completes Merger with Channel Therapeutics, Launching ZELSUVMI™ for Molluscum Contagiosum
Breakthrough Clinical Results
Ligand Pharmaceuticals announced the completion of its merger with Channel Therapeutics, forming Pelthos Therapeutics. Pelthos will launch ZELSUVMI™ (berdazimer), the first FDA-approved home-administered treatment for molluscum contagiosum, a common skin infection. The merger included a $50.1 million equity capital raise, with Ligand investing $18 million and retaining a 13% royalty on ZELSUVMI sales. Pelthos will trade on the NYSE American under the symbol "PTHS". The company will also continue evaluating Channel's NaV 1.7 programs for chronic pain treatment.
Key Highlights
- Completion of Ligand's merger with Channel Therapeutics, creating Pelthos Therapeutics.
- Launch of ZELSUVMI™ (berdazimer), the first FDA-approved home-administered treatment for molluscum contagiosum.
- $50.1 million equity capital raise, including $18 million investment from Ligand.
- Pelthos to trade on NYSE American under the symbol "PTHS".
Incidence and Prevalence
Global Epidemiology of Molluscum Contagiosum
Incidence and Prevalence
Molluscum contagiosum is a benign viral epidermal infection associated with high risk of transmission. Epidemiological data shows varying incidence and prevalence rates across different regions and populations.
In England and Wales, the incidence of molluscum contagiosum was 243/100,000 person-years in males and 231/100,000 in females based on data collected from 1994-2003. The relative risk of female to male incidence (all ages) was 0.95 (95% CI 0.91-0.99).
A meta-analysis suggests a point prevalence in children aged 0-16 years of between 5.1% and 11.5%. The largest incidence of Molluscum contagiosum (MC) is in children aged between 0 and 14 years, with incidence rates ranging from 12 to 14 episodes per 1000 children per year.
Age Distribution
90% of molluscum contagiosum episodes were reported in children aged 0-14 years, where incidence in 2000 was 1265/100,000 (95% CI 1240-1290). In the UK, incidence rates were highest in those aged 1-4 years.
In a Turkish study conducted from 2014 to 2019 with 286 pediatric patients, the overall mean age was 5.94±3.95 years. In children, molluscum contagiosum was most commonly seen in the 5-10-year age group (58 cases), followed by the 1-5-year age group (53 cases) according to an Indian study from 2000-2002.
Gender Distribution
The male-to-female sex ratio was 1.6:1 in children and 3.3:1 in adults based on the Indian study. In the Turkish study, 45.5% were girls and 54.5% were boys.
Regional Data
A study in Spain over 20 years (1988-2007) found 339 Molluscum contagiosum infections (2.7% incidence) with a yearly distribution ranging from 0% to 6.8%. There was a three-fold increase from an incidence of 1.3% in the first decade (1988-1997) to 4.0% in the second decade (1998-2007). Another Spanish study reported that molluscum contagiosum represented 0.37% of dermatology clinic patients over a year.
In a study from India (2000-2002), 150 cases included 137 children (85 male, 52 female) and 13 adults (10 male, 3 female).
Risk Factors and Associations
Risk factors include swimming pool use, age, living in close proximity, skin-to-skin contact, sharing of fomites, and residence in tropical climates. There is evidence for an association between swimming and having MC. MC is more common in those with eczema.
In one study of 140 cases, 51.43% of patients had a personal history of atopy and 72.1% used to attend swimming pools. Atopic dermatitis and swimming-pool attendance were associated with a higher frequency and number of molluscum contagiosum.
HIV infection appears to significantly affect the distribution and presentation of molluscum contagiosum, with 8 of 13 adults testing positive for HIV in one study.
Anatomical Distribution
The trunk was the most commonly involved region (56.6%) in the Turkish study. In both children and adults, the most common sites affected are the head and neck, followed by trunk, upper extremity, genitalia, and lower extremity.
Disease Duration
The median duration of the disease was 5 weeks (interquartile range: 3.00-12.00 weeks) according to the Turkish study.
Globally, molluscum contagiosum and condyloma acuminata are increasing throughout the world.
Risk Factors and Comorbidities
Risk Factors and Comorbidities for Molluscum Contagiosum
Top Risk Factors and Comorbidities
The top three risk factors and comorbidities for Molluscum contagiosum (MC) include:
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Immunosuppression/HIV Infection
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Immunosuppressed patients develop severe and recalcitrant molluscum lesions that may require treatment with cidofovir, imiquimod or interferon
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The incidence of MC in HIV patients is quite high at 5-8%
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Individuals with weakened immune systems are at greater risk for secondary inflammation and bacterial infection
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HIV-positive patients are prone to lesions that typically persist for prolonged periods
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Over the past 30 years, the incidence of Molluscum contagiosum has continued to increase in association with sexually transmitted infections and human immunodeficiency virus (HIV) infection
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Direct Contact Transmission
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Molluscum contagiosum is associated with high risk of transmission
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The disease can be transmitted by direct bodily contact including:
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Sexual activity - it is described as a sexually transmitted disease of increasing prevalence
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Fomites (contaminated objects)
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Self-inoculation
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Transmission usually occurs by direct contact with infected hosts
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Specific Dermatological Conditions
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Patients with atopic dermatitis showed a higher reactivity (P<.001) than healthy controls in antibody studies
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Patients with systemic lupus erythematosus also showed a higher reactivity (P<.001) than healthy controls
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In a study, antibodies to MCV were present in:
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7 (58%) of 12 patients with molluscum contagiosum
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7 (9%) of 76 with atopic dermatitis
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7 (18%) of 39 patients with systemic lupus erythematosus
Immunological Deficiencies and Immunosuppressive Conditions
The primary immunological deficiencies and immunosuppressive conditions that increase susceptibility to Molluscum contagiosum virus infection include:
- T-cell immunodeficiency appears to be associated with more difficult-to-treat molluscum contagiosum infections
- Acquired immune deficiency syndrome (AIDS) patients can develop molluscum contagiosum with confluent lesions on the eyelids
- In patients with AIDS, molluscum contagiosum can cause keratoconjunctivitis
- The humoral immune response to Molluscum contagiosum virus is usually confined to patients with the infection and may be affected by the immunological condition of the host
Dermatological Comorbidities
The dermatological comorbidities most frequently associated with Molluscum contagiosum lesions include:
- Atopic dermatitis - patients showed a higher reactivity (P<.001) than healthy controls
- Systemic lupus erythematosus - patients also showed a higher reactivity (P<.001) than healthy controls
Demographic and Environmental Risk Factors
Demographic and environmental risk factors that predispose individuals to Molluscum contagiosum include:
- 90% of molluscum contagiosum episodes were reported in children aged 0-14 years
- The incidence in males was 243/100,000 person-years and in females 231/100,000
- It may occur anywhere on the skin surface but is most common in skinfolds, on the face, and in the genital region
- Transmission through fomites (contaminated objects)
- Self-inoculation as a means of spreading the infection
HIV/AIDS Effects on Clinical Presentation and Management
HIV infection and AIDS affect the clinical presentation and management of Molluscum contagiosum in several ways:
- In patients with AIDS, molluscum contagiosum can form confluent lesions on the eyelids, which may cause keratoconjunctivitis
- Local removal of molluscum eyelid nodules appears to be of limited long-term value in patients with T-cell immunodeficiency
- Removal of lesions by surgery and cryotherapy was followed by recurrences in AIDS patients within 6 to 7 weeks
- HIV-positive patients are prone to lesions that typically persist for prolonged periods
- The MC159 and MC160 proteins encoded by MCV dampen several innate immune responses such as NF-κB activation and mitochondrial antiviral signaling (MAVS)-mediated induction of type 1 interferon (IFN)
- MCV encodes a variety of immune evasion molecules to dampen host immune responses, which may explain its persistence in immunocompromised hosts
Drug used in other indications
ZELSUVMI™ (Berdazimer) Clinical Trials Beyond Molluscum Contagiosum
Based on the available information, there is no data regarding ZELSUVMI™ (berdazimer) being trialed for indications other than Molluscum contagiosum. The existing information only discusses berdazimer gel, 10.3% in the context of treating Molluscum contagiosum.
Without additional information in the provided context, it is not possible to describe any other indications, intervention models, clinical trial designs, therapeutic protocols, or experimental methodologies for ZELSUVMI™ (berdazimer) beyond its use for Molluscum contagiosum.
