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MOR106

Phase 2

Dermatitis, Atopic | Small molecule | Dermatology |Lakefront Biotherapeutics|Trials Updated: Oct 5, 2017

MOR106 development status

Highest phase Phase 2 (NCT03864627)
Phase scored for LKFTPhase 1
Registered trials 2 across 1 sponsor since Sep 2018

MOR106 target and mechanism

ModalitySmall molecule

Also known as MOR106 single ascending doses

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

MOR106 clinical trials

MOR106 · 1 trial · 2 indications

Phase 1 1
NCT02739009First in Human of Single and Multiple Doses of MOR106Healthy
COMPLETED81 Analytics
PHASE1COMPLETED
First in Human of Single and Multiple Doses of MOR106
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Study Endpoints

Primary Endpoints

Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with deviating physical examination results
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal vital signs
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the number of subjects with abnormal laboratory findings
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Difference as compared to placebo in the occurrence of infusion related reactions
Up to 99 days after dosing

To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo

Secondary Endpoints

Serum concentration (Cinf) of MOR106
up to 99 days after dosing
Area under the curve (AUC) of MOR106
up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106
up to 99 days after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MOR106EXPERIMENTALSingle intravenous administration of MOR106
PlaceboPLACEBO_COMPARATORSingle intravenous administration of Placebo
MOR106 MADEXPERIMENTALMultiple intravenous administration of MOR106
Placebo MADPLACEBO_COMPARATORMultiple intravenous adminstration of Placebo

Interventions

NameTypeDescription
MOR106 single ascending doses, intravenousDRUG -
Placebo single ascending doses, intravenousDRUG -
MOR106 multiple ascending doses, intravenousDRUG -
Placebo multiple intravenous administrationsDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: \- Able and willing to give voluntary written informed consent Single ascending dose (SAD) * Negative urine drug screen * Male between 18-50 years of age * A body mass index (BMI) between 18-30 kg/m², inclusive. * Judged to be in good health Multiple ascending dose (MAD) * M...

Countries:BelgiumHungaryMoldovaRomania
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Frequently asked questions about MOR106

What is MOR106?

MOR106 is an investigational small molecule developed by Lakefront Biotherapeutics for atopic dermatitis, a form of eczema. It has been studied in a Phase 1 first-in-human trial that enrolled 81 participants, including healthy volunteers and people with atopic dermatitis. MOR106 is not approved and remains in clinical development.

What is MOR106 used for in atopic dermatitis?

MOR106 is being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. Its clinical testing has focused on this dermatology indication, with a Phase 1 trial that included participants with atopic dermatitis alongside healthy volunteers. It is investigational and has not been approved for any use.

Who makes MOR106?

MOR106 is developed by Lakefront Biotherapeutics, which trades under the ticker LKFT. The company is the sponsor of the drug's clinical program in atopic dermatitis.

What phase is MOR106 in?

MOR106 is in Phase 1 development. Its only recorded trial, NCT02739009, was a Phase 1 first-in-human study that has been completed. The drug is investigational and has not received regulatory approval.

What clinical trials is MOR106 in?

MOR106 has been evaluated in one clinical trial, NCT02739009, titled First in Human of Single and Multiple Doses of MOR106. This completed Phase 1 study enrolled 81 participants across Belgium, Hungary, Moldova, and Romania and included healthy volunteers and patients with atopic dermatitis.

Is MOR106 the same as MOR106 single ascending doses, intravenous?

Yes. MOR106 single ascending doses, intravenous and MOR106 single ascending doses are alternative names used for MOR106, the investigational small molecule from Lakefront Biotherapeutics being studied in atopic dermatitis. These names refer to the same drug asset and its Phase 1 clinical program.