Dermatology | Phase I Developments

Bio-Thera Solutions Ltd

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CHINA China

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Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

Lead Product(s): Ustekinumab

Therapeutic Area: Dermatology Product Name: BAT2206

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2020

Details:

Company has begun dosing patients in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.

ASLAN Pharmaceuticals

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Singapore

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ASLAN Pharmaceuticals Resumes Recruitment of New Patients Into ASLAN004 Study

Lead Product(s): ASLAN004

Therapeutic Area: Dermatology Product Name: ASLAN004

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

Details:

ASLAN Pharmaceuticals has resumed patient recruitment into its randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study of ASLAN004 in moderate to severe atopic dermatitis.

Gesynta Pharma

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SWEDEN Sweden

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Gesynta raises SEK 190M in Round Led by Hadean Ventures to Accelerate Development of First-in-Class mPGES-1 Inhibitor GS-248

Lead Product(s): GS-248

Therapeutic Area: Dermatology Product Name: GS-248

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Hadean Ventures

Deal Size: $21.1 million Upfront Cash: Undisclosed

Deal Type: Financing July 07, 2020

Details:

The investment enables Gesynta to fund continued development of lead candidate GS-248 in systemic sclerosis patients.

InMed Pharmaceuticals

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CANADA Canada

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InMed Announces Dosing Initiation in 2nd Phase 1 Trial with INM-755

Lead Product(s): Cannabinol

Therapeutic Area: Dermatology Product Name: INM-755

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

Details:

The 755-102-HV clinical trial is a randomized, double-blind, vehicle-controlled, Phase 1 study designed to evaluate the safety and tolerability of INM-755 cream applied daily on epidermal wounds in healthy volunteers.

Azitra

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United States

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Azitra Awarded U.S. Composition of Matter Patent Covering Engineered Bacterial Strains for Treating Skin Conditions

Lead Product(s): Recombinant Staphylococcus epidermidis

Therapeutic Area: Dermatology Product Name: ATR-04

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

Details:

The patent includes broad composition of matter claims that cover the Company’s engineered bacterial strain discovery platform, are central to its programs for treating skin diseases, and provide a significant barrier to entry for competitors.

Conatus Pharmaceuticals

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Histogen Announces Successful Completion of its Merger with Conatus Pharmaceuticals

Lead Product(s): HST 001

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Histogen

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger May 27, 2020

Details:

This merger is transformative for Histogen as it looks to advance its novel regenerative medicine pipeline. The merger provides an opportunity for Histogen to become a leader in the aesthetics and orthopedic medicine markets.

Rapt Therapeutics

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United States

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RAPT Therapeutics Highlights Early Results for RPT193 at Society for Investigative Dermatology Meeting

Lead Product(s): RPT193

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 15, 2020

Details:

In multiple preclinical studies of allergic skin inflammation, once-daily dosing of RPT193 demonstrated efficacy and reduction of Th2 cytokines comparable to treatment with currently available biologics that work by blocking interleukin-4 (IL-4) and IL-13.

TWi Biotechnology

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TAIWAN Taiwan

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TWiB Receives Canada Health Approval for AC-1101 Phase 1 CTA

Lead Product(s): Tofacitinib Citrate

Therapeutic Area: Dermatology Product Name: AC-1101

Highest Development Status: Phase I Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2020

Details:

Health Canada has approved Ancheng Biotech's open-label, fixed-sequence, two-period, comparative bioavailability study of AC-1101 (Tofacitinib Citrate). Tofacitinib Citrate is a topical JAK inhibitor for the treatment of vitiligo.

ASLAN Pharmaceuticals

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Singapore

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ASLAN Pharmaceuticals Temporarily Pauses Recruitment of New Patients Into ASLAN004 Study Due to COVID-19

Lead Product(s): ASLAN004

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 13, 2020

Details:

Recruitment of new patients into its study of ASLAN004 in moderate to severe atopic dermatitis has been paused in light of recently imposed government restrictions in Singapore.

Histogen

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United States

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Histogen Announces Investigational New Drug Application Amendment for HST 001

Lead Product(s): HST 001

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2020

Details:

Histogen has submitted IND amendment with the U.S. FDA for the initiation of a Phase 1b/2a clinical trial of its lead program, HST 001 for the treatment of androgenic alopecia in men.

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Find Dermatology Drugs in Phase I Clinical Development

Phase I

Product Type

Companies

Bio-Thera Solutions Ltd

Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

ASLAN Pharmaceuticals

ASLAN Pharmaceuticals Resumes Recruitment of New Patients Into ASLAN004 Study

Gesynta Pharma

Gesynta raises SEK 190M in Round Led by Hadean Ventures to Accelerate Development of First-in-Class mPGES-1 Inhibitor GS-248

InMed Pharmaceuticals

InMed Announces Dosing Initiation in 2nd Phase 1 Trial with INM-755

Azitra

Azitra Awarded U.S. Composition of Matter Patent Covering Engineered Bacterial Strains for Treating Skin Conditions

Conatus Pharmaceuticals

Histogen Announces Successful Completion of its Merger with Conatus Pharmaceuticals

Rapt Therapeutics

RAPT Therapeutics Highlights Early Results for RPT193 at Society for Investigative Dermatology Meeting

TWi Biotechnology

TWiB Receives Canada Health Approval for AC-1101 Phase 1 CTA

ASLAN Pharmaceuticals

ASLAN Pharmaceuticals Temporarily Pauses Recruitment of New Patients Into ASLAN004 Study Due to COVID-19

Histogen

Histogen Announces Investigational New Drug Application Amendment for HST 001