Dermatology | Phase I/ Phase II Developments

Forte Biosciences

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Forte Biosciences, Inc. Announces Issuance of New U.S. Patent

Lead Product(s): FB-401

Therapeutic Area: Dermatology Product Name: FB-401

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

Details:

Forte Biosciences announced the issuance of its seventh U.S. patent (10,682,379), broadening protection to include methods for culturing gram negative bacteria from the skin.

Forte Biosciences

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Forte Biosciences, Inc. Announces Closing of Merger With Tocagen

Lead Product(s): FB-401

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Tocagen

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Merger June 15, 2020

Details:

As per the merger agreement, stockholders of Forte have become the majority owners of Tocagen, and the operations of Forte and Tocagen have combined.

Histogen

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Histogen Begins Enrollment in Phase 1b/2a Trial of HST 001 to Treat Androgenic Alopecia

Lead Product(s): HST 001

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

Details:

This blinded, randomized, placebo controlled, single site study is designed to assess the safety and tolerability of HST 001, and indicators of efficacy including non-vellus hair count, total hair count, and hair thickness density as measured by Canfield macrophotography.

Histogen

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Histogen Receives US FDA IND Approval to Initiate Phase 1b/2a Trial of HST 001 in Androgenic Alopecia

Lead Product(s): HST 001

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2020

Details:

Under this IND, Histogen intends to initiate a Phase 1b/2a clinical trial of HST 001, a Hair Stimulating Complex (HSC), in the second quarter of 2020.

Arcutis Biotherapeutics

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Arcutis Announces Enrollment of First Patient in Phase 1/2b Study of ARQ-252 in Patients with Chronic Hand Eczema

Lead Product(s): ARQ-252

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2020

Details:

Arcutis has enrolled the first patient in Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule inhibitor of JAK1, in adult patients with chronic hand eczema.

Forte Biosciences

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Tocagen and Forte Biosciences Announce Merger

Lead Product(s): FB-401

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Alger

Deal Size: $25.0 million Upfront Cash: Undisclosed

Deal Type: Merger February 19, 2020

Details:

The merged company will focus on advancing Forte's clinical program in inflammatory skin diseases, including atopic dermatitis.

Krystal Biotech

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Krystal Biotech investing up to $90M on facility for its gene therapies

Lead Product(s): B-VEC

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase II Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Investment January 24, 2020

Details:

Krystal Biotech intends to make the clinical material for an upcoming phase 3 trial of B-VEC at its Ancoris facility and anticipates starting the trial in Q1 2020.

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Find Dermatology Drugs in Phase I/II Clinical Development

Phase I/ Phase II

Product Type

Companies

Forte Biosciences

Forte Biosciences, Inc. Announces Issuance of New U.S. Patent

Forte Biosciences

Forte Biosciences, Inc. Announces Closing of Merger With Tocagen

Histogen

Histogen Begins Enrollment in Phase 1b/2a Trial of HST 001 to Treat Androgenic Alopecia

Histogen

Histogen Receives US FDA IND Approval to Initiate Phase 1b/2a Trial of HST 001 in Androgenic Alopecia

Arcutis Biotherapeutics

Arcutis Announces Enrollment of First Patient in Phase 1/2b Study of ARQ-252 in Patients with Chronic Hand Eczema

Forte Biosciences

Tocagen and Forte Biosciences Announce Merger

Krystal Biotech

Krystal Biotech investing up to $90M on facility for its gene therapies