A Single-center, Randomized Double-blind, Vehicle-controlled, Dose-ranging Decentralised Clinical Trial to Evaluate the Safety and Efficacy of Daily Field-directed Topical Applications of AVX001 Silicone-based Gel in Doses of 1% or 3% in Adult Subjects With Multiple Actinic Keratosis Lesions Olsen Grade 1 or 2

Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer.
The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.

Start Date02 Nov 2021

Sponsor / Collaborator

Coegin Pharma AB

[+1]

NCT04774874

/ CompletedPhase 2

A Randomized, Double-blind, Vehicle-controlled, Dose-finding Multi-center, Phase 2a Trial of FOL-005 Topical Formulations to Investigate Hair Growth Potential and Safety in Healthy Male Volunteers With Androgenetic Alopecia

This exploratory phase IIa, double blind, randomized, vehicle controlled, multicenter dose-finding trial will evaluate the safety, tolerability, and efficacy of FOL-005 topical formulation (at 0.1%, 0.5% and 1.5% strength) administered once daily (in the evening) for 16 weeks in healthy male subjects with androgenetic alopecia.

Start Date24 Jun 2020

Sponsor / Collaborator

Follicum AB

[+2]

EUCTR2019-004305-26-DE

/ Not yet recruitingPhase 2

A randomized, double-blind, vehicle-controlled, dose-finding, multi-center, phase 2a trial of FOL-005 topical formulations to investigate hair growth potential and safety in healthy male volunteers with androgenetic alopecia.

Start Date29 Jan 2020

Sponsor / Collaborator

Follicum AB

100 Clinical Results associated with Coegin Pharma AB

0 Patents (Medical) associated with Coegin Pharma AB

Literatures (Medical) associated with Coegin Pharma AB

01 Jul 2024·PHARMACOLOGICAL RESEARCH

Identification of an osteopontin-derived peptide that binds neuropilin-1 and activates vascular repair responses and angiogenesis

Article

Author: Caing-Carlsson, Rhawnie ; Walse, Björn ; Nilsson, Anna Hultgårdh ; Shen, Junyan ; Nilsson, Jan ; Gialeli, Chrysostomi ; Duelli, Annette ; Zibert, John R ; Liang, Chun ; Dunér, Pontus ; Chen, Yihong ; Alenfall, Jan ; Blom, Anna M

The osteopontin-derived peptide FOL-005 stimulates hair growth. Using ligand-receptor glyco-capture technology we identified neuropilin-1 (NRP-1), a known co-receptor for vascular endothelial growth factor (VEGF) receptors, as the most probable receptor for FOL-005 and the more stable analogue FOL-026. X-ray diffraction and microscale thermophoresis analysis revealed that FOL-026 shares binding site with VEGF in the NRP-1 b1-subdomain. Stimulation of human umbilical vein endothelial cells with FOL-026 resulted in phosphorylation of VEGFR-2, ERK1/2 and AKT, increased cell growth and migration, stimulation of endothelial tube formation and inhibition of apoptosis in vitro. FOL-026 also promoted angiogenesis in vivo as assessed by subcutaneous Matrigel plug and hind limb ischemia models. NRP-1 knock-down or treatment of NRP-1 antagonist EG00229 blocked the stimulatory effects of FOL-026 on endothelial cells. Exposure of human coronary artery smooth muscle cells to FOL-026 stimulated cell growth, migration, inhibited apoptosis, and induced VEGF gene expression and VEGFR-2/AKT phosphorylation by an NRP-1-dependent mechanism. RNA sequencing showed that FOL-026 activated pathways involved in tissue repair. These findings identify NRP-1 as the receptor for FOL-026 and show that its biological effects mimic that of growth factors binding to the VEGF receptor family. They also suggest that FOL-026 may have therapeutical potential in conditions that require vascular repair and/or enhanced angiogenesis.

01 Feb 2024·Contemporary clinical trials communications

Accelerating patient recruitment using social media: Early adopter experience from a good clinical practice-monitored randomized controlled phase I/IIa clinical trial on actinic keratosis

Article

Author: Laugesen, Charlotte Amalie Pind ; Haedersdal, Merete ; Budnik, Olena ; Ortner, Vinzent Kevin ; Havsager, Signe ; Manole, Ionela ; Zibert, John R

Background:

Patient recruitment is a major cause of delays in randomized controlled trials (RCT). Online recruitment is evolving into an alternative to conventional in-clinic recruitment for RCT. The objective of this study was to test the effectiveness of online patient recruitment for an RCT on actinic keratosis (AK).

Methods:

In this proof-of-concept study, adults with AK were recruited for a Phase I/IIa RCT (NCT05164393) via social media using targeted advertising Interested users were directed to a landing page to learn about the study, respond to questionnaires, and upload self-obtained smartphone pictures of potential AK. Facebook Analytics was used to track the number of advertisement views, individual users exposed to the advertisement, and advertisement clicks. Following eligibility-review by remote dermatologists, candidates were contacted for an in-clinic visit. A review of pertinent RCTs on AK (2012-2022) was conducted to compare recruitment metrics.

Results:

The online campaign served 886,670 views, reached 309,000 users, and generated 27,814 clicks. A total of 556 users underwent eligibility review, leading to 140 pre-evaluated potential study subjects. The RCT's enrollment target of 60 patients (68.8 ± 7.1 years, 43.3 % female) was reached in 53 days after screening 90 participants in-clinic, corresponding to a screen failure rate of 33.3 %. The total cost of this online recruitment campaign was 14,285 USD i.e. 238 USD per randomized patient. Compared to the existing literature (44 RCTs), our online approach resulted in 9 times more time-efficient recruitment per site.

Conclusion:

Using targeted advertisements, 60 patients with AK were recruited for a single-center Phase I/IIa RCT in 53 days. Social media appears to be an efficient platform for online recruitment of patients with low-grade AK for RCT.

15 Sep 2023·The British journal of dermatology

Agreement and reliability of remote assessment of actinic keratosis: a proof-of-concept study using smartphone photographs.

Article

Author: Andersen, Anders Daniel ; Mondragón, Alejandro Castillo ; Ortner, Vinzent Kevin ; Manole, Ionela ; Haedersdal, Merete ; Zibert, John R

News (Medical) associated with Coegin Pharma AB

20 Aug 2025

·www.coeginpharma.com

Coegin Pharma provides status update ahead of the upcoming commercialisation of its first Follicopeptide-based hair growth product

The company is pleased to inform that the commercialisation of the first Follicopeptide-based product, expected by the end of this year, is firmly on schedule. Commercial scale production is secured in Denmark, and raw material is ordered for the first batches. The regulatory process and negotiations with relevant partner companies are also progressing firmly. Coegin Pharma is entering a transformative phase as preparations for the commercialisation of its first Follicopeptide-based product advance according to plan. This milestone marks the company's transformation from an R&D-focused biotech towards a revenue-generating commercial enterprise. Commercial-scale production capabilities have been secured in Denmark, ensuring both product development capacity and full-scale manufacturing. Raw materials have already been ordered, and the bottles will be ordered in the coming weeks. Production of the first commercial batch is set to start in September. Regulatory preparations are progressing as planned, with the submission of the Product Information File (PIF) scheduled for this autumn - well ahead of the launch. Meanwhile, negotiations with potential partners for initial purchase orders and batch sizing are underway. The EU remains a priority market for the launch, while other markets such as the US, China, South Korea and Brazil are also in focus. The first Follicopeptide product will be delivered in a ready-to-use, attractive bottle, branded by the partner. Potential boxes for the bottles will be tailored to market specific needs. "This is an incredibly intense and exciting time - we are witnessing a defining moment in Coegin Pharma's history," says Jens Eriksson, CEO of Coegin Pharma. "We are taking the big leap from being a development-stage biotech towards becoming a commercial company with real revenue and cash flow. This is the start of an entirely new chapter for Coegin Pharma, and I look forward to sharing more details about the launch soon." With production secured, regulatory milestones on track, and commercial discussions accelerating, Coegin Pharma is poised to bring its breakthrough Follicopeptide innovation to market - unlocking a new era of scientifically grounded hair growth solutions. For further information, please contact: Jens Eriksson, CEO Email: info@coeginpharma.com About Coegin Pharma Coegin Pharma is a Swedish biotech company developing cutting-edge innovations for hair and skin. The company aims to commercialise a series of hair growth products starting in late 2025, followed by a pigmentation product in 2026. The company's vision is: "To lead the future of cutting-edge solutions for hair and skin longevity". Coegin Pharma's share is listed on NGM Nordic SME and dual-listed on Börse Stuttgart. The company is headquartered in Lund, Sweden. More information - including subscription to company updates and links to social media - is available at coeginpharma.com Attached files

12 Aug 2025

·www.coeginpharma.com

Coegin Pharma changes language for company communication to English

Coegin Pharma hereby announces that the company will change its language for communication to English only. This means that financial reports and press releases will henceforth be published exclusively in English. Coegin Pharma operates in a global market and has an extensive network of international stakeholders. By transitioning to English as the language of communication, the company aims to create more consistent and effective communication, simplifying the dissemination of information to its stakeholders. Historical press releases and financial reports in Swedish will remain available on the company's website. For further information, please contact: Jens Eriksson, CEO Email: info@coeginpharma.com About Coegin Pharma Coegin Pharma is a Swedish biotech company developing cutting-edge innovations for hair and skin. The company aims to commercialise a series of hair growth products starting in late 2025, followed by a pigmentation product in 2026. The company's vision is: "To lead the future of cutting-edge solutions for hair and skin longevity". Coegin Pharma's share is listed on NGM Nordic SME and dual-listed on Börse Stuttgart. The company is headquartered in Lund, Sweden. More information - including subscription to company updates and links to social media - is available at coeginpharma.com Attached files

02 Jul 2025

·www.coeginpharma.com

Coegin Pharma has reduced product cost by 80 percent - moving closer to the launch of Follicopeptide

Coegin Pharma is approaching the launch of its first hair growth product based on Follicopeptide. Through focused development efforts, the company has so far reduced the cost of manufacturing a finished product by over 80 percent, while also refining function, design and market adaptation ahead of the planned launch in late 2025. The company is now focusing on optimising the product in terms of both user experience and commercial appeal. A new, fully developed prototype has been created - a syringe-inspired bottle with a smart, lockable click system that delivers the correct dose and an integrated applicator tip that enables hygienic and effective application. The design signals a science-based premium product in the hair growth segment. Watch a short video where CEO Jens Eriksson presents the prototype: https://www.youtube.com/shorts/EsRdREoWu3Q The finished product has been developed with support from extensive market research conducted in several parts of the world. It is designed to meet both consumer expectations and the demands of potential partner companies in terms of design, function and, not least, price. Coegin has chosen to develop a finished product in order to present a proof of concept for production - and to simplify and shorten the time to market through partners, by offering an attractive, ready-to-launch product. When launching through partners, product cost is a critical factor - especially in the premium segment, where initial marketing efforts require healthy margins. The cost reduction achieved so far strengthens Coegin's position in negotiations with commercial partners. The product is expected to be offered in different concentrations depending on market, price point and sales channel. "I am very proud of the solid development work we have carried out. Thanks to collaborations with development partners and deep market insights, we have created a product with global potential. Being able to present a fully developed product and a functional manufacturing process at this stage is a valuable strategic tool in our partner discussions," says Jens Eriksson, CEO of Coegin Pharma. For further information, please contact: Jens Eriksson, CEO Email: info@coeginpharma.com This document is a translation of the original Swedish press release. In case of any discrepancies, the Swedish version shall prevail. About Coegin Pharma Coegin Pharma is a Swedish biotech company developing cutting-edge innovations for hair and skin. The company aims to commercialise a series of hair growth products starting in late 2025, followed by a pigmentation product in 2026. The company's vision is: "To lead the future of cutting-edge solutions for hair and skin longevity". Coegin Pharma's share is listed on NGM Nordic SME and dual-listed on Börse Stuttgart. The company is headquartered in Lund, Sweden. More information - including subscription to company updates and links to social media - is available at coeginpharma.com/en. Attached files

100 Deals associated with Coegin Pharma AB

100 Translational Medicine associated with Coegin Pharma AB

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Pipeline

Pipeline Snapshot as of 24 Sep 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

AVX-001 ( cPLA2α )	Actinic Keratosis More	Phase 2
FOL-005 ( NRP-1 )	Wounds and Injuries More	Phase 1
FOL-00X ( NRP-1 )	Hirsutism More	Preclinical
FOL-014 ( NRP-1 )	Diabetes Mellitus More	Preclinical
AVX-420 ( cPLA2α )	Leukemia More	Preclinical

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