Today, news broke that Follicum had completed the supplementary toxicology studies that will form the basis for the upcoming phase II trial with their topical formulation of FOL-005. The study results were positive, safeguarding the company’s expectation to initiate the clinical study in early 2020.
When the peptide company Follicum announced positive results from supplementary toxicology studies today, it took a further step on the road to clinical phase II with the topical formulation of their lead candidate, FOL-005. The supplementary studies were required by the German authorities in order for Follicum to be allowed to commence the planned clinical study. The reason being that the formulation to be tested in humans is a new formulation of the candidate.
A user-friendly formulation
In previous phase I and phase II studies, patients were treated with FOL-005 through intradermal injections of a subcutaneous formulation. Follicum has now developed an off-the-shelf formulation in order to promote the user-friendly aspect of the candidate as well as its commercial prospects. It is this topical cream, which is applied to the scalp, that is now to be tested in upcoming clinical trials.
Supplementary toxicology studies done
FOL-005 is being developed as a treatment against a form of hair loss called alopecia. The candidate has previously achieved good results in both phase I and phase II where FOL-005 proved to be a safe and effective treatment for men in the early stages of baldness. The positive toxicology study results that the company announced today were the final step before the upcoming phase II study with the new topical formulation. The company is now preparing an application for trial approval by the German authorities with the aim of initiating the study in early 2020. The aim is to investigate the hair growth stimulating effect following treatment with varying doses of the topical formulation of FOL-005 and thus establish Proof-of-Concept.
Prepared for phase IIa
This summer Follicum conducted two parallel rights issues and raised a total of 54 MSEK. In April the company applied for a patent for the new topical formulation that, if approved, would extend the patent protection by eight years until
2040. Supported by this and the production of clinical material of the topical formulation of FOL-005 through a deal with Bioglan, Follicum is ready for the upcoming study.
The company has previously stated its ambition to reach a partnering or license deal following phase IIa studies at the latest. If Follicum continues to deliver in accordance with the communicated time plan they will be able to show top-line data during autumn 2020, which, under the right circumstances has the potential to be very significant in negotiations with potential partners and other interested parties.
CEO Jan Alenfall commented on the positive results in a press release:
– The outcome of both the new and the previous toxicology studies shows that FOL-005 does not give rise to any negative effects or injuries. Other preparations for the clinical trial are in full swing. The upcoming clinical trial is planned to be conducted in Germany where Follicum has good previous experience. The company intends to submit the application for starting the phase IIa study on alopecia patients with the new formulation to the German Medical Products Agency in the autumn of 2019.
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