Evaluation of PYM50018 in a preclinical model of glaucoma

Phytopharm is a small pharmaceutical development company (designated as an SME by
EMA and eligible for R & D relief for Corporation tax under the SME scheme), which
outsources all studies to expert providers whilst retaining programme management and
strategic decision-making in house. The Company currently has extremely limited financial
resources available for new research and development (R&D) activities outside of its core
development project, a large, multicentre, Phase II proof-of-concept (PoC) and dose ranging
study of its lead asset Cogane, in patients with early stage Parkinson’s disease (PD).
Exciting new data from one of the Company’s preclinical programmes has shown that the
compound PYM50018 is able to reverses glutamate-induced neuronal damage in retinal
ganglion cells (RGCs) in vitro. These data, coupled with the proven ability of this orally
active compound to induce neurotrophic factor expression in vivo and the considerable preexisting
toxicology, safety pharmacology and Phase I clinical data packages supporting this
compound, has led the Company to explore all means of accelerating the development of
PYM50018 for the treatment of glaucoma and to move towards commencing a PoC study in
an appropriate animal model as soon as possible. If such a study is successful, a clinical PoC
study in patients with glaucoma could be rapidly progressed.
Demonstrating PoC in a relevant animal model of glaucoma within a 6-9 month timeframe
would lead to funding opportunities for the Company, either by partnering or via the financial
markets. This would significantly de-risk Phytopharm’s pipeline and provide an opportunity
for a revenue stream comprising an upfront payment, development milestones and royalties
on future sales of a novel therapeutic for the treatment of glaucoma. It is the Company’s
opinion that positive data in the proposed study would be sufficient for the Company to attract
the interest of some of the key players in glaucoma e.g., Alcon (Novartis), Allergan, Pfizer,
Merck, Santen Seiyaku.
Although the cost of the proposed PoC study in a rat model of glaucoma is modest, the
Company’s commitment to it’s Parkinson’s disease programme and the uncertainties around
completion and delivery of the aforementioned clinical study mean that the Company is
unable to fund this work at the present time. Securing funding from the Technology Strategy
Board (TSB) would enable this important study to be progressed during the second half of this
year and we feel, fit well with the Board’s aim of supporting the technical feasibility and
commercial potential of new healthcare technologies and medicines through specialist testing
and preclinical research studies.