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BioPharm Insight: Cynapsus seeking CRO for studies of lead PD agent; plans to find global partner post completion of pivotal study - CEO

March 23, 2022

By Anusha Kambhampaty

Cynapsus Therapeutics (CVE:CTH) is currently engaging in discussions with CROs to help run a Phase I study of lead agent APL-130277, a sublingual formulation of apomorphine, an approved agent used to treat “off-episodes” of patients with advanced Parkinson’s disease (PD), CEO Anthony Giovinazzo said. The Phase I trial is expected to initiate this July or August and the company will likely hire the CRO by June, Giovinazzo noted.

The CEO added that a CRO will also be hired in Q4 for a larger pivotal study, which is likely to commence in January.

A CRO with experience running Phase I studies along with expertise in the PD field is desired, the CEO noted.

The Phase I trial will consist of an eight-week long study of APL-130277 in 36 healthy volunteers followed by a 16-week long assessment of the agent in 40 advanced stage PD patients who experience daily off-periods lasting at least one hour in length, Giovinazzo said. The full Phase I study should complete by the end of this year, he noted.

The pivotal study will consist of two small studies, 18 and 30 patients in size, followed by a larger, 100 patient study, Giovinazzo said. All three studies are expected to conclude by December 2012, or January 2013, at the latest, he added. The two smaller studies should take approximately four to five months and the larger study is then expected to initiate in the spring or summer of 2012, Giovinazzo noted. The studies will enroll PD patients with a similar disease profile as described in the Phase I study, he said.

APL-130277 is expected to undergo accelerated approval through the FDA 505(b)(2) process.

According to Giovinazzo, 10 to 30% of PD patients experience off-episodes, which consist of periods of immobility in between PD treatments. Prolonged use of PD drugs exacerbates the problem, he said.

While apomorphine is the “best rescue therapy” for patients who experience off-episodes, its subcutaneous formulation makes it difficult to administer, Giovinazzo explained, noting that injection site related adverse effects are also prevalent with the use of apomorphine.

Cynapsus’ agent, a thin-strip formulation of apomorphine, dissolves under the tongue in one to two minutes, Giovinazzo said. The sublingual formulation shares the same 45 minute half life as the subcutaneous version, he added, noting that a thin-strip would be easier to take, while allowing patients to be mobile.

The CEO noted that the company intends to partner APL-130277 following completion of the pivotal study. A global partner is ideal, though the company would also consider appropriate regional partnerships, Giovinazzo said, noting that the company has engaged in “some discussions.” The primary role of the partner would be in assembling the NDA package of prior studies and managing the regulatory approval process, along with post-approval marketing, the CEO said. He added that the NDA is expected to be submitted mid to late 2013.

With regards to potential partners, Giovinazzo named GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN), Sanofi-Aventis (SAN FP) and Biogen Idec (NASDAQ:BIIB) as examples.

Giovinazzo also indicated the company is open to being acquired. If several parties are bidding for a global or regional license, “we could envision an acquisition scenario,” he said.

The company announced last December the engagement of Summer Street Research Partners.

Cynapsus has a current market cap of CAD 4.46m.

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